Search Results

Neuro:

• Neurosurgery
• Nasoethmoidal fractures
• Infraorbital area fractures
• Frontal sinus wall Fractures
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:

• Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery
• Neurosurgery: osteosynthesis of the cranial bones.

Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandbular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Dental: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:
• Nasoethmoidal fractures

• Infraorbital area fractures
• Frontal sinus wall fractures ●
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

Dental: DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.

The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.

The DePuy Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The clamp shaft consists of a 1.6 mm tube which is secured to the bottom disc. The top disc has a thickness of 0.4 mm and the plate diameters range from 8.0 to 20. mm.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.

Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.

The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.

The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium alloy and are intended for single use only.

The DePuy Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. The DePuy Synthes 1.6 mm Burr Hole Covers have 5 lobes to accommodate a shunt/drain and are available in 12, 15, 17, and 24 mm diameters with a plate thickness of 0.5 mm.

The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, infants, and neonates. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs. The distractor body is first assembled with the desired footplates, and then the footplates are secured to bone using the bone screws. After implantation the distractor is activated through the rotation of an advancement/lead screw with an activation instrument percutaneously.

The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) regarding several DePuy Synthes Craniomaxillofacial Neuro Devices. It describes changes to the labeling of these devices to indicate "MR Conditional" use.

The document consistently states that the purpose of the submission is to add MR Conditional information to the device labeling. It explicitly mentions that the intended use and technological characteristics of the devices remain unchanged. This implies that the devices are already cleared for their stated indications and the current submission is concerned with demonstrating their safety in an MR environment.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to support the MR Conditional safety of the devices. This is not a study proving clinical effectiveness or diagnostic accuracy of an AI/algorithm-based device, but rather a set of engineering tests to confirm a physical device's compatibility with an MR environment.

Based on the provided text, here's how to address your request:

1. A table of acceptance criteria and the reported device performance:

The document repeatedly cites the ASTM standards as the basis for performance testing, which inherently contain acceptance criteria within them. The document does not provide specific quantitative performance results for each device against these criteria, but rather states that "Non-clinical testing is provided to support the conditional safety." This implies that the devices met the acceptance criteria defined by these ASTM standards.

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document does not specify the number of individual devices or prototypes tested for each type of assessment (displacement, torque, heating, artifacts). These are engineering tests typically performed on representative samples.
• Data Provenance: The data provenance is "non-clinical testing" conducted by the manufacturer, DePuy Synthes. The "DUKE model" for RF heating is mentioned, which is a widely accepted phantom model for electromagnetic simulations in medical device testing. There's no information about the country of origin of the data beyond it being part of a US FDA submission. It is a prospective test in the sense that the testing was conducted to support the MR Conditional labeling.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable in the context of this submission. The "ground truth" for MR Conditional safety is established by engineering tests against recognized consensus standards (ASTM), not by human expert review of clinical cases. The tests directly measure physical properties like temperature increase or magnetic force, and these measurements are compared to the limits specified in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a human reader study requiring adjudication. The assessment is based on objective physical measurements and adherence to ASTM standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for physical medical devices (implants), not an AI/algorithm-based diagnostic or assistive software. No MRMC study was performed because the device is not an AI reading tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm, so standalone performance is irrelevant. The tests are for the physical properties of the implants.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The "ground truth" for these tests is defined by the physical laws and empirically derived thresholds outlined in the ASTM standards for MR compatibility. For example, a certain temperature rise in a standard phantom model is deemed acceptable if it remains below a specified limit.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Ask a specific question about this device

DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165)
The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K113567)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656)
The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233)
The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144)
The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388)
The DePuy Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use:

• Fractures of the midface and maxillofacial skeleton
• LeFort I osteotomies, sagittal split osteotomies and genioplasties
• Orthognathic surgery including reconstructive procedures

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K082335)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331)
The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton, maxillofacial surgery, reconstructive procedures and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K063790)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K050608)
The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Neuro Plate and Screw System (originally cleared per K042365)
The DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121)
The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Orbital Plates (originally cleared per K031761)
The DePuy Synthes Orbital Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Low Profile Neuro System (originally cleared per K022012)
The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midfacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Midface Distractor (Originally cleared per K022005)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.

DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505)
The DePuy Synthes Translating Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.

DePuy Synthes Midface Distractor (Originally cleared per K010499)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.

DePuy Synthes Maxillary Distractor (Originally cleared per K003393)
The DePuy Synthes Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.

DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311)
The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555)
The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421)
The DePuy Synthes 2.4 mm Universal Locking Plate and screw system, that is intended for mandible trauma and reconstruction procedures.

DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385)
The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:

• Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery

DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932)
General indications:

• Maxillofacial surgery

DePuy Synthes MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The DePuy Synthes MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6A1-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the DePuy Synthes MatrixMANDIBLE Plate and Screw System. These devices are offered, non-sterile and must be sterilized prior to use. DePuy Synthes MatrixMANDLBLE screws are intended for single use.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile or non-sterile (non-sterile implants must be sterilized prior to use). DePuy Synthes MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

The DePuy Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. Screws: The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self drilling tips. Screws are manufactured from titanium alloy (Ti-6A1-7Nb). Plates and Meshes: The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.

