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The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.

The NobleStitch™ EL, MR. and TA versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.

This is a 510(k) premarket notification for the NobleStitch™ EL, MR, and TA vascular suturing devices. As such, the documentation provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics.

Here's an analysis of the provided text in relation to your questions:

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

The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance in the way you might expect for a typical study. This is common for predicate pathway 510(k) submissions, where the primary argument is that the new device is "substantially equivalent" to an already cleared device.

Instead of formal performance metrics against acceptance criteria, the submission makes the argument of equivalence based on:

• Intended Use/Indications for Use: Identical to the predicate device.
• Technological Characteristics: Essentially the same as the predicate, with minor modifications related to "different diameters or lengths with improved handle ergonomics."
• Principles of Operation: Identical to the predicate device.

The core assertion is that "The minor modifications to the NobleStitch™ do not raise any new questions of safety or effectiveness." This statement implies that the new device will perform equivalently to the predicate, and therefore, no new performance data or acceptance criteria are explicitly required beyond demonstrating that the modifications do not negatively impact safety or effectiveness.

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

The document does not describe any specific test set, sample size, or data provenance for a clinical study. The submission relies on the concept of substantial equivalence to a predicate device (SuperStitch® Vascular Suturing Device). This means that the safety and effectiveness are inferred from the predicate, and new clinical data typically isn't required unless the changes are significant enough to raise new questions of safety or effectiveness.

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 detailed in the provided document as there is no mention of a clinical study involving a test set that required expert ground truth establishment.

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

This information is not applicable or mentioned because no clinical test set requiring adjudication is described.

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 or mentioned. The device is a manual vascular suturing device, not an AI-assisted diagnostic tool.

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

This information is not applicable or mentioned. The device is a manually operated surgical instrument, not an algorithm.

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

This information is not detailed as no specific clinical study with ground truth data is described. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device.

8. The sample size for the training set

This information is not applicable or mentioned as the device is a manual surgical instrument and not an AI or algorithmic system that requires a training set.

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

This information is not applicable or mentioned for the same reason as point 8.

In summary:

This 510(k) submission is a "predicate pathway" submission, which means it seeks to demonstrate that the new device (NobleStitch™ EL, MR, and TA) is "substantially equivalent" to an already legally marketed device (SuperStitch® Vascular Suturing Device). For such submissions, the FDA typically does not require new comprehensive clinical studies with detailed acceptance criteria, sample sizes, and expert adjudications, unless the changes from the predicate raise new questions of safety or effectiveness. The core argument here is that minor ergonomic and diameter/length changes do not alter the fundamental safety or effectiveness demonstrated by the predicate device.

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