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Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

Based on the provided text, the document is an FDA 510(k) clearance letter and summary for a medical device called Bonvadis®. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific, quantitative acceptance criteria through a comparative effectiveness study, especially not for AI/ML-enabled devices.

Therefore, most of the requested information regarding acceptance criteria, study design parameters (sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set details), and statistical proof of meeting those criteria is not applicable to this document. The provided text describes non-clinical testing to support the device's safety and effectiveness for a wound dressing, not a study involving AI/ML performance metrics.

However, I can extract the relevant information regarding the performance data and the conclusion drawn from it within the context of a 510(k) submission for this type of device.

Here's a breakdown based on the provided document, addressing the prompts where information is available or indicating its absence/non-applicability:

The provided document describes the 510(k) clearance for a wound dressing called Bonvadis®. This process primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria via a clinical comparative effectiveness study, especially not for an AI/ML device. The "performance data" mentioned refers to non-clinical tests.

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

The document does not present quantitative acceptance criteria in the typical sense of an AI/ML medical device performance study (e.g., sensitivity, specificity thresholds). Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness comparable to predicate devices. The "reported device performance" is that the device meets the criteria of these tests.

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

The document refers to "non-clinical tests" and does not specify sample sizes in the context of human data or AI/ML test sets. The tests are laboratory-based (e.g., chemical, physical, microbial, biocompatibility). Data provenance is not described in terms of country of origin or retrospective/prospective as it pertains to product testing, not clinical data.

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

Not applicable. The ground truth for chemical, physical, and microbial tests is established by laboratory standards (e.g., USP monographs, ISO standards), not by human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

Not applicable for non-clinical laboratory tests.

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 a wound dressing, not an AI-enabled diagnostic or treatment device.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by established laboratory testing methodologies and specifications, such as those outlined in United States Pharmacopeia (USP) standards (e.g., USP, USP, USP) and potentially ISO standards for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable.

In summary, the provided document is a 510(k) clearance for a conventional medical device (wound dressing) and therefore does not contain the information typically associated with the development and validation of an AI/ML-enabled medical device. The "performance data" refers to standard quality control and safety testing of the physical product, not the statistical performance of an algorithm.

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Bonvadis Topical Cream is indicated for the management of minor skin lacerations, cuts, and minor burns.

Not Found

This document is a 510(k) clearance letter from the FDA for a topical cream, Bonvadis Topical Cream, indicated for the management of minor skin lacerations, cuts, and minor burns.

This document DOES NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to an AI/ML powered device. The product is a topical cream, not an AI/ML powered medical device.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria for AI/ML Performance: The document is for a topical cream, not an AI/ML device. Thus, there are no acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
• No Study Data: The document is a regulatory clearance letter, not a clinical study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for a 510(k) clearance for this type of product. It does not provide detailed performance data from a clinical trial, especially not one that would involve AI/ML performance metrics.
• No AI/ML Specifics: All specific points requested in your prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training ground truth establishment) are relevant to the evaluation of AI/ML based medical devices. Since this is a topical cream, these concepts do not apply.

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