The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium alloy and are intended for single use only.

The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with DePuy Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.

The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.

The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.

The DePuy Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile/non-sterile and for single use only.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, meshes, and screws in a variety of shapes and sizes designed for various maxillofacial procedures.

The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.

The DePuy Synthes Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.

The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.

The DePuy Synthes Maxillary Distractor is an intra-oral distraction device. It features two telescoping components, with contourable legs having screw holes, that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.

The DePuy Synthes Orbital Mesh Plates have a semi-circular shape with a radially designed mesh pattern. Orbital Mesh Plates are available in 0.2, 0.3 and 0.4 mm profile thickness. Standard 1.0 mm screw holes positioned along the outer arc of the Orbital Mesh Plate accept 1.0 mm selftapping bone screws and 1.2 mm emergency screws. Synthes Orbital Mesh Plates for the Midfacial System are provided nonsterile.

The DePuy Synthes 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.

The DePuy Synthes 2.4 mm Universal Locking Plate System plates are designed to accept the 2.4 mm – 3.0 mm diameter locking/non-locking screws.

The DePuy Synthes Mandibular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.

The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.

The provided document, K192655, is a 510(k) Premarket Notification for DePuy Synthes Maxillofacial Portfolio - MR Conditional. This type of submission is a declaration from the manufacturer to the FDA that their device is substantially equivalent to a legally marketed predicate device, and it does not typically involve clinical performance studies with acceptance criteria as one would find for novel AI/ML medical devices.

Instead, the provided document focuses on demonstrating MR Conditional safety for a portfolio of existing maxillofacial bone plates and screw systems that were previously cleared by the FDA. The "acceptance criteria" and "study" described herein relate to non-clinical electromagnetic compatibility (EMC) testing in an MR environment, not clinical performance for diagnostic or therapeutic accuracy of an AI/ML algorithm.

Therefore, the requested information elements related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's a breakdown of the information that is available and relevant to the document's purpose:

Acceptance Criteria and Study for MR Conditional Safety (Non-Clinical)

The submission aims to add "MR Conditional" labeling to a portfolio of maxillofacial devices. This requires demonstrating that the devices are safe for use in a specified MR environment under defined conditions. The "acceptance criteria" for this type of submission are typically based on recognized international consensus standards for testing the MR compatibility of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document consistently references the following ASTM standards for non-clinical testing to support MR Conditional safety across all listed devices:

Note: The document states that "Non-clinical testing is provided to support the conditional safety..." for each of these parameters. While it doesn't provide specific quantitative results (e.g., exact temperature rise in °C, or N/A for displacement/torque if deemed safe), the acceptance of the 510(k) by the FDA implies that the results of these tests met the predefined safety thresholds for an MR Conditional designation as per the referenced ASTM standards. The specific numerical results (e.g., maximum temperature rises, displacement forces, etc.) would be detailed in the full test reports submitted to the FDA, which are not part of this public summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: For non-clinical MR compatibility testing, the "sample size" refers to the number of device units tested. The document does not specify the exact number of physical devices or models tested for each parameter. However, standard practice for such assessments involves testing representative samples of each device type (plates, screws, meshes, distractors) and material compositions (titanium, titanium alloy) to ensure the portfolio's MR safety.
• Data Provenance: The data is "non-clinical testing" conducted by the manufacturer (Synthes - DePuy Synthes). The country of origin for the testing itself is not explicitly stated in this summary, but it would typically be conducted in a laboratory setting compliant with relevant international standards. This is retrospective in the sense that the studies were performed specifically to characterize the existing devices for MR compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable. This is a non-clinical evaluation of physical device properties in an MR environment, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" for MR safety is established by adherence to recognized ASTM testing standards and the physical properties of the materials and device in situ within the MR scanner, not by human expert consensus or annotations on medical data.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical testing of physical device characteristics, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The test results are objective measurements against standard-defined thresholds.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This submission is not for an AI-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This submission is not for an AI-powered device.

7. The Type of Ground Truth Used

• Physical Measurements against ASTM Standard Thresholds: The "ground truth" for MR Conditional safety is determined by rigorous physical measurements (e.g., temperature changes, displacement forces, torque, observable image artifacts) obtained through standardized testing protocols (ASTM F2052-14, F2213-06, F2182-11a, F2119-07) and comparison against acceptance limits defined by these standards or applicable regulatory guidance. It's about validating the device's behavior in an MR field, not diagnosing a condition. The "DUKE model" for RF heating indicates a high-fidelity computational human body model used for simulating temperature distributions due to RF fields.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set for AI/ML, this question doesn't apply.

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The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extraarticular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The DePuy Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically re-adaptation of torn or avulsed ligaments.

