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Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).

This document describes the FDA's decision regarding the substantial equivalence of a medical device, specifically Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture, to a predicate device.

It is crucial to understand that this document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence. It is NOT a study report for an AI/ML medical device that would involve performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, are not applicable to this document. This submission relies on the device being identical to its predicate.

Here's the breakdown based on the provided document:

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

• Acceptance Criteria: Based on this 510(k) submission, the primary acceptance criterion for this device to achieve substantial equivalence is that its technological characteristics, intended use, and performance are identical to the legally marketed predicate device (K132580).
• Reported Device Performance:

  Criterion	Reported Performance
  Functionality	Identical to the predicate device.
  Technological Characteristics	Identical to the predicate device.
  Intended Use	Identical to the predicate device.
  Material	No material changes from the currently marketed devices.
  Device Construction	No device construction changes from the currently marketed devices.
  Performance Specification	No performance specification changes from the currently marketed devices.
  Packaging	No packaging changes from the currently marketed devices.
  Sterilization	No sterilization changes from the currently marketed devices.
  Manufacturing Process	No manufacturing process changes from the currently marketed devices.
  Safety and Effectiveness	The proposed device does not raise new questions of safety or effectiveness compared to the predicate device.

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

• Not Applicable. This document does not describe a performance study with a test set in the context of AI/ML validation involving patient data. The basis of equivalence is the device's technical and material identity to an already cleared predicate.

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

• Not Applicable. Ground truth establishment by experts is not described as part of this 510(k) submission, as it's not an AI/ML device requiring such performance validation.

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

• Not Applicable. No test set or adjudication method 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:

• Not Applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant to this type of device submission.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable. The concept of "ground truth" as applied to AI/ML performance validation is not relevant here. The "truth" of equivalence is based on industrial and chemical specifications and previous FDA clearances.

8. The sample size for the training set:

• Not Applicable. No training set is involved as this is not an AI/ML device.

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

• Not Applicable. No training set ground truth was established.

In summary, this document is a regulatory submission demonstrating the substantial equivalence of a surgical suture based on its identical nature to a previously cleared predicate device. It does not contain information related to the performance testing typically associated with AI/ML medical devices.

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