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The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is a titanium suture anchor implant pre-threaded with three (3) distinct non-absorbable #2 ultra high molecular weight polyethylene sutures (white, blue and white striped, black and white striped). The design requires no pre-drilling and can be inserted by hand into the bone with the accompanying disposable driver. The device is substantially equivalent in design, performance specifications, function and intended use to the Super Revo Hi-Fi Suture Anchor. The design of the implant has not been modified.

The only difference between the ThRevo Anchor, Disposable Driver, Hi-Fi Sutures and the Super Revo with Hi-Fi is the addition of the third Hi-Fi suture. This modification introduces the use of black nylon 6.6 as a marker for the black cobraid, similar to the blue polypropylene for the blue cobraided suture.

The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. It is supplied sterile and single use.

Here's a breakdown of the acceptance criteria and study information 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 provided document does not specify a sample size for any test set or the data provenance (country of origin, retrospective/prospective). The document states "Testing conducted prior to product release," but details about this testing are omitted.

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

The provided document does not mention the use of experts to establish ground truth for a test set or their qualifications.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method.

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

The provided document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

6. Standalone Performance Study

The provided document does not detail a standalone (algorithm only without human-in-the-loop performance) study. The regulatory submission focuses on the device's substantial equivalence to a predicate device, rather than a novel algorithm's performance.

7. Type of Ground Truth Used

The provided document does not explicitly state the type of ground truth used. Given the context of a 510(k) submission for a physical medical device (suture anchor), it's highly likely that ground truth would be established through in-vitro biomechanical testing or in-vivo animal studies demonstrating properties like pull-out strength, loop security, or tissue integration, compared to the predicate device. However, these specific details are not present in the summary.

8. Sample Size for the Training Set

The provided document does not mention a training set or its sample size. This type of submission (for a physical device claiming substantial equivalence) generally doesn't involve machine learning or AI algorithms with distinct training and test sets in the way software devices would.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), the document does not describe how ground truth for a training set was established.

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