The DePuy Synthes 4.0 mm Titanium Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

The DePuy Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with DePuy Synthes Locking Plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm Conical Screws are intended to be used with existing DePuy Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the DePuy Synthes Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

DePuy Synthes 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

DePuy Synthes 6.5 mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

The DePuy Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the DePuy Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the DePuy Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis. The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis. The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, avulsions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula, and femur.

The DePuy Synthes Sterile 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions.

The 4.0 mm locking screws feature a self-tapping tip, are solid, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 62 mm. The threads just below the head of each locking screw engage with the threaded holes of the plate. The engagement of the screw to the plate shaft creates a locked fixed angle construct.

The DePuy Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 min increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.

The DePuy Synthes Spiked Washers are made of PEEK Optima™ LT plymer + 6% barium sulfate. There are either six or eight spikes arrayed around a center hole that will accommodate either 2.7, 3.5, 4.0, 4.5 or 6.6 mm screws.

The DePuy Synthes 4.0 mm Titanium (TI) Locking Screws feature a self-tapping tip, stardrive mechanishm, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 90 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP plating systems.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 – 145 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems

The DePuy Synthes Peri-Prosthetic Screws feature a self-tapping blunt tip, stardrive mechanism, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 12 mm. The threads on the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems.

The DePuy Synthes 3.5 mm Conical Screws are self-tapping, have a stardrive or hex drive recess, and are manufactured from stainless steel and titanium. The 3.5 mm conical screws are available in various lengths ranging from 40-95 mm.

The DePuy Synthes Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.

The DePuy Synthes 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.

The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is a solid metallic fixation bolt which is intended to be used in procedures involving the foot and ankle. The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is partially threaded on both ends and will be available in versions composed of implant quality stainless steel and titanium alloy.

The DePuy Synthes Cortical Screws have self-tapping features, stardrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any DePuy Synthes plate which accepts 1.0 mm, 1.3 mm, 2.0 mm, 2.4 mm, 2.7 mm, 4.0 mm, and 4.5 mm cortex screws. The screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.

The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

The DePuy Synthes 2.0 mm Quick Insertion Screws (QI Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to 18 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including (but not limited to) the radius, ulna, humerus, tibia, fibula and femur. The ALPS utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The locking feature consists of conical shaped, threaded screw holes in the plate that correspond wi th the conical-shaped, threaded head of the screw.

The 3.0 mm Cannulated Screw has a 3.0 mm thread diameter and a 4.0 mm head diameter. It is available in short and long thread lengths ranging from 10 mm to 40 mm. It features selfdrillinglself-tapping flutes and cancellous threads for use in cancellous bone. The screw is used in conjunction with a guide wire for precise placement in bone. The Threaded Washer has a 5.5 mm thread diameter and is 3.0 mm in length. It features exterior threads for bone purcbase in the near cortex and is cylindrically shaped to allow passage of the 3.0 mm Cannulated Screw. The washer serves to provide a buttress in the near cortex for which the screw head can compress against.

The DePuy Synthes Cannulated Angle Blade Plate is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate to reduce the surface area of the plate in contact with bone. The plate accepts 4.5 mm and 6.5 mm screws. he Cannulated Angle Blade Plate System is manufactured from stainless steel or commercially pure titanium.

This document describes the FDA's clearance of several DePuy Synthes trauma screws and plates as "MR Conditional" devices. The clearance is based on non-clinical testing demonstrating their safety in an MR environment, not on clinical performance or diagnostic accuracy. Therefore, the questions related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

Not applicable. The study was non-clinical (in-vitro) testing of the devices' physical properties in an MR environment, not a test set using human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" here is adherence to specific ASTM standards for MR safety, which are technical measurements rather than expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was non-clinical testing against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was compliance with established ASTM (American Society for Testing and Materials) standards for evaluating the MR safety of medical implants. These standards involve specific experimental setups and measurement methodologies to assess:

• Magnetically induced displacement force (ASTM F2052-14)
• Magnetically induced torque (ASTM F2213-06)
• Radiofrequency (RF) heating (ASTM F2182-11a)
• Image artifacts (ASTM F2119-07)

8. The sample size for the training set

Not applicable. This was non-clinical testing of physical devices. No training set for an algorithm was involved.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm was involved.

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The DePuy Synthes 2.4mm LCP Straight Wrist Plate is intended for Colles' and distal radius fractures with dorsal angulation of the distal fragment.

The 2.4mm LCP Straight Wrist Plate is designed for distal radius fractures with severe comminution requiring prolonged fixation, as an alternative to external fixation. Applied to the dorsal aspect of the wrist, the plate restores length and neutralizes loads on the consolidating fracture fragments.

The provided text describes a 510(k) premarket notification for a medical device, specifically the DePuy Synthes 2.4mm LCP Straight Wrist Plate. However, this document is a letter from the FDA regarding the substantial equivalence of a new version of an existing device (a sterile-packaged version) to an already cleared predicate device.

