(60 days)
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
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.
The provided FDA 510(k) clearance letter and summary for Bonvadis® do not contain any information regarding clinical performance studies, such as those involving human readers or expert panels, nor do they specify acceptance criteria for such studies.
The acceptance criteria mentioned in the document are primarily related to non-clinical performance tests proving the device's physical properties, safety, and functionality.
Here's the information that can be extracted or deduced from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical performance acceptance criteria or corresponding results are provided in the document, the table below focuses on the non-clinical tests mentioned. The document states that the results "meet the criteria" or "demonstrated that the device is as safe, effective, and performs as well as the predicate devices," implying successful completion of these tests against internal or regulatory standards, though specific numerical criteria are not detailed.
| Acceptance Criterion (Test Type) | Reported Device Performance |
|---|---|
| Shelf-life stability | Results meet criteria (implied successful stability over shelf-life) |
| In-use stability | Results meet criteria (implied successful stability during use) |
| Transepidermal Water Loss (TEWL) | Performed to support safety and effectiveness (implied successful performance to maintain moist wound environment) |
| Water retention capacity | Performed to support safety and effectiveness (implied successful performance to maintain moist wound environment) |
| Biocompatibility tests | Met (implied non-toxic and compatible with human tissue) |
| Toxicological risk assessment | Met (implied no unacceptable toxicological risks) |
| Usability | Performed to support safety and effectiveness (implied successful usability) |
| Transportation tests | Performed to support safety and effectiveness (implied successful withstand of transport conditions) |
| pH value | Results meet criteria (implied neutral pH) |
| Microbial Limit (USP, ) | Results meet criteria (implied acceptable microbial count) |
| Weight | Results meet criteria (implied consistent product weight) |
| Viscosity | Results meet criteria (implied consistent product viscosity) |
| Water loss rate | Results meet criteria (implied acceptable water loss rate for product integrity) |
| Endotoxin testing | Results meet criteria (implied acceptable endotoxin levels) |
| Preservative Efficacy (USP) | Results meet criteria (implied effective preservation against microbial growth) |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for clinical performance. The document exclusively refers to non-clinical tests on the device itself (e.g., stability, physical properties, biocompatibility). There is no mention of a "test set" of patient data or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As there are no clinical performance studies or test sets involving patient data, no experts were used to establish ground truth for such a purpose.
4. Adjudication method for the test set
Not applicable/Not provided. No adjudication method is mentioned as there were no clinical performance studies requiring expert review of data.
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/Not provided. This device is a topical wound dressing, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a physical product (wound dressing), not a software algorithm.
7. The type of ground truth used
Not applicable/Not provided for clinical performance. For the non-clinical tests, the "ground truth" refers to established scientific and regulatory standards (e.g., USP monographs for microbial limits, pH, preservative efficacy) against which the device's physical and chemical properties were measured.
8. The sample size for the training set
Not applicable/Not provided. This refers to clinical or AI model training data, neither of which are mentioned or relevant to the non-clinical tests described for this wound dressing.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no mention of a training set for an AI model or clinical study, this information is not available.
N/A