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Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.

The provided document is a 510(k) summary for a medical device (Vesocclude™ Polymer Ligating Clip) and does not describe AI/ML device performance or a clinical study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as this information is not present in the provided text.

The document primarily states:

• The device is a non-absorbable, nonactive implantable clip for ligation of vessels and tissue structures.
• It is substantially equivalent to the Teleflex Medical Hem-o-lok® Ligating Clips.
• Performance testing (nonclinical) included dimensional analysis, clip applier compatibility, post aging performance, functional testing for resistance to leakage and migration, and biocompatibility testing. These tests were conducted to demonstrate equivalence to the predicate device, not necessarily to specific acceptance criteria for a novel AI/ML device.

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Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.

Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.

The provided text describes a 510(k) submission for the Vesocclude Ligating Clip, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone studies) is not present in the document.

Here's a breakdown of what can be extracted:

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

This information is not provided in the document. The submission focuses on substantial equivalence based on design, material, and metallurgical characteristics, rather than defined performance metrics with acceptance criteria.

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

This information is not provided. The submission does not describe a clinical performance study with a test set. The evaluation is based on non-clinical data, specifically metallurgical comparative analysis.

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)

This information is not provided. As there is no clinical performance study with a test set, there are no experts involved in establishing ground truth.

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

This information is not provided. As there is no clinical performance study with a test set, there is no adjudication method.

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

This information is not applicable/not provided. This device is a medical implant (ligating clip), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this submission.

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

This information is not applicable/not provided. This device is a medical implant, not an algorithm, so a standalone performance study in this context is not relevant.

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

This information is not provided. For this type of submission, the "ground truth" is typically established by physical and chemical properties and comparison to known predicate devices, rather than clinical outcomes or expert consensus. The "metallurgical comparative analysis" serves as the basis for comparison.

8. The sample size for the training set

This information is not applicable/not provided. The term "training set" is relevant for machine learning algorithms. This submission pertains to a physical medical device and does not involve a training set.

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

This information is not applicable/not provided. As there is no training set for a machine learning algorithm, there is no ground truth established in this context.

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