Crucially, this document states that "Clinical data was not necessary for the determination of substantial equivalence." This means that there was no clinical study, algorithm performance evaluation, or human reader study performed for this specific submission to demonstrate the device's efficacy or safety. The acceptance criteria and performance data typically requested for AI/ML-based medical devices or devices requiring clinical evidence are therefore not present in this document.

The "acceptance criteria" here refers to the FDA's regulatory criteria for determining substantial equivalence, not performance metrics of a device in a study. The "study that proves the device meets the acceptance criteria" in this context is the non-clinical performance testing that verifies the sterile packaging does not affect safety or performance, and the comparison to the predicate device.

Therefore, I cannot provide the detailed information requested in your prompt as it pertains to clinical performance and AI/ML model evaluation. The document specifically indicates that such data was not required for this particular submission.

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The DePuy Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The DePuy Synthes Titanium 2.4 mm Universal Locking Plates (12. 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum and promote fusion.

Contraindication: The DePuy Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:

DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:

• · Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
• · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of:

• · Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
• · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for the fixation, stabilization and reconstruction of:

• · Sternum fractures, fusions, and/or osteotomies
• · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.

Contraindications:

The MatrixRIB Fixation System is contraindicated for:

• · The fixation of the sternum in acute cardiac patients, due to the potential delay if emergent re-entry is required
• · Screw attachment or fixation to the clavicle or spine
• · Use in patients with latent or active infection, with sepsis, or who are unwilling or incapable of following postoperative care instructions.

The DePuy Synthes Sternal Fixation System consists of machined titanium plates, a quickrelease pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.

The proposed additions to the MatrixRlB Fixation System include sternal plates (straight plates, I-plates and T-plates) for fixation and reconstruction of the chest wall manufactured from commercially pure titanium (CP Ti Grade 4).

The previously cleared devices in the MatrixRlB Fixation System (K133616 and K081623) include locking plates, locking screws, and intramedullary splints for the fixation and stabilization of the chest wall for use in patients with normal or osteoporotic bone quality. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6A-7Nb).

The MatrixRIB Self-Drilling Screws (K190409) are available as locking screws, for permanent fixation, and non-locking screws, for temporary fixation only. The screws are provided in a range of lengths - locking screws: 13 lengths from 8mm to 20mm, with 1mm increments - and non-locking screws: 2 lengths from 10mm to 12 mm, with 2 mm increments. The major diameter of the bone thread is 2.7 mm, and all of the screws are manufactured from Titanium Alloy (Ti-6Al-7Nb).

The provided text describes the acceptance criteria and performance testing for two medical devices: the DePuy Synthes Sternal Fixation System - MR Conditional and the DePuy Synthes MatrixRIB Fixation System - MR Conditional. Both submissions aim to add MR Conditional information to existing device labeling, without changing the intended use or technological characteristics of the devices themselves.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the standard tests performed to demonstrate MR Conditional safety. The reported device performance is that the devices meet these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The provided text only mentions "non-clinical testing" and does not specify a sample size for a "test set" in the context of patient data. The tests are for the device itself (e.g., individual plates, screws) to assess its physical and magnetic properties. Therefore, the "sample size" would refer to the number of device components tested, which is not provided.

The data provenance is from non-clinical testing, meaning it's laboratory-based testing of the physical device components, not human patient data. There is no information regarding country of origin or whether it's retrospective or prospective, as these are typically applicable to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The ground truth for these tests is defined by the standards themselves (ASTM F2052-14, F2213-06, F2182-11a, F2119-07). The performance of the device against these standards is measured by engineers or technicians, not by medical experts establishing a clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. The testing described is objective, quantifiable physical testing against established international standards. There is no subjective interpretation or adjudication by multiple evaluators.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is non-clinical performance testing of the device's compatibility with an MR environment, not an evaluation of human reader performance or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This submission is for physical medical devices (sternal and MatrixRIB fixation systems), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on established independent engineering and safety standards (ASTM standards) for evaluating medical devices in Magnetic Resonance (MR) environments. These standards define the acceptable limits for magnetic displacement, torque, RF heating, and image artifacts.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is non-clinical physical testing of a medical device, not a machine learning model.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set. The "ground truth" for the device's MR compatibility is established by adherence to recognized ASTM standards.

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The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.

The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.

The DePuy Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards. The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.

The DePuy Synthes Sterilization Container System (K181933) is intended to enclose medical devices for sterilization and maintain their sterility for up to 180 days. The device uses dynamic air removal (pre-vacuum) steam sterilization. No clinical tests were performed, but extensive non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device, Synthes Reusable Sterilization Container System (K130720).

