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The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.

The provided text is a 510(k) Summary for the Bionx Implants Inc. Contour Labral Nail™. This document describes a medical device and its intended use, demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not present a study with acceptance criteria and device performance results in the way requested in the prompt (e.g., in the context of AI/software performance).

The request asks for information typically found in a clinical or performance study report for a diagnostic device or AI algorithm, particularly points related to ground truth, expert review, sample sizes for training/test sets, and comparative effectiveness studies.

Since the provided document is a 510(k) summary for a physical medical implant (a biodegradable soft tissue fixation fastener), these specific types of studies and acceptance criteria are not applicable or present in the text. The basis for clearance is demonstrating "substantial equivalence" to existing cleared devices, rather than a performance study meeting specific statistical criteria for accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill the request as stated with the provided input.

However, based on the principle of substantial equivalence, the "acceptance criteria" can be inferred as demonstration of similar characteristics and performance to the predicate device.

Here's how the information in the document relates to the prompt, albeit with caveats due to the nature of the device:

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

• Acceptance Criteria (Inferred from Substantial Equivalence): The device must have "the same intended use, similar principles of operation and technological characteristics" as the predicate devices, and "the minor technological differences... do not raise any new issues of safety or effectiveness."
• Reported Device Performance: The document does not provide quantitative performance metrics (e.g., success rates, complication rates) for the Contour Labral Nail™. Substantial equivalence is the basis for its clearance, implying its performance is expected to be similar to the predicate devices which are already on the market.

2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study testing an algorithm on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/diagnostic algorithm for this physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical implant, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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