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MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Ankle: Mid-foot reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested analysis. The document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus bone anchor) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices for regulatory approval.

Here's why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Device Performance Table: The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study that would demonstrate the device meets those criteria. The only safety information provided is a general statement about "Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." This is a qualitative statement, not a performance metric with acceptance criteria.
• No Description of a Study for Performance Evaluation: The text does not describe any specific study (clinical trial, bench test with performance endpoints, etc.) that was conducted to prove the device meets performance criteria. The mention of "biocompatibility studies" is the only hint of testing, but no details are given about their methodology, sample size, or results in relation to performance criteria.
• Missing Information for AI/Algorithm-Specific Questions:
  • The device described (bone anchor) is a physical medical device, not an AI or algorithm-driven product. Therefore, questions related to AI performance, sample sizes for test/training sets, ground truth establishment for algorithms, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and cannot be answered from this document.

In summary, the provided document is a regulatory submission for a physical medical device, not a performance study report for an AI/algorithmic medical device. Therefore, it lacks all the specific information you've requested regarding acceptance criteria, study details, and AI-related metrics.

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