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The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.

The Arrow Non-Absorbable Silk Suture has the following characteristics: Black, braided silk suture thread of '000' (Metric 2) diameter, 30" (75 cm) suture thread length, Pre-attached, straight, stainless steel needle, 2-3/8" (60 mm) needle length

The provided document is a 510(k) summary for a Non-Absorbable Silk Suture. This type of device approval primarily relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for a novel AI or diagnostic device. As such, many of the requested categories are not applicable or cannot be extracted from this specific document.

Here's an attempt to address the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, "performance tests" were conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device's performance is comparable to or "favorable" compared to the predicate devices in these tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the tensile strength, needle attachment, suture diameter, or biocompatibility tests. It also does not mention what would typically be considered "test sets" in the context of AI or diagnostic device studies, nor does it refer to "data provenance" (country of origin, retrospective/prospective data). These are bench tests performed on the physical device.

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

This information is not applicable to a submission for a physical medical device like a suture, which relies on standardized bench testing and biocompatibility assessments, not expert-derived ground truth.

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

Not applicable. Bench tests do not involve expert adjudication in the same way as clinical or AI performance studies.

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 a physical medical device, not an AI or diagnostic tool designed to assist human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the performance tests, the "ground truth" is defined by the standards themselves (e.g., USP 29 and ISO 10993-1). The device's characteristics are measured against the specifications outlined in these standards and against the performance of predicate devices. For biocompatibility, it's about whether the material elicits an adverse biological response according to the ISO standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; there is no "training set."

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

Not applicable. There is no training set for this device.

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