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates that testing was performed on "samples" of the device, container models, and worst-case configurations of joint reconstruction devices. Specific numerical sample sizes for each test are not explicitly provided. The data provenance is described as non-clinical testing performed by the manufacturer, DePuy Synthes. The studies are retrospective as they summarize verification and validation testing results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission is for a sterilization container system, and the evaluation is based on engineering and microbiological performance studies (non-clinical testing). Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiologist for imaging) is not directly applicable. The "truth" is established by adherence to recognized standards (e.g., ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, USP General Chapter <231> Heavy Metals) and objective measurements performed by qualified personnel in laboratories following Good Laboratory Practices (GLP), implied by the regulatory context.

4. Adjudication method for the test set

Not applicable, as this is a non-clinical device performance study based on objective measurements against scientific standards, not a diagnostic or interpretative study requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical device sterilization container, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical device sterilization container, not an AI-based algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests is based on:

• Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10⁻⁶ and 12 log reduction via biological indicators (BIs) (for sterilization efficacy and microbial challenge).
• Physical and Chemical Measurement Standards: Adherence to established standards for dry time, material properties (e.g., heavy metals leaching, cytotoxicity), and physical integrity (e.g., limits of reuse, package integrity).
• Industry and Regulatory Standards: Compliance with ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, and USP General Chapter <231> Heavy Metals.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable.

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The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction.

The DePuy Synthes Titanium Multi-Vector Distractor is intended for use in mandibular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts.

The DePuy Synthes Low Profile Neuro System - 3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediatric populations where gradual bone distraction is required.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: Maxillofacial surgery

The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity.

The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only. The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediatric CMF Distraction System is intended for single use only.

The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only.

The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation. for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The DePuy Synthes Curvilinear Distraction System is intended for single use only.

The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone.

The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.

The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.

The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The DePuy Synthes Cerclage Wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation.

This document is regarding the DePuy Synthes IMF Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes IMF Screws are designed with cross-axial through holes and a circumferential relief groove to accommodate wire or elastic bands. The IMF Screws are self-drilling, 2.0 mm in diameter, and available in thread lengths of 6mm to 12mm. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Titanium Multi-Vector Distractor, which are a supset of the DePuy Synthes Maxillofacial Portfolio-MR Conditional. The DePuy Synthes Titanium Multi-Vector Distractor (MVD) is a bone lengthening and distraction device that functions by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be accomplished with this device after distraction. The device is comprised of interchangeable distraction arms, various pin clamps, socket and hex head screws, rods, and activation nuts. All MVD pin clamps accommodate 2.0mm k-wires. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Low Profile Neuro System - 3 mm Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. Synthes ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes External Midface Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels. The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes 1.0/1.2 mm Craniofacial Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Alveolar Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Alveolar Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System), which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height system intended for use with DePuy Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation that is easily accessible with the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Modification to Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Orthodontic Bone Anchor (OBA) System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization. Screw Anchors: The screw anchor portion of the system consists of 1.55 nun self-drilling and selftapping screw anchors which incorporate a non-treaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor. The screw anchors are manufactured from titanium alloy (Ti-6A1-7Nb). Plate Anchors: The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mim cortex screws and 1.85 mma emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed)to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs. The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6A-7Nb). The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvillinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. The DePuy Synthes Curvilinear Distraction devices are manufactured from, titanium alloy and chromium cobalt alloy. Devices are supplied non-sterilized prior to use. The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components: Track: The track has grooves in Imm intervals which may be placed in a straight line (for a straight distractor) or on a centerline radius (for a curved distractor). The track is manufactured with a crimp that serves as a functional stop to prevent the distractor from separating at the end of the track is 35mm in length and can be cut to the desired length for each particular patient by the surgeon. After cutting, the track is crimped to re-establish the functional stop to prevent separation. Worm gear activation assembly: The worm activation assembly consists of the worm gear and a universal joint activation hex. The universal joint is capable of + or - 35 degree of angulation. The worm gear has a 1 mm pitch and rides along the grooves cut into the track. The worm gear activation assembly is inserted into the housing and the track with grooves is threaded through a slot in the side of the housing. Housing: The housing includes a tab that lays on the activation assembly to prevent the distractor from reversing due to micromotion. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Mandible Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or posttraumatic effects of the mandible, where gradual bone distraction is required. The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mrn or 2.4 mm bone screws. A hex driver is used to activate the required distraction. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes SMF Stainless Steel Bone Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The screws feature self-tapping tips and a cruciform drive recess. The screws are available in various lengths ranging from 4 to 38 mm. The longer screw lengths (24 - 38 mm) are specifically intended for symphyseal fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves over-drilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes 1.5 mm /2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes External Mandibular Fixator And/Or Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes External Multi Vector Mandible Distractor (MVMD), which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction. The DePuy Synthes External MVMD is comprised of two interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0mm k-wires. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0mm locking screws or standard 2.4 mm selftapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is regarding the DePuy Synthes Cerclage Wires, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Cerclage Wires are used to augment fracture stabilization with or without plates. The wire is available in a variety of diameters. The wires are pre-cut to a usable length or available in coils allowing the surgeon to cut the length to his patient's needs. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.

