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The U-CLIP™ Uni-Fire is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

The U-CLIP™ is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The Model M65 U-CLIP" Uni-Fire device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. The clip is released from a slot in the side of the hypotube. After release, the arms of the clip attempt to regain their preferred, closed configuration, thereby holding the tissue layers together. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured with a standard implantable grade of Nitinol.

The provided text describes a 510(k) premarket notification for the U-CLIP™ Uni-Fire, Model M65, not a study involving AI or complex performance metrics. The information is solely about demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and general function. Therefore, most of the requested fields are not applicable or cannot be extracted from this document, as they pertain to clinical studies, AI performance, and expert evaluations.

Here's an attempt to answer the questions based only on the provided text, explicitly stating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment. All test data obtained satisfied the documented product and performance specifications."
However, specific quantitative acceptance criteria or reported performance values (e.g., exact clip strength in Newtons, deployment success rate) are not provided in this summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," but no details for this submission's testing.

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

Not applicable. This is a medical device submission, not an AI or diagnostic tool study requiring expert-established ground truth. The "ground truth" for the device's function would be its physical performance against engineering specifications.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based diagnostic studies. For this device, performance is likely assessed against engineering specifications.

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

No, an MRMC study was not done. This device is an implantable clip, not a diagnostic or AI-assisted tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the device's functional characteristics (clip strength, deployment), which were tested.

7. The Type of Ground Truth Used:

For a medical device like the U-CLIP, the "ground truth" refers to its compliance with fundamental engineering and design specifications (e.g., material properties, dimensions, mechanical strength, deployment mechanism). The text implies its performance was verified against "documented product and performance specifications," which serve as the ground truth for its functional characteristics. No pathology, outcomes data, or expert consensus as a ground truth for performance is mentioned for this particular submission.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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