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Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System 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 or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
   These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

• Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
  When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.

The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.

This document is a 510(k) premarket notification for a medical device called "MAK OSS Femoral Knee Components." It focuses on design modifications to a locking pin within the existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set used in the non-clinical testing. It only states that "Verification testing was conducted."

The data provenance is not explicitly mentioned (e.g., country of origin). Since this is a 510(k) submission to the FDA, it can be inferred that the testing and data generation occurred within a context relevant to US regulatory standards, likely in the US or by a US-based or affiliated entity. The testing was non-clinical, involving mechanical tests, not human subjects.

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

This document describes non-clinical, mechanical testing. Therefore, there were no human experts establishing a "ground truth" in the clinical sense (e.g., diagnosis, outcome assessment). The "ground truth" for this engineering verification would be the objective measurements of insertion and extraction forces against predefined engineering specifications or benchmarks for the predicate device. The experts involved would be biomechanical engineers or test technicians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical testing against engineering specifications, not a study involving human interpretation or subjective assessments that would require adjudication.

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

Not applicable. This is a 510(k) submission for a mechanical medical device (femoral knee components) and does not involve AI, human readers, or image interpretation.

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

Not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on objective engineering measurements of insertion and extraction forces, compared against predefined specifications or performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The term "training set" is generally used in the context of supervised learning, where an algorithm learns from labeled data.

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

Not applicable, as there is no "training set" for this mechanical device.

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