This document is focused on the MR Conditional labeling of a portfolio of DePuy Synthes Maxillofacial devices. The "acceptance criteria" discussed are related to MR safety, rather than diagnostic performance. The study described is a series of non-clinical tests to ensure the devices are safe for use in an MR environment.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported as meeting the conditional safety requirements for an MR environment. The acceptance criteria are implied by the standards cited for each test.

2. Sample Size Used for the Test Set and Data Provenance

The document consistently refers to "non-clinical testing" and the use of the "DUKE model" for RF heating. This indicates that the testing was performed on physical devices (samples) in a laboratory setting. No specific sample sizes for the devices themselves are given, as typically MR compatibility testing involves a representative sample of each device type/configuration. The data provenance is non-clinical laboratory testing. There is no mention of human subject data or data from a specific country of origin in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of study described. The testing is non-clinical, measuring physical properties and reactions of the devices in an MRI environment. Ground truth, in the sense of clinical interpretations by experts, is not established for this type of test. The "ground truth" for these tests would be the established scientific and engineering principles behind MR safety and the specified ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. The non-clinical testing involves objective measurements taken according to standardized protocols (ASTM standards), not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for MR Conditional labeling based on non-clinical safety testing, not for evaluating the diagnostic effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an AI/algorithm study. The document describes non-clinical testing of physical medical devices for MRI compatibility.

7. The Type of Ground Truth Used

The ground truth for this non-clinical study is based on:

• Scientific and engineering principles defined in ASTM standards: These standards (ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, ASTM F2119-07) define the acceptable limits for various MR safety parameters (e.g., displacement, torque, heating, artifacts).
• Physical measurements and observations from the laboratory testing of the devices.
• Anatomical modeling (DUKE model): For RF heating, the DUKE model is mentioned, indicating the use of a computational human body model to simulate heat distribution in a clinically relevant anatomical position.

8. The Sample Size for the Training Set

This information is not applicable. There is no training set mentioned, as this is not an AI/machine learning study.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set involved in this non-clinical MR safety testing.

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The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.

The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.

The provided text describes the 510(k) premarket notification for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio, focusing on their MR Conditional labeling. It primarily details non-clinical performance testing rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with human readers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion: The non-clinical performance data demonstrated that the subject devices, when exposed to the MR environment under specific MR conditions of use, did not raise new questions of safety or efficacy.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail a "test set" in the context of clinical or algorithmic performance. The testing described is non-clinical performance testing on the devices themselves to assess their safety in an MR environment. Therefore, information about human data provenance, sample size of a test set, etc., is not applicable to this type of study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. As this is non-clinical performance testing for MR safety, there is no "test set" that requires expert ground truth establishment in the traditional sense of medical image analysis or diagnosis. The "ground truth" here is the physical interaction of the device with the MR environment as measured by standardized tests.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" requiring adjudication by experts. The performance is measured against established engineering standards for MR safety.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document describes non-clinical performance testing for MR safety of physical implants and wires. It does not involve any AI, human readers, or a comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document describes non-clinical performance testing of physical medical devices, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established engineering and safety standards (ASTM standards) for assessing the behavior of medical devices in a Magnetic Resonance (MR) environment. This includes:

• ASTM F2052-14 for magnetically induced displacement force.
• ASTM F2213-06 for magnetically induced torque.
• ASTM F2182-11a for radio frequency (RF) heating.
• ASTM F2119-07 for image artifacts.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/algorithm study involving a training set. The descriptions are for non-clinical performance testing of physical devices.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an algorithm, there is no ground truth established in this context.

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The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula.

The DePuy Synthes Anatomical Locking Plate System indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur.

The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions.

The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.

The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions.

The DePuy Synthes Curved Reconstruction Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System.

The DePuy Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System.

The DePuy Synthes LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.

DePuy Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.

The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the distal humerus.

The DePuy Synthes Clavicle Hook Plate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, commninuted supra-condylar fractures, osteotomies, and non-unions of the distal humerus.

The DePuy Synthes LCP Proximal Humerus Plate, Long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions. The DePuy Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.

The DePuy Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.

The DePuy Synthes 3.5 mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

The DePuy Synthes 3.5 mm LCP Hook Plate is indicated for fractures, osteotomies and nonunions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 4.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The DePuy Synthes 3.5mm Locking Attachment Plate is intended for use with DePuy Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The DePuy Synthes 4.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes 3.5 mm LCP Clavicle Plate System is indicated for fixation of fractures, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically, Distal humerus plates are indicated for intra-articular fractures, commninuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures. malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.

