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KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin personnel during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

This document describes the 510(k) summary for the KLS Martin IPS Distraction device. It provides information regarding the device's indications for use, technological characteristics, and a comparison to predicate and reference devices to support a claim of substantial equivalence.

Based on the provided text, the device in question is a medical implant (bone plates) designed for cranial and facial bone distraction. Therefore, the acceptance criteria and study proving its performance will relate to its mechanical properties, biocompatibility, sterilization, software validation, and clinical safety and effectiveness for its intended patient population.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and their outcomes in narrative form to demonstrate substantial equivalence. I will infer the "acceptance criteria" from the types of tests conducted and the "reported device performance" from the stated results.

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

• Mechanical Testing (Weld Strength): The document does not specify the exact sample size for the weld strength test. It states "A direct comparison weld strength test was performed," implying sufficient samples for a comparative analysis, but no number is given.
• Biocompatibility, Sterilization, Pyrogenicity: These tests leveraged data from a previously cleared device (K191028). No new sample sizes are explicitly mentioned for these, as the substantial equivalence hinges on the similarity to the already-tested reference device. If new samples were tested for verification, their numbers are not stated.
• Software V&V: No specific sample size (e.g., number of cases or simulations) is mentioned for software testing. It refers to "all software requirements and specifications" and "on-site user acceptance testing."
• Clinical Performance (Pediatric): 5 clinical studies were analyzed to support the pediatric indications. The document lists the studies, but does not state how many patients were in the "test set" for the KLS Martin device specifically. These appear to be literature reviews, not new clinical trials conducted for this device clearance.
  • Data Provenance: The provenance of the data for the 5 analyzed clinical studies is implied to be from published literature ("Based on published literature findings"). Specific country of origin is not mentioned, nor is whether the studies were retrospective or prospective, though typical clinical trials are prospective, and reviews can be of either.

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

• Mechanical, Biocompatibility, Sterilization, Pyrogenicity, Software V&V: The document does not mention the use of external "experts" to establish ground truth for these non-clinical performance tests. These are typically assessed against pre-defined engineering and biological standards by internal or contract testing labs.
• Clinical Performance (Pediatric): The "ground truth" for the pediatric clinical performance is based on "published literature findings" and risk assessments performed based on FDA guidance. There is no mention of a specific number of experts used to establish a new ground truth for this 510(k) submission's test set. The experts are implicitly the authors of the peer-reviewed clinical literature analyzed and the regulatory/clinical affairs personnel conducting the risk assessment. Qualifications of these implied experts are not detailed in this document.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is described for any of the tests, as these are technical performance tests or literature reviews, not studies involving human interpretation of medical images or data requiring reader consensus.

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 MRMC comparative effectiveness study was mentioned or performed. This device is a passive implantable device, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a surgical implant, not a software algorithm. The software mentioned (for planning and design) is a tool for manufacturing patient-specific implants, not a diagnostic algorithm in itself that would have standalone performance.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is implicitly defined by engineering standards for tensile strength and material properties.
• Biocompatibility: Ground truth is established by the accepted international standard ISO 10993 series.
• Sterilization: Ground truth is defined by the accepted international standard ISO 17665-1:2006 and a target SAL of 10^-6.
• Pyrogenicity: Ground truth is defined by AAMI ANSI ST72:2019 and USP allowed limits for endotoxins.
• Software V&V: Ground truth is established by pre-defined software requirements, specifications, and risk assessment outcomes.
• Clinical Performance (Pediatric): Ground truth for the safety and effectiveness in pediatric applications is based on peer-reviewed clinical literature and FDA guidance on pediatric medical devices, interpreted through a risk assessment. This is a form of outcomes data and expert consensus derived from previous studies, rather than a new "ground truth" adjudicated for this submission.

8. The Sample Size for the Training Set

• This question is not applicable to an implantable device like KLS Martin IPS Distraction. "Training set" usually refers to data used to train a machine learning algorithm.
• For the patient-specific design, the "training" data is the individual patient's CT scan. Each device's design is unique to the patient's anatomy. The "training" for the process comes from accumulated experience, validated software, and adherence to design specifications described in the section about patient-specific manufacturing.

