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PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDS™ Plus Antibacterial Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)n.

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

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

This document is a 510(k) premarket notification for a medical device called PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture. The document focuses on establishing substantial equivalence to a predicate device (K061037) rather than presenting a performance study with detailed acceptance criteria for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, study details, and AI/CAD specific metrics cannot be found or inferred from the provided text.

The document states: "The subject device is identical to the predicate device in terms of material, construction, specification, manufacturing, and sterilization process." and "There are no physical or technological characteristic changes to the currently marketed predicate device." The primary change described is a revision to the Indications for Use, removing ophthalmic surgery and adding in-vitro effectiveness against Enterobacter cloacae.

To address the prompt, I can only provide the information that is present in the document.

Based on the provided text, the following information is not available:

• A table of acceptance criteria and reported device performance (as would be typical for a new performance claim or an AI/CAD device).
• Sample size used for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth for a test set.
• Qualifications of experts.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

However, the document does mention an in-vitro study related to antibacterial efficacy. Here's what can be extracted about that:

1. Acceptance Criteria and Reported Device Performance (Related to antibacterial efficacy for the new claim):

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

• The document refers to "in-vitro studies" but does not specify sample sizes for these studies or data provenance beyond being "in-vitro."

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/Not mentioned. The efficacy claim is for an antibacterial agent, likely assessed through microbiological methods, not human expert interpretation of images or other clinical data.

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

• Not applicable/Not mentioned.

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/CAD or diagnostic imaging device.

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

• Not applicable. This is not an AI/CAD or diagnostic imaging device.

7. The type of ground truth used:

• For the antibacterial claim, the ground truth is established through quantitative in-vitro attachment assays measuring bacterial colonization. This is primarily a laboratory measurement rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable/Not mentioned. This is not a machine learning or AI device that would typically have a "training set."

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

• Not applicable/Not mentioned.

In summary, the provided document is a 510(k) for a surgical suture and does not contain the detailed performance study information typically requested for an AI/CAD device. The "study" mentioned is an in-vitro assay for antibacterial efficacy, and even for that, specific sample sizes and detailed methodology are not provided in this regulatory summary.

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