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The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

These devices are single-use implants intended for implantation with bone cement.

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).

The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) summary for a knee implant, which in many cases, especially for predicate devices, relies heavily on substantial equivalence to already approved devices rather than new clinical trials demonstrating performance against specific clinical acceptance criteria. The information you're asking for (e.g., acceptance criteria, test set details, expert qualifications, HRMC studies) is typically found in the clinical study reports for devices that require extensive new clinical evidence, often for novel devices or those with higher risk classifications.

Based on the provided text, the device is being cleared based on substantial equivalence, meaning it's demonstrated to be as safe and effective as a legally marketed predicate device. This often involves non-clinical testing (e.g., mechanical, materials) and comparison of design and indications for use, rather than extensive human clinical trials with performance metrics.

Analysis of Acceptance Criteria and Study for K063515

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance in the clinical sense are not explicitly stated in terms of specific sensitivity, specificity, accuracy, or similar clinical metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as its predicates.

The "study that proves the device meets the acceptance criteria" largely relies on non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a human clinical test set. The evaluation primarily involved non-clinical laboratory testing.
• Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed in a laboratory setting, likely at Biomet or a contracted facility.

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

• This information is not provided because the submission did not involve a clinical study requiring expert ground truth for a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing would be measured physical properties and performance against established engineering standards or predicate device benchmarks.

4. Adjudication Method for the Test Set

• Not applicable as there was no human clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical Testing: None provided as a basis for substantial equivalence."
• Therefore, there is no effect size reported for human readers with or without AI assistance.

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

• Not applicable. This device is a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" would be established engineering specifications, material properties (e.g., tensile strength, fatigue life), and performance metrics (e.g., wear testing, load bearing capacity) as defined by relevant ISO or ASTM standards, and comparative data from the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the new device itself in a clinical context.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable, as there was no training set in the context of machine learning.

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