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

• This question is not applicable for the reasons stated above. For the individual patient design process, the "ground truth" (the patient's anatomy for which the device is being designed) is established directly from the patient's CT scan data. The "virtual planning" involves interactions between the physician and trained KLS Martin personnel to refine the design, with "verification" performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure adequate fit.

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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 Stryker Pediatric Mandibular Distractor 2 is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandibular Distractor 2 is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.

The Stryker Pediatric Mandibular Distractor 2 (PMD 2) system is a distraction system consisting of the following major components: distractor with integrated footplates, integrated anti-reverse feature, removable activation rod, deactivation instrument, and a small activation handle/activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external small activation handle/activation key used to initiate the distraction of the bone segments. The anti-reverse feature is deactivated with the corresponding deactivation instrument.

The Stryker Pediatric Mandibular Distractor 2 (subject device) includes the distractor body. integrated footplates, a sliding footplate, integrated anti-reverse feature, and the activation joint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm) and right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.

The provided text describes the regulatory clearance of the Stryker Pediatric Mandibular Distractor 2 (PMD 2) and highlights its acceptance criteria through various non-clinical tests. However, it does not include information about a study involving human readers, AI assistance, or the specifics of ground truth establishment for such a study. This is a medical device approval document, not an AI/ML algorithm validation report.

Therefore, many of the requested fields cannot be filled.

Here's the information that can be extracted:

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

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

The document describes non-clinical (bench) testing, not a clinical study with a "test set" of patients or data in the typical sense. Therefore, "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable to these engineering/materials performance tests. The tests were performed on the device itself and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes physical and material performance tests for a medical device, not a diagnostic or prognostic algorithm requiring expert-established ground truth from images or clinical data.

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

Not applicable. Adjudication methods are relevant for interpretation of clinical or imaging data, not for these types of engineering performance tests.

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 such study was conducted or mentioned. This document pertains to a physical medical device.

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

Not applicable. This is not an AI/ML algorithm.

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

For the non-clinical tests described, the "ground truth" would be the established scientific and engineering principles, international standards (e.g., ISO, ASTM), and internal company specifications for material properties, mechanical performance, and biocompatibility. The tests verify that the device meets these predefined objective standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. This is not an AI/ML algorithm.

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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 mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.

Mandible

• The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months
• The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
• The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below.

The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument either percutaneously or intra-orally.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.

The provided document is a 510(k) premarket notification for a medical device called the "Craniomaxillofacial Distraction System (CMFD)". This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than on proving the device meets specific performance acceptance criteria through the rigorous study design you've outlined in your request.

Here's why the text doesn't contain the information you're asking for:

• Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by demonstrating similar technological characteristics, indications for use, and by performing non-clinical testing that shows comparable performance.
• Lack of Clinical Performance Data: Section 5.8 explicitly states: "No clinical performance data is included in this submission." This means there isn't a human clinical study with a test set, ground truth experts, adjudication methods, or MRMC studies.
• Non-Clinical Data: The "Non-clinical performance data" section (5.7) describes engineering and in-vitro tests (e.g., bending strength, torque input/force output, tensile strength, biocompatibility, sterilization) to address the recall issue and support equivalence. These are not the type of studies that would establish the specific acceptance criteria for a "device performance" metric in the way you've described (e.g., accuracy, sensitivity, specificity, etc., typically associated with AI/diagnostic devices).
• No "Acceptance Criteria" Table: The document doesn't present a formalized table of acceptance criteria for diagnostic or performance metrics because it's not a performance study for a novel device, but rather a submission for a modification to an existing one to address a recall.

Therefore, I cannot extract the information for your table (acceptance criteria, reported device performance), nor can I answer your specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to a clinical performance study. The document describes engineering tests and comparisons to a predicate, not the kind of clinical validation study you're asking about.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis) and mid-face bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of the mandible and mid-face bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document describes a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by indicating that the new device is a sterile version of existing non-sterile devices.

