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The Anson Refix tissue and vascular clip is intended:

• To assist in the creation of anastomoses in blood vessels, grafts, and, .
• For the surgical approximation of tissue to tissue, or tissue to woven graft . material for general and vascular surgery.

The Refix tissue and vascular clip consists of an implantable clip and a delivery system. The Anson Refix Clip is comprised of a single monofilament, Nitinol wire, which is sharpened at both ends. The arms of the device are curved as in a bow and are separated via a loop of wire in the center.

The provided text is a 510(k) summary for the Anson Refix Clip, a medical device. It describes the device's intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics and study methodologies (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The document states: "Appropriate product testing was conducted to evaluate conformance to riproprise specification and substantial equivalence to predicate devices." This is a general statement and does not provide the detailed information requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.

Here's a breakdown of why the information is missing and what can be inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document generally mentions "Appropriate product testing," but no specifics on sample sizes, test set composition, or data provenance.

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 / Not provided. This device is a surgical clip, not a diagnostic imaging AI. "Ground truth" in the context of diagnostic AI refers to adjudicated diagnoses or pathology results. For a physical device like this, testing would involve engineering, material, and biocompatibility assessments, not "ground truth" established by experts in a diagnostic sense. Details about any clinical experts involved in performance testing are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. See explanation for #3.

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

• No. This is a physical surgical clip, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant or applicable to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical surgical clip, not an algorithm. Standalone performance as defined for AI (algorithm only) is not relevant. The device itself is "standalone" in the sense that it performs its intended function (clipping) without inherent "human-in-the-loop" AI decision-making.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable / Not provided in detail. For a medical device like this, "ground truth" would relate to objective measurements of physical properties (e.g., tensile strength, corrosion resistance, biocompatibility standards, securement force), and potentially in vivo or ex vivo surgical outcomes in animal or cadaver models, or clinical observations for predicate device equivalence. The document only states "conformance to appropriate specification and substantial equivalence to predicate devices."

8. The sample size for the training set

• Not applicable. This is a physical 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 explanation for #8.

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