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Biomet's OSS Knee System is intended for use in total knee replacement. Specific indications for these devices are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies
5. Tumor resections
6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
7. Revision of previously failed total joint arthroplasty
8. Trauma
   These devices are to be used with bone cement

There are two styles of MAK OSS Knee Femoral components, resurfacing and segmental. They have a plasma spray porous coating on the distal bone/implant interface surface and the articular surfaces have a color buff surface and two holes in the posterior condyles accommodate the femoral bushings and axle that connect the femoral component to the tibial component to create a hinged knee.
A polyethylene hyperextension bumper component fits into a pocket between the femoral condyles at the time of surgery. The bumper limits the amount of extension allowed by the implant.

This 510(k) premarket notification for the "MAK OSS Knee Femoral Components" indicates that it is a medical device for total knee replacement. The review explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted for this device to prove it meets specific acceptance criteria based on human or AI performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details. The submission relies solely on non-clinical laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an explanation of what can and cannot be provided based on the given text:

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

• Cannot be provided. The document states "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This refers to mechanical or material testing, not performance against clinical acceptance criteria. No specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are mentioned for human or AI performance.

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

• Cannot be provided. No clinical test set was used for human or AI performance evaluation.

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):

• Cannot be provided. No clinical test set requiring expert ground truth was utilized.

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

• Cannot be provided. No clinical test set requiring adjudication 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:

• Cannot be provided. No MRMC study was conducted, as no clinical testing was performed. The device is a physical knee implant, not an AI-assisted diagnostic tool.

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

• Cannot be provided. This device is a physical knee femoral component, not an algorithm, so standalone algorithm performance is not applicable.

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

• Cannot be provided. No clinical ground truth was established as no clinical testing was performed.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm was used, as this is a physical medical device.

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

• Cannot be provided. Not applicable as no training set for an algorithm was used.

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