Based on the provided document, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study. Instead, it describes general design requirements and performance evaluations for mechanical properties and biocompatibility. The "reported device performance" indicates that these requirements were met.

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

• Sample size for the test set: Not applicable (N/A). This submission did not involve a clinical study with a "test set" of patients. The performance data presented is from non-clinical bench testing and biocompatibility assessments of the device materials.
• Data provenance: N/A. The data provenance described is related to bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of experts: N/A. No clinical test set with ground truth established by experts was used.

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

• Adjudication method: N/A. No clinical test set to adjudicate was utilized.

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

• MRMC study done: No. This is a medical device (bone plate/distractor) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study would not be relevant in this context.
• Effect size: N/A.

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

• Standalone done: No. This submission is for a physical medical device.

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

• Type of ground truth: N/A. For the mechanical and biocompatibility testing, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., design requirements, ANSI/AAMI ST72:2011, USP , EP 2.6.14 for endotoxins). No clinical ground truth (like expert consensus or pathology) was used as there was no clinical study.

8. The sample size for the training set

• Sample size for the training set: N/A. There was no "training set" in the context of an algorithm or AI. The design and manufacturing processes for the device are well-established based on existing predicate devices.

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

• How ground truth was established for the training set: N/A. This concept is not applicable to the type of device and submission described.

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The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.

This document is a 510(k) premarket notification for a medical device called the "Mandible External Fixator - MR Conditional." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly regarding its MRI compatibility.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document doesn't present a formal table of acceptance criteria with specific numerical thresholds for general device performance. Instead, it describes the acceptance criteria implicitly through the non-clinical tests performed for MR Conditional labeling. The "reported device performance" is then stated as successfully meeting the requirements of these tests.

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

The document states, "Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts."

• Sample size: The document does not specify the sample size used for these non-clinical tests. It implies that the tests were performed on representative samples of the Mandible External Fixator components.
• Data provenance: The data is non-clinical performance data (laboratory testing) conducted to support the MR Conditional labeling. The country of origin of the data is not explicitly stated, but as the submitter is "Synthes USA Products, LLC" in "West Chester, PA, United States of America," it is likely that the testing was performed in the United States or at facilities supporting their US operations. The data is not retrospective or prospective clinical data as no clinical testing was performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this submission. The "ground truth" for non-clinical MR Conditional testing is based on established industry standards and regulatory guidance for evaluating the safety of devices in an MRI environment (e.g., ASTM standards for MR safety). It does not involve expert consensus on medical images or clinical outcomes. Therefore, no experts were used to establish ground truth in this context.

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

This question is not applicable as the evaluation of MR safety testing results does not involve human adjudication in the way clinical diagnostic studies might. The results are typically objectively measured and compared against predefined safety 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (Mandible External Fixator) and focuses on its material properties and safety in an MRI environment, not on diagnostic image interpretation or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical fixator, not an AI algorithm.

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

The "ground truth" for the non-clinical MR Conditional evaluation is based on established scientific principles, engineering standards (e.g., ASTM F2503 for MR Conditional labeling), and regulatory guidance concerning the interaction of materials with magnetic fields, radiofrequency energy, and their impact on image quality. It's an objective measurement against defined safety limits, not a subjective assessment by medical experts or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. Since no AI algorithm is involved, there is no "training set." The testing performed was non-clinical and focused on the physical device's characteristics.

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

This question is not applicable as there was no training set since no AI algorithm was developed or evaluated.

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The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.

The Pediatric Mandible Distractor (PMD) System is a distraction system consisting of the following major components: distractor with integrated footplates, a removable activation rod and an activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external activation key used to initiate the distraction of the bone segments.

The Pediatric Mandible Distractor (Subject Device) includes the distractor body. integrated footblates, a sliding footblate, and the activation ioint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm), right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.

The Stryker Pediatric Mandible Distractor received 510(k) clearance based on non-clinical performance testing. No clinical testing was performed.

Here's an overview of the acceptance criteria and the study that proves the device meets them:

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

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

This information is not provided in the document. The testing was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed and therefore no expert-established ground truth on patient data was required. Acceptance criteria were based on recognized engineering and material standards or internally predetermined criteria.

