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The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

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

The provided text describes a 510(k) summary for the Coalescent Surgical U-CLIP™ and accessories, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on demonstration of equivalence rather than extensive de novo clinical trials with predefined acceptance criteria and performance metrics in the way a novel AI algorithm would.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in the provided document, as it is not typically required for a 510(k) submission based on substantial equivalence to a predicate device.

However, I can interpret the available information to answer what data was presented and how the device met its 'acceptance criteria' in the context of a 510(k).

Here's how the information relates to your request:

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

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

• Sample size for test set: Not specified. The document only mentions "In vitro data" and "product technical information." Clinical data with specific sample sizes for a "test set" in the context of an AI device are not present.
• Data provenance: Not specified. The data is described as "In vitro data." No information about country of origin or whether it was retrospective/prospective is provided, as this is not relevant for an in-vitro performance test of a mechanical device.

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 specified. This information is relevant for AI algorithms relying on expert annotations for ground truth. This document pertains to a medical device (surgical clip), where "ground truth" would be established through engineering specifications, material testing, and performance against defined physical standards.

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

• Not applicable/Not specified. Adjudication methods are typically used when human experts review and categorize data, often in the context of AI model evaluation or clinical trials with subjective endpoints. This document focuses on a physical device.

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. An MRMC study is completely irrelevant for this type of medical device (surgical clip). MRMC studies are designed to evaluate the impact of medical imaging devices or AI aids on human reader performance, which isn't the function of the U-CLIP.

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

• Not applicable. The U-CLIP is a physical surgical device, not an algorithm. Therefore, "standalone algorithm performance" doesn't apply.

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

• The "ground truth" for this device would be based on engineering specifications, material properties, and performance benchmarks for mechanical strength, biocompatibility, and functional operation (e.g., clip closure force, material integrity under stress, sealing capability). The document states "internal specification requirements, as well as external standard requirements and device performance expectations." This implies that the device was tested against established physical and material standards.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. As above, there is no "training set" for this physical device.

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