Search Results

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.

Ask a specific question about this device

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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