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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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Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.

The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.

Here's an analysis of the provided text regarding the Stryker Temporary Condylar Prosthesis, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study:

The provided document describes a 510(k) submission for a modification to the Stryker Temporary Condylar Prosthesis. The modification is a change in the material composition of the coating used on the head of the prosthesis. The study performed aims to demonstrate substantial equivalence to the previously cleared predicate device (K020199) by proving that this change in coating material does not adversely affect the safety and effectiveness of the device.

The study employed a series of Verification and Validation testing focused specifically on the new coating material and its impact on the device's overall performance.

2. Sample Sizes Used and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of tests conducted per device) used for the friction, roughness, thickness, wear resistance, adhesion strength, hardness, biocompatibility, and corrosion tests. It generally states that "Various tests... were conducted."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a device modification, these studies are typically internal validation tests performed by the manufacturer (Stryker Leibinger GmbH & Co. KG, Germany) or their contracted labs, and are prospective in nature for the modified component.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• The document describes engineering and laboratory tests (friction, wear, biocompatibility, etc.), not clinical studies requiring expert ground truth or diagnoses. Therefore, the concept of "experts establishing ground truth" in the medical diagnostic sense is not applicable here. The "ground truth" for these tests would be established by validated test methodologies and acceptance criteria for mechanical and material properties.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human observers or diagnoses. This document describes laboratory verification and validation testing. Therefore, such adjudication methods are not applicable. The assessment of test results would be based on comparison against predefined engineering specifications and standards.

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

• No MRMC study was done. This document describes a submission for a modified medical device focusing on material properties and performance. MRMC studies are typically conducted for diagnostic devices (e.g., AI algorithms for image analysis) to assess the impact of AI assistance on human reader performance. This is not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study was done. This is not a software algorithm or AI-powered device. Its performance is assessed through physical and chemical testing of the material and mechanical design.

7. Type of Ground Truth Used

• For the performance testing, the "ground truth" was based on engineering specifications, material science standards, and predefined acceptance criteria for mechanical, chemical, and biological properties. For example, a "ground truth" for wear resistance would be a maximum allowable wear rate as defined by relevant standards or internal specifications, against which the test results are compared. For biocompatibility, it would be compliance with ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set." The development process would involve iterative design, prototyping, and testing, but not a data-driven training set in the AI sense.

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.

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