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

Not applicable, as no clinical testing involving human reviewers or adjudication of cases was performed.

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, as this device is a physical medical implant and not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable, as this device is a physical medical implant, not an algorithm.

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

The "ground truth" for the non-clinical testing was defined by the specific requirements and limits set forth in the referenced ISO or ASTM standards, or by internally predetermined acceptance criteria when no external standards were applicable. This type of ground truth can be characterized as:

• Standard-based performance metrics: For categories like biocompatibility, bench testing, and sterility, the device's performance was compared against the objective, quantifiable requirements and limits specified in applicable international (ISO) and American (ASTM) standards.
• Engineering specifications/Internal criteria: For other categories (cleaning validation, corrosion, simulated aging, residual moisture, handling), the device was evaluated against internally predetermined specifications and criteria. These likely originated from engineering design requirements, risk assessments, and manufacturing specifications.

8. The sample size for the training set

Not applicable, as this device is a physical medical implant, not an AI model requiring a training set.

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

Not applicable, as no training set was used for this physical medical device.

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The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The 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 Synthes Curvilinear Distraction System is intended for single use only.

The 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 Curvilinear 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. Synthes Curvilinear Distraction System devices are manufactured from titanium alloy and chromium cobalt alloy. Devices are supplied non-sterile and must be 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, Worm gear activation assembly, and Housing.

Acceptance Criteria and Device Performance Study for Synthes Curvilinear Distraction System (K121502)

This report details the acceptance criteria and the study that proves the Synthes Curvilinear Distraction System meets these criteria, based on the provided 510(k) summary (K121502).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The performance data is derived from non-clinical mechanical testing.

• Sample Size for Test Set: Not applicable as a clinical test set was not used. The mechanical testing involved specific test articles (Synthes Curvilinear Distraction System, specifically the 1.3 mm Curvilinear Distractor). The exact number of units tested for each mechanical test is not specified in this summary.
• Data Provenance: The data is from non-clinical mechanical testing conducted by Synthes (USA), a company located in West Chester, PA, United States of America.

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

Not applicable. Since clinical testing was not performed and performance was evaluated through mechanical testing, there was no ground truth established by human experts for a clinical test set. The "ground truth" for the mechanical tests would be the established engineering standards and physical properties for medical devices of this type, as measured by standard laboratory equipment and procedures.

4. Adjudication Method for the Test Set

Not applicable. As stated above, clinical testing with a human-in-the-loop component was not conducted, rendering an adjudication method unnecessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no assessment of human readers' improvement with or without AI assistance was conducted.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a mechanical distraction system, not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used for Performance Evaluation

The ground truth used for evaluating the performance of the Synthes Curvilinear Distraction System was based on:

• Established engineering standards and benchmarks for mechanical strength (four-point bend testing) to demonstrate the ability to withstand mastication forces and resist permanent deformation.
• Physiological requirements and existing clinical understanding of anatomical resistance to distraction, which served as the basis for the acceptance criterion for the torque-force testing.
• ASTM standards for material composition and biocompatibility.

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this device is a mechanical system and does not involve machine learning or AI that requires training data.

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

Not applicable. As there was no training set, there was no ground truth established for it.

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Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the MIS Crest Widener, addressing your requested information:

Summary of Acceptance Criteria and Device Performance (based on the provided document):

The provided 510(k) summary for the MIS Crest Widener does not contain specific quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., success rates, bone growth measurement).

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" being evaluated and asserted is primarily in terms of:

• Intended Use: The device shares the same intended use as its predicate devices: "Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation."
• Technological Characteristics: The device is made of similar materials (Titanium alloy complying with ASTM F136-02), has a similar mechanism of action (distraction osteogenesis via screw activation), and a similar duration of placement.

Therefore, the "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device performs as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness.

Key Missing Information:

It's crucial to note that the provided 510(k) summary does not include any clinical study data or performance metrics that would typically be found in a study proving a device meets specific acceptance criteria. This type of submission relies on the established safety and effectiveness of the predicate devices.

