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The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.

The proposed Arthrex Self Punching SwiveLock® Suture Anchors are fully threaded suture anchors comprised of a PEEK eyelet and a hollow anchor body preassembled on a disposable inserter. The anchor body is manufactured from either PLLA/βTCP or PEEK. The Arthrex Self Punching SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to the bone in the shoulder.

The document describes the Arthrex Self Punching SwiveLock® Suture Anchors and its substantial equivalence to a predicate device. It briefly mentions performance data but lacks the detailed information requested for acceptance criteria and a comprehensive study description.

Here's a breakdown of the available information and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria for "pull-out and insertion testing" and the actual numerical results of the device performance are not provided.

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

• Sample size for the test set: Not specified. The document only states "all samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• This information is not applicable as the study described is a performance/mechanical test, not one involving expert review of data for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable for a mechanical performance test.

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

• No, a MRMC comparative effectiveness study was not done. The study described is a mechanical performance test.

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

• Not applicable. This device is a physical medical device (suture anchor), not an algorithm or AI system.

7. Type of Ground Truth Used

• For the mechanical performance study, the "ground truth" would be the physical measurements obtained from pull-out and insertion testing, compared against pre-defined engineering or performance specifications. The document indicates these were met.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (See point 8).

Summary of the Study:

The provided text indicates that Arthrex Inc. performed "Pull-out and insertion testing" on the proposed Arthrex Self Punching SwiveLock® Suture Anchors and a predicate device (K191226: Arthrex SwiveLock Suture Anchor). The purpose of this testing was to demonstrate substantial equivalence to the predicate device. The results reported state that "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." This suggests that the mechanical performance of the new device in terms of its ability to be inserted and its pull-out strength was comparable and within acceptable limits when compared to the established predicate device. However, the specific details of these acceptance criteria and the quantitative performance data are not included in this document.

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