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K Number
K212554
Device Name
Bonvadis Topical Cream
Manufacturer
StemCyte Inc.
Date Cleared
2022-08-19

(371 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

N/A