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The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded on an inserter with a polyester and PANACRYL, Poly (L-Lactide/Glycolide) synthetic absorbable] suture.

The provided text describes a 510(k) submission for the "Mitek Rotator Cuff QuickAnchor® Plus," which is a sterile, disposable bone anchor. The submission focuses on the substantial equivalence of modifications to an existing device, not a new AI/software-driven medical device. Therefore, many of the requested categories related to acceptance criteria for AI performance, clinical study design for AI, and ground truth establishment are not applicable.

Here's an attempt to extract the relevant information based on the provided text, and note where information is not available due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that "Performance testing: Arc span test, Insertion force, PullOut force, and Suture/Suture Hole interface" data was provided to support substantial equivalence. It does not disclose the specific quantitative acceptance criteria or the numerical results of these tests.

Information not available or not applicable based on the provided text:

Due to the nature of this 510(k) submission being for a mechanical medical device (bone anchor) and not an AI/software-driven diagnostic or prognostic tool, the following aspects are not detailed in the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device. Performance testing would typically involve laboratory bench testing, not clinical data sets in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI models is not relevant here.
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, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to the physical properties measured in performance tests, not clinical labels.
8. The sample size for the training set: Not applicable, as there is no "training set" for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

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