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The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.

The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided text is a 510(k) summary for the Coalescent Surgical Sutured-Clip, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or extensive study data as one might find for a novel device undergoing clinical trials to prove efficacy.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance for AI devices is not explicitly available within the provided K994160 document.

However, based on the text, I can infer and extract some relevant information as best as possible within the limitations of the provided document.

Acceptance Criteria and Reported Device Performance

The document states:
"All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."
"Design analysis, in vitro, in situ and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."

Given this, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate devices and meeting "internal specification requirements" and "external standard requirements." The reported device performance is that it met these unstated criteria.

Study Details (Based on available information)

2. Sample sizes used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "in vitro, in situ and chronic in vivo studies" but does not quantify the number of tests or subjects.
• Data Provenance: Not specified, but generally, pre-market studies for medical devices like this would be conducted by the manufacturer, likely in a controlled laboratory setting or animal models for in vivo studies. No country of origin for data is stated, nor is it explicitly retrospective or prospective, though in vivo studies would typically be prospective for testing a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/not specified. The document describes engineering and biological performance testing, not diagnostic performance where expert ground truth would be established.

4. Adjudication method for the test set:

• Not applicable/not specified.

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:

• Not applicable. This is not an AI-powered diagnostic device, but a physical surgical implant.

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

• Not applicable.

7. The type of ground truth used:

• For the in vitro and in situ testing, ground truth would likely be based on established engineering principles, physical measurements (e.g., tensile strength, leak resistance, securement force), and comparison to the performance of predicate devices.
• For the in vivo studies, ground truth would be biological outcomes (e.g., successful anastomosis, tissue integration, absence of adverse reactions, long-term patency of vessels) assessed against expected physiological norms and predicate device performance.

8. The sample size for the training set:

• Not applicable/not specified. This is a physical device, not an AI model requiring a "training set."

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

• Not applicable.

Conclusion from the K994160 Summary

The K994160 summary focuses on demonstrating "substantial equivalence" of the Coalescent Surgical Sutured-Clip to existing predicate devices based on design analysis, in vitro, in situ, and in vivo testing. The document highlights that the device met internal specifications and external standards, confirming its basic functional characteristics are on par with marketed devices. It does not provide the detailed statistical analysis or reader study information typically associated with AI/diagnostic device approvals, as it is a different class of medical product.

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