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The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Coalescent Surgical U-CLIP™ and Accessories:

Acceptance Criteria and Device Performance

Study Details

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed scientific study publication. As such, specific methodological details often found in a peer-reviewed research paper are condensed or omitted.

1. Sample Size used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in the provided summary. The text mentions "in vitro and in vivo data," implying animal or human testing, but no specific numbers for the test subjects or samples are given.
   • Data Provenance: Not explicitly stated. The nature of in vitro and in vivo studies suggests laboratory and potentially animal testing, but the country of origin or whether it was retrospective/prospective is not specified.

2. Number of Experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not mentioned. The "ground truth" here is less about expert consensus on interpretations (as in imaging studies) and more about objective functional performance measurements against established specifications and predicate device performance. The testing would likely be performed by engineers and technicians according to documented protocols.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., images) requires consensus. Here, the "ground truth" is based on objective measurements and comparisons.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The U-CLIP is a surgical device, not an AI interpretation tool.

5. Standalone (Algorithm Only) Performance:

   • No, a standalone algorithm-only performance study was not done. The U-CLIP is a physical medical device, not an algorithm. The assessment is of its physical and functional properties.

6. Type of Ground Truth Used:

   • The ground truth for the performance claims appears to be:
     • Objective Functional Measurements: Data derived from in vitro (laboratory) and in vivo (live organism) testing.
     • Comparison to Predicate Device Performance: The functional characteristics and safety profile of the U-CLIP were compared against already legally marketed predicate devices (other U-CLIP models and Ethicon sutures).
     • Compliance with Standards: Adherence to internal specifications, external standards (not explicitly named but implied by "external standard requirements"), and USP suture testing requirements.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. The U-CLIP is a manufactured device; there isn't a "training set" in the machine learning sense. Its design involved engineering, material science, and prior iterations (as indicated by the predicate devices).

8. How the Ground Truth for the Training Set was Established:

   • Not applicable/Not mentioned. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for its development would be based on design specifications, material properties, biomechanical principles, and the performance characteristics of its predecessors.

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