The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, -The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and close-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia -The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures. and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia -The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur -The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions and malunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures: - Intra-articular fractures exiting the epiphysis - Intra-articular fractures exiting the metaphysis - Physeal crush injuries - Any injuries which cause growth arrest to the distal radius

The 3.5 mm Reconstruction Plate is available in multiple lengths. It has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole, and accept 3.5 mm cortex screws. The 4.5 mm Reconstruction Plate has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The oval holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole which allows 25° longitudinal and 7° lateral angulation of screws. It is available in multiple lengths and accepts 4.5 mm cortex and 6.5 mm cancellous screws. The 3.5 mm Curved Reconstruction Plate is available in multiple lengths. It has a smooth underside and is notched between screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole and accept 3.5 mm cortex screws.

The Anatomical Locking Plate System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the design of the holes in the plate. The screws are available in thread diameters from 3 mm to 5 mm, in a variety of lengths.

The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plat, and resultant reduction in damage-induced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform, which facilitate contouring. The plate has round and dynamic compression screw holes, accepts 4.5mm and 6.5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium.

The DePuy Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy.

The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium.

The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws.

The DePuy Synthes Curved Reconstruction Plate line extension is a pre-curved version of the currently marketed Straight Locking Reconstruction Plate. Both of these plates will be included as part of the DePuy Synthes Small Fragment DCL System. Both the curved and straight plates have the same intended use and there is no change in safety or efficacy.

The DePuy Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy.

The DePuy Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus. These plates can be applied to either the right or left humerus. The proximal portion of each plate has threaded holes that accept 3.5 mm or 2.7 mm screws. The distal portion of the plate has combination holes that allow the option of using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws to accomplish plate fixation. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System.

The DePuy Synthes Pilon Plate is a metal plate that offers screw to plate locking designed for various fracture modes of the distal end of the tibia.

The TomoFix™ Osteotomy System consists of five different titanium plates with locking and combination holes. There are two plates (left and right) for the lateral distal femur, 2 plates (left and right) for the lateral proximal tibia, and 1 plate for the medial proximal tibia.

The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm Broad LCP Distal Humerus Plates are contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate has dynamic compression holes combined with locking holes which accept 3.5 & 4.5 mm cortex, 3.5 & 4.5 mm self-tapping cortex, 3.5 mm shaft, 3.5,4.0, & 5.0 mm locking, and 4.0 mm cancellous screws. The plates are available in various lengths.

The DePuy Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).

The DePuy Synthes 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires.

The DePuy Synthes 3.5 mm LCP Distal Humerus System consists of medial and posterolateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes and conical locking holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium.

The DePuy Synthes LCP Proximal Humerus Plates, long are pre-contoured to match the anatomy of the proximal humerus with a limited contact low profile design. The plate features locking holes and combination locking and compression holes which accept 2.7, 3.5, & 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System.

The DePuy Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes.

The DePuy Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending.

The DePuy Synthes 3.5mm Spring Plate is a variation of the DePuy Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.

The DePuy Synthes 3.5 mm LCP Hook Plate is a low-profile, precontoured bone fixation plate intended for the treatment of fractures, osteotomies, and non-unions in small bones. The plates feature a preformed dual hook on one end and are available in stainless steel and titanium.

The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are low-profile, precontoured bone fixation plates intended for the treatment of fractures of the humerus. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.

The DePuy Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist on.5 mm LCP plates, 4.5 rom Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws.

The DePuy Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes to stabilize fractures. The plates are available in stainless steel and titanium.

The DePuy Synthes Curved Narrow and Broad LCP Plates are available in stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws.

The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are pre-contoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.

The DePuy Synthes 3.5 mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.

The DePuy Synthes Variable Angle LCP Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system: - -Medial Distal Humerus Plate - -Lateral Distal Humerus Plate - -Olecranon Plate - -Proximal Olecranon Plate Extra-articular Proximal Ulna Plate The system accepts existing conical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium.

The DePuy Synthes Variable Angle LCP Elbow System contains posterolateral and medial plates intended to treat fractures of the distal humerus. The plates are used together in a two-plate, 90° construct and accept existing screws. New 2.7mm Metaphyseal Screws are also compatible with the System.

The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium plate families with locking and combination locking/compression holes. This system features plates designed to provide stable fixation of osteotomies of the distal femur and proximal tibia. The DePuy Synthes TOMOFIX Medial Distal Femur Plates are part of the DePuy Synthes TOMOFIX Osteotomy System used for closed wedge femoral osteotomies. The subject plates are anatomically contoured to fit the medial distal femur, are available in right and left versions, as well as sterile and non-sterile.

The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will be available in stainless steel and titanium. The head of the plate will remain the same as the existing 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K102694) and will therefore allow the use of the existing guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will come in 3 different lengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodate different patient anatomy, the plate with 7 shaft holes will be available with three different plate head widths (Standard, Narrow and Wide). The 10 shaft hole and the 13 shaft hole plate will only be released with the Standard plate head width and additionally they feature a curvature in the shaft. All plates will feature left- and right-specific designs and will be offered in sterile packed only. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plates, Extra-Long are designed to accept existing 2.4mm Variable Angle Locking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VA Buttress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In the plate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mm Variable Angle Locking Screws, 2.7mm Variable Angle Locking Screws, 2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted.