Given this, I cannot fill in precise quantitative values for acceptance criteria or device performance as they are not present in the document.

Detailed Breakdown of Your Requested Information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document does not describe a clinical study with a "test set" of patients or data to evaluate the device's performance. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo clinical performance data.
• Data Provenance: Not applicable, as no dedicated test set data is presented.

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

• Not applicable. As there is no clinical test set described, there is no mention of experts establishing ground truth for such a set. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices, as deemed by prior FDA clearances.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set or data analysis requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Not applicable. This device is a manual surgical instrument and does not involve any algorithms or standalone software performance.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the documented performance, safety profile, and regulatory history of the legally marketed predicate devices. The new device asserts equivalence to these established devices. This is not "expert consensus," "pathology," or "outcomes data" specifically generated for the MIS Crest Widener, but rather the established understanding of the predicates.

8. The Sample Size for the Training Set

• Not applicable. This device is a manual surgical instrument and does not involve machine learning algorithms that require a "training set" of data.

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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The Distrax is intended for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis. Following the distraction osteogenesis, the Distrax may also be used for temporary stabilization during the consolidation phase. The Distrax is intended for single patient use only.

Distrax™ is a preassembled distraction system consisting of the following major components: Distraction Screw, Distractor Arms, Fixed Screw, Threaded Tube, Locknut (optional). Titanium Bone Screws (K063298) and brackets (surgical stainless steel, 24 gauge) are required for use and should be obtained by the surgeon and orthodontist, respectively. An Activation Key is also supplied to turn the Distraction Screw. The patient contact materials of the Distrax are made of austenitic stainless steel type 304 (chromium-nickel stainless class) and type 316 (chromium-nickel class containing 2-3% molybdenum). These materials are specified in ISO standards 5832-1 and 5832-9 for medical implant applications. The device must be cleaned and sterilized before use.

The provided text is a 510(k) summary for the Distrax™ device. It doesn't contain information about specific acceptance criteria or the study that proves the device meets those criteria in the traditional sense of a performance study with quantitative results.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Modus Modular Distraction Osteogenesis System - K051946). This means the device is considered safe and effective because it is similar in intended use, materials, design, and operating principles to a device already legally marketed.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from this document.

Here's how to address the request based on the provided text:

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

This information is not provided in the 510(k) summary. The acceptance criteria for substantial equivalence are based on demonstrating similarity to a predicate device, not on specific quantitative performance metrics tested in a clinical trial.

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

Not applicable. This is not a study that involved a "test set" of patient data for performance evaluation in the way implied by the question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment for a patient test set is not part of a substantial equivalence determination based on device design and materials.

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

Not applicable. This is not a study that involved adjudication of performance on a test set.

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. MRMC studies are typically for diagnostic or interpretive devices, often involving AI. This device is a surgical implant for distraction osteogenesis.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Modus Modular Distraction Osteogenesis System - K051946) to which Distrax™ is substantially equivalent.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of the basis for acceptance:

The Distrax™ device was accepted based on its substantial equivalence to the predicate device, the Modus Modular Distraction Osteogenesis System (K051946). This equivalence was established by demonstrating similarities in:

• Intended Use: Both devices are for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis, and temporary stabilization during the consolidation phase.
• Materials: Both use stainless steel (Distrax specifies austenitic stainless steel types 304 and 316, compliant with ISO standards). The predicate also mentions implant steel and titanium.
• Design: While Distrax is preassembled and customized, and the Modus is modular, both serve the function of distraction.
• Operational Principles: Both operate on the principle of gradual bone distraction osteogenesis.
• Sterilization: Both are supplied non-sterile with instructions for sterilization.
• Single Use: Distrax is single-use; the predicate's single-use status is not known from the document.

The FDA reviewed the submission and determined that Distrax™ is substantially equivalent to the predicate device for its stated indications for use. This means the device meets the regulatory requirements for marketing based on its similarity to an already approved device, without requiring a new clinical performance study with specific quantitative acceptance criteria.

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