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The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.

The BioKnotless RC anchor is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone without the need for knot tying. The suture assembly is made up of a non-absorbable Ethibond or Panacryl anchor loop and a utility loop constructed of non-absorbable Ethibond Excel suture (green, #2/0). The Ethibond and Panacryl sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.

This document is a 510(k) Premarket Notification for a medical device called the BioKnotless RC Anchor. It is a submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a new premarket approval application (PMA).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific performance metrics in a structured table. Instead, it makes a general claim:

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

The document does not detail specific study methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective or prospective) for any performance testing beyond the general mention of "biocompatibility studies." This type of information is typically found in detailed study reports, which are not included in this summary. The 510(k) summary focuses on demonstrating equivalence rather than presenting comprehensive clinical study results.

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

This information is not applicable and not provided in the document. The context is a 510(k) submission for a medical device (surgical anchor) and not a diagnostic or AI-driven device that would require expert-established ground truth for its performance evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. As explained above, this is not a study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics or AI-assisted diagnostic tools, which is not the case for this surgical anchor. There is no mention of human readers, AI assistance, or an effect size.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone study (in the context of an algorithm's performance) was not done. The device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used:

The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to diagnostic or prognostic performance is not directly relevant here. For this device, "ground truth" would be related to its physical and biological properties. The "biocompatibility studies" assessed:

• Toxicity: Whether the material is harmful to living cells/tissue.
• Irritation: Whether it causes an inflammatory response.
• Cytotoxicity: Whether it causes cell death.

The "ground truth" for these assessments would be established through laboratory tests (e.g., in vitro assays, in vivo animal models) following established biocompatibility standards.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here. This is a medical device (surgical anchor), not an AI algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI algorithm.

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