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The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.

The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.

This 510(k) Premarket Notification for the Vascular Stitcher does not contain the information you requested regarding acceptance criteria and a study to prove the device meets those criteria, as it is related to AI/ML software.

The document describes a medical device, the Vascular Stitcher, which is a physical surgical instrument (a needle holder/driver). The submission focuses on demonstrating substantial equivalence to predicate physical devices already on the market, rather than performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics for a software device. It states the Vascular Stitcher is a "stainless steel surgical product."
2. Sample size used for the test set and the data provenance: Not applicable to a physical surgical instrument submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) for the Vascular Stitcher primarily relies on demonstrating:

• Intended Use Equivalence: "The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures," which is equivalent to predicate devices.
• Technological Characteristics Equivalence: Stating it has "similar functions and is composed of similar materials as the predicate devices."
• Product Description: A stainless steel surgical product for use with compatible needles and sutures in a semi-automatic or manually operated mode.

The FDA's letter (K963965) confirms "substantial equivalence" to devices marketed prior to May 28, 1976, or reclassified devices. This is the primary method of approval for such a device, rather than a performance study against AI/ML-specific acceptance criteria.

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