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The AUTO SUTURE* Modified VCS* Clip ** Applier is available in multiple sizes and has application in the closure of arteriotomies and venotomies and sizes and bas application in cacular prosthesis, the creation of everting the actacument of Syleacer values provential tubular structures, and for the approximation of prosthetic grafts and dural tissue.

The AUTO SUTURE* Modified VCS* Clip** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Vascular Anastomosis Clip** applier - 510(k) #K933887. Both the subject and predicate devices are designed to apply a single titanium clip to soft tissues. Both the subject devices and other currently marketed United States Surgical Corporation devices are manufactured in the same facilities, using similar processes . and controls. Both the subject devices and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls. Both the subject and predicate devices perform the exact same function in the same way. Both the subject and predicate devices are manufactured from the exact same bioapproved materials.

This is a 510(k) premarket notification for a medical device (AUTO SUTURE* Modified VCS* Clip** Applier), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data. Therefore, many of the requested sections (2-9) are not applicable or cannot be extracted from the provided text.

Here's an analysis based on the provided documents:

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

The provided text does not define specific quantitative "acceptance criteria" in the way one would see for a new, novel device's performance evaluation. Instead, the core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device.

The "reported device performance" is essentially the claim of identical safety and effectiveness, and functional equivalence to the predicate device.

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

The document mentions "performance evaluation by USSC's PreQuality Assurance Laboratory and an independently contracted research laboratory." However, it does not specify sample sizes, country of origin, or whether the data was retrospective or prospective. Given the nature of a 510(k) for substantial equivalence, experimental data is typically not as extensive as for a PMA (Premarket Approval). The focus is on demonstrating similar characteristics to a legally marketed 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)

This information is not provided in the document. The "performance evaluation" likely referred to internal engineering and possibly preclinical testing, not typically involving "experts" in the context of clinical ground truth establishment for a diagnostic device.

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

This information is not provided.

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 is not applicable. The device is a surgical clip applier, not a diagnostic or AI-assisted device that would involve human readers or MRMC studies for interpretive tasks.

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

This is not applicable. The device is a mechanical surgical instrument.

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

The document does not detail the type of "ground truth" used for its performance evaluation. For a surgical device, this would likely involve mechanical testing, in vitro or ex vivo testing on tissue models, and potentially animal studies to assess clip deployment, security, tissue approximation, and biocompatibility, but the specific methodologies are not outlined here.

8. The sample size for the training set

This is not applicable. The device is a mechanical surgical instrument and does not involve AI or machine learning that would require a "training set."

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

This is not applicable. The device is a mechanical surgical instrument and does not involve AI or machine learning that would require a "training set."

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