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MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.
MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL suture, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.

This document describes a medical device submission (K960653) for a MONOCRYL (poliglecaprone 25) suture, dyed. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.

It's important to note that this submission is for a surgical suture, not an AI/ML powered device. Therefore, the questions regarding AI/ML-specific criteria (such as AI assistance, training/test sets, ground truth establishment, expert qualifications, etc.) are not applicable to this document. The "device" in this context refers to the physical surgical suture.

Here's the information as it applies to the provided text:

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

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

• Not Applicable. This is a physical suture, and the "test set" for performance evaluation would refer to the materials and conditions used for testing the suture's physical properties. The document states "Nonclinical laboratory testing was performed to determine breaking strength retention." It does not specify sample size, country of origin, or whether it was retrospective/prospective.

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)

• Not Applicable. As this is not an AI/ML device, the concept of "experts to establish ground truth" (as it relates to image interpretation or diagnosis) is not relevant. The performance (breaking strength retention) is determined through laboratory measurements.

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

• Not Applicable. Adjudication methods are typically used to resolve discrepancies among human readers or expert opinions in diagnostic tasks, which is not relevant here.

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-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• Mechanical/Physical Measurement Data: The ground truth for the performance claim (breaking strength retention) is derived from nonclinical laboratory testing that measures the physical properties of the suture.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML device, this question is not relevant.

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