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The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:

2. inflammatory degenerative joint disease including rheumatoid arthritis;

3. correction of functional deformity:

4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Hinge Knee System implants are for cemented use only.

The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:

• a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
• a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
• a yoke extension stop offered in 3 options (0°, 5°, 10°)
• a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
• a tibial base offered in two variants:
  • modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
  • monolithic (3 sizes, 1-3) with fixed small keel o
• . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
• Universal femoral augments
  • distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
  • posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
• Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses

Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.

The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.

The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a knee system, primarily discussing its substantial equivalence to previously marketed devices based on non-clinical testing, design features, and materials.

It explicitly states:

• "Clinical data were not provided for the subject device." (Page 7, Section E. Clinical Testing)

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on mechanical and material testing, and substantial equivalence, not a clinical study involving an AI or diagnostic device with acceptance criteria for performance metrics like sensitivity or specificity.

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The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only

The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

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