The provided text describes several DePuy Synthes Trauma Orthopedic Plates and Screws that have received FDA 510(k) clearance (K180310) for "MR Conditional" labeling. The primary study presented for proving the device meets acceptance criteria is a series of non-clinical tests to assess the device's compatibility with the Magnetic Resonance (MR) environment.

Here's an organized breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for "MR Conditional" labeling are based on established ASTM (American Society for Testing and Materials) standards. The reported device performance is that the devices meet these standards.

Explanation: For each device covered under this 510(k) submission, the document explicitly states: "Non-clinical testing is provided to support the conditional safety of the [Device Name] in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy." This indicates that the devices met the requirements of these ASTM standards, thus satisfying the acceptance criteria for MR Conditional labeling.

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily refers to non-clinical testing. This type of testing typically involves physical device samples rather than human or animal subjects for evaluating MR compatibility. The document does not specify a numerical sample size for the devices tested for MR compatibility. The provenance is implied to be through laboratory testing under controlled conditions as per ASTM standards. There is no mention of country of origin of data in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For non-clinical testing of MR compatibility, the "ground truth" is typically established by the specifications of the ASTM standards themselves, interpreted and performed by testing engineers or technicians with expertise in medical device testing and MR safety. No specific number or qualifications of such experts are mentioned.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As the testing is non-clinical and based on quantitative ASTM standards, a human adjudication method (like 2+1, 3+1) is typically not applicable. The results would be objectively evaluated against the pass/fail criteria defined by the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The submission focuses on the "MR Conditional" status of the orthopedic plates and screws, which relates to their physical properties in an MR environment, not their diagnostic performance or how they impact human reader interpretation. Therefore, there is no mention of an effect size for human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The device is a physical orthopedic implant (plates and screws), not an algorithm or an AI-powered diagnostic tool. Therefore, there is no "standalone performance" of an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical MR compatibility testing is based on established testing standards (ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07). These standards define the methods and acceptance criteria for classifying a device as "MR Conditional."

8. The Sample Size for the Training Set:

Not applicable. As the tests are non-clinical, there is no "training set" in the context of machine learning or AI models. The testing involves physical samples under controlled conditions.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

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The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.

The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.

The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following. Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).

The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.

The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are designed to fit into the screw holes of existing DePuy Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation. The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.

The VA 5.0 Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0mm variable angle bone screws. Positioning or cerclage pins are intended for use with cerclage monofilament wire or multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.

The Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the wire mount hole above the outer surface of the plate, and then twisted with the opposite wire end.

The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.

This document describes the premarket notification (510(k)) for DePuy Synthes' MR Conditional Positioning Pins. The primary purpose of this submission is to add MR Conditional information to the device labeling, indicating that the devices are safe for use in an MR environment under specified conditions. The intended use and technological characteristics of the devices remain unchanged from their previously cleared versions.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are established by adherence to specific ASTM (American Society for Testing and Materials) standards for evaluating medical devices in Magnetic Resonance (MR) environments. The reported device performance indicates that the devices meet these standards, demonstrating safety under specified MR conditions.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for the test set. However, it indicates that testing was performed on "the subject devices" and "the construct" (referring to the device in combination with other materials/implants, where applicable). The data provenance is non-clinical, meaning the testing was conducted in a laboratory setting, not on human subjects. There is no information regarding the country of origin of the data. Given the context of a 510(k) submission to the FDA, it is highly likely these tests were conducted in the US or in a manner compliant with US regulatory requirements. The testing is prospective in the sense that the tests were designed and executed to evaluate the MR compatibility of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This submission relies on non-clinical testing and established ASTM standards. Therefore, there are no "experts" in the sense of medical professionals establishing a clinical ground truth for a test set. The "ground truth" is defined by the parameters and acceptance limits set forth in the ASTM standards themselves, which are developed by consensus among experts in the field of MR safety and material science.

4. Adjudication method for the test set:

Not applicable. This is not a human-reader study requiring adjudication of expert interpretations. The tests are physical measurements and observations against pre-defined ASTM standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for MR Conditional orthopedic implants, not an AI-assisted diagnostic tool. No MRMC study was performed as it is irrelevant to the device's function or regulatory pathway.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (orthopedic pin), not a software algorithm. The "standalone" performance refers to the inherent physical properties and behavior of the device in an MR environment, as detailed in the non-clinical testing.

7. The type of ground truth used:

The ground truth for this evaluation is defined by:

• Established ASTM Standards: These are industry-recognized protocols and acceptance criteria for evaluating MR safety. They represent a consensus on what constitutes acceptable performance for medical devices in an MR environment.
• Physical Measurements and Observations: The tests involved direct physical measurements (e.g., temperature, displacement, torque) and visual observations (e.g., image artifacts) of the devices under controlled MR conditions.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set. The performance is evaluated through material properties and physical testing.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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