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Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray.

The document is a 510(k) Summary for the Oxford® Fixed Lateral Bearing Partial Knee Replacement, seeking substantial equivalence to a previously cleared device (K122277). The modification is a design change to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance measures. Instead, the "performance data" section focuses on demonstrating substantial equivalence through non-clinical testing. The conclusion reached is that the subject construct is "substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness."

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

The document states "Non-clinical performance testing included cadaver evaluation and MRI justification."

• Sample Size for Test Set: Not explicitly stated as a number of samples or subjects. It only mentions "cadaver evaluation," implying a limited set of cadaver knees were used.
• Data Provenance: The cadaver evaluation would be considered prospective data collection for the specific purpose of this evaluation. The country of origin for the cadavers is not specified. MRI justification likely refers to engineering analysis or imaging studies to demonstrate the design change.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given it's a cadaver evaluation for a mechanical device modification, formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been employed in the same way they would for diagnostic imaging studies. The evaluation would likely have been conducted by biomechanical engineers or orthopedic surgeons.

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

• MRMC Study Done? No. The product is a knee implant, not a diagnostic imaging AI algorithm that would typically undergo MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not applicable. This is a physical medical device (knee implant), not an AI algorithm. The performance evaluation focuses on the mechanical and functional aspects of the implant itself, primarily through non-clinical testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device modification is established through physical and mechanical evaluation (cadaver evaluation), engineering justification, and comparison to the safety and effectiveness profile of the legally marketed predicate device. The goal is to show the modified device functions as intended without introducing new safety or effectiveness concerns, akin to demonstrating physical equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the design comes from extensive biomechanical and materials science knowledge, as well as experience with the predicate device.

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

• How Ground Truth for Training Was Established: Not applicable. See point 8. The design process for a physical device relies on established engineering principles, material properties, biomechanical considerations, and clinical experience with similar devices, rather than a "ground truth" derived from a specific "training set" of data.

In summary: This document pertains to a 510(k) submission for a physical medical device (a knee implant modification), not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components relevant to AI/software performance (like human reader studies, training/test sets, expert adjudication for image interpretation) are not applicable or described in this type of submission. The focus is on demonstrating "substantial equivalence" through non-clinical (cadaver and engineering) testing to a predicate device.

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