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The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:

Hip
• Acetabular labrum repair/reconstruction

Shoulder

• · Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Rotator cuff tear repairs
• Bicepts tenodesis

The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.

This document is a 510(k) premarket notification for a medical device, specifically the Smith & Nephew SUTUREFIX Curved Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this type of regulatory submission. The document states that performance data exists, but does not provide the specifics of those studies.

Here's a breakdown of the available information based on your request:

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

Note: The specific numerical acceptance criteria and reported values for insertion and pull-out strength are not provided in this summary.

2. Sample sized used for the test set and the data provenance

Not provided in this document. The document mentions "Performance data demonstrates," but does not specify the sample sizes or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. This is a physical device, and the "ground truth" would relate to its physical and mechanical properties, not an assessment by human experts in the way an AI or diagnostic device would require.

4. Adjudication method for the test set

Not applicable/Not provided. See point 3.

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 surgical implant, not an AI or diagnostic device that involves human readers/interpreters.

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

Not applicable. This is a surgical implant, not an algorithm.

7. The type of ground truth used

For the physical performance tests (insertion strength, pull-out strength, bacterial endotoxin), the "ground truth" would be established by objective laboratory measurements following validated test methods.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

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