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510(k) Data Aggregation
(60 days)
Bonvadis**®**
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.
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(265 days)
Bonvadis**®**
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.
| Feature/Test | Acceptance Criteria (Implied: Comparable to Predicate/Standard) | Reported Device Performance |
|---|---|---|
| Shelf-life stability | Maintain properties over time within specifications. | Performed; results meet criteria as per USP. |
| In-use stability | Maintain properties during and after typical use by consumer. | Performed; results meet criteria as per USP. |
| Transepidermal water loss (TEWL) | Likely demonstrates ability to maintain skin barrier / moist wound environment similar to predicate devices. | Performed. |
| Water retention capacity | Demonstrates ability to maintain a moist wound environment. | Performed. |
| Biocompatibility tests | Meets ISO 10993 standards for biological safety (e.g., cytotoxicity, sensitization, irritation). | Performed; "Biocompatibility evaluation" was done. |
| Toxicological risk assessment | Absence of unacceptable toxicological risk. | Performed. |
| Usability | Clear instructions, ease of application/use for the intended user (healthcare professional). | Performed. |
| Transportation tests | Withstands transportation conditions without degradation or damage. | Performed. |
| pH value | Within an acceptable range, likely neutral, similar to predicates. | Conducted; "results meet the criteria as per USP." (Note: USP is for preservative efficacy, not pH directly, but pH is often a factor) |
| Microbial limit (per USP and USP) | Below specified microbial contamination levels. | Conducted; "results meet the criteria as per USP." (Again, USP is for preservative efficacy, implying effective preservation against microbial growth). |
| Weight | Consistent product weight. | Conducted. |
| Viscosity | Consistent semi-viscous formulation. | Conducted. |
| Water loss rate | Consistent with maintaining a moist wound environment. | Conducted. |
| Endotoxin testing | Below specified endotoxin limits (important for topical products that may be applied to compromised skin). | Conducted. |
| Preservative efficacy (as per USP) | Preservatives effectively inhibit microbial growth within the product. | Conducted; "results meet the criteria as per USP." |
| Overall Safety and Effectiveness (Conclusion) | The device is as safe, effective, and performs as well as the predicate devices. | "Bonvadis has demonstrated that the device is as safe, effective, and performs as well as the predicate devices." |
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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