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

MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone.

The provided text is a 510(k) summary for a medical device (MONOCRYL suture, undyed) seeking substantial equivalence to a predicate device (MONOCRYL suture, dyed). This submission type focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way one might for a novel AI device.

Therefore, the requested information elements related to AI device performance studies (sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. The document describes a comparison between two physical medical devices where the key metric is breaking strength retention.

Here's the breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria: The "acceptance criterion" here is implicitly that the BSR profile of the undyed suture must be the same as the predicate dyed suture, as this is how substantial equivalence is being claimed for this aspect.

2. Sample size used for the test set and the data provenance: Not applicable. This was non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical material properties is established through standardized laboratory testing, not expert consensus in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Laboratory measurement of "Breaking Strength Retention profile after implantation."

8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study was a nonclinical laboratory testing to compare the "breaking strength retention (BSR) profile after implantation" of the modified MONOCRYL suture, undyed, with its predicate device, MONOCRYL suture, dyed. The finding was that the BSR profile for both devices was identical. This equivalence in a key performance characteristic was a basis for concluding that the new device is substantially equivalent to the predicate device.

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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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