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MONOCRYL™ Plus Antibacterial Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.

MONOCRYL™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2

MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m.

This document is a 510(k) premarket notification for a medical device called MONOCRYL™ Plus Antibacterial Suture. It seeks to demonstrate substantial equivalence to a previously cleared device. Therefore, the information provided focuses on the equivalence of the modified device to its predicate, rather than detailing a de novo study to establish acceptance criteria and prove performance against them as would be typical for a novel device or AI/software.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific 510(k) submission:

Understanding the Context:

This submission (K201996) is for a modified device (MONOCRYL™ Plus Antibacterial Suture) that is largely identical to a predicate device (MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 with 510(k) number K050845). The only reported changes are to the labeling, specifically updating in vitro effectiveness against an additional microorganism and including new descriptors/icons.

For a 510(k) involving minor changes, the "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as the predicate, or that the changes do not raise new questions of safety or effectiveness. The "study" in this context refers to the data presented to support this claim, rather than a clinical trial for a new product.

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

Since this is a submission for a modified device essentially claiming no change in technological characteristics, the "acceptance criteria" are implicitly that the modified device retains the performance attributes of the predicate. The "reported device performance" is essentially a reaffirmation of the predicate's performance, along with specific in vitro data for the antibacterial claims.

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

The document mentions "in vitro efficacy studies" for the antibacterial claims. Details on the specific sample sizes (e.g., number of suture samples, number of bacterial cultures) are not provided in this summary. The data provenance is described as "in vitro," implying laboratory studies, rather than patient data. No information on country of origin or retrospective/prospective nature is given, as it's not a clinical study.

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

This type of information is generally relevant for AI/radiology devices where expert consensus is used to label images. For a physical medical device like a suture, "ground truth" for material properties and antibacterial efficacy is established through standardized laboratory testing and validated analytical methods (e.g., chemical analysis, microbiology assays). The document does not specify the number or qualifications of experts involved in running these in vitro tests, as this is typically handled by qualified laboratory personnel following established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This document describes laboratory in vitro studies for which such an adjudication method is not relevant.

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 device is a physical surgical suture, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

Not applicable. This document is about a physical medical device, not an algorithm or AI.

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

For the antibacterial claims, the "ground truth" would be established by the results of the microbiological in vitro assays which directly measure the inhibition of bacterial colonization on the suture material. For the material properties, the "ground truth" is established by chemical and physical testing against established standards (e.g., USP monographs). This is empirical data from laboratory studies, not consensus of human experts on subjective interpretations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires training data.

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

Not applicable, as explained in point 8.

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MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.

The provided text describes a 510(k) premarket notification for a medical device, MONOCRYL* Plus Antibacterial Suture. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as might be described in a PMA (Premarket Approval) application.

Therefore, many of the requested details, such as specific acceptance criteria for numerical performance metrics, sample sizes for test sets to establish ground truth, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly provided in this type of submission document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices. This means the new device must be as safe and effective as a legally marketed device and share similar technological characteristics and indications for use.
  • Specifically, for performance, the device had to conform to the USP Monograph for absorbable surgical sutures (except for diameter) and perform as intended and claimed in in-vivo/in-vitro testing.
• Reported Device Performance:
  • "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures."
  • "Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed."

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

• Not explicitly stated. The document mentions "non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not provide specific sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or included in a 510(k) summary.

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

• Not applicable. This submission doesn't involve subjective interpretations or diagnoses that would require expert-established ground truth in the way clinical diagnostic devices do. The testing described (USP monograph compliance, in-vivo/in-vitro performance) relies on objective measurement standards.

4. Adjudication method for the test set

• Not applicable. As there's no expert-established ground truth in this context, no adjudication method would be used.

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 device is a surgical suture, not a diagnostic imaging device or an AI-powered system that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This is a physical medical device (suture) and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective, standardized measurements against the USP Monograph for absorbable surgical sutures and general biological/mechanical performance evaluations (in-vivo/in-vitro testing) to ensure it performs as intended and claimed. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner of diagnostic devices.

8. The sample size for the training set

• Not applicable. The device is a physical suture, not a software algorithm requiring a training set.

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

• Not applicable. (See point 8).

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