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Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.

The provided text describes the INTEGUSEAL Microbial Sealant, a device intended to reduce the risk of skin flora contamination during surgical procedures. The submission details a summary of the device, its intended use, and substantial equivalence to a predicate device, as well as the testing conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state numerical or specific performance acceptance criteria in a table format. However, it indicates the device was tested to demonstrate "substantial equivalence" to the predicate device, ACTI-Gard Antimicrobial Film, based on its ability to reduce the risk of skin flora contamination.

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

The document mentions "in vivo surgical incision microbial contamination testing" as part of the substantial equivalence testing. However, it does not specify the sample size used for this test set nor the country of origin or whether the data was retrospective or 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)

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily laboratory-based (in vitro) and clinical performance-based (in vivo microbial contamination) rather than subjective expert assessment.

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

The document does not specify any adjudication method. It describes testing and comparison to a predicate device, not a process involving multiple human evaluators making judgments that would require adjudication.

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

The device is a "Microbial Sealant," a physical product, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance would not be applicable and was not performed.

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

The device is a physical product, not an algorithm. Therefore, a standalone (algorithm only) performance study would not be applicable and was not performed.

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

The ground truth for the "in vivo surgical incision microbial contamination testing" would likely involve microbiological culture results quantifying the presence and levels of skin flora contamination, possibly compared to a control or the predicate device. This is a direct measurement of the biological outcome the device is designed to affect.

8. The sample size for the training set

The device is a physical product and does not involve machine learning or AI. Therefore, there is no training set in the context of AI/ML models.

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

As there is no training set for this device, this question is not applicable.

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