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OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, and minor burns.

Professional Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management.

Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

The provided text is a 510(k) Substantial Equivalence Determination letter from the FDA for a wound gel called Prontosan Wound Gel. This document states that the device is "substantially equivalent" to a legally marketed predicate device (Prontosan Wound Gel, K101882) and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The 510(k) process for this device, in particular, focuses on the manufacturer's claim that no changes have been made to the device design, packaging, manufacturing process, indications for use or the intended use. The submission is purely for labeling content changes.

Therefore, I cannot provide the requested information from this document. The document explicitly states:

• No new studies were conducted or required to demonstrate performance. The substantial equivalence is based on the device being identical to a previously cleared predicate device.
• No acceptance criteria are mentioned because the device's performance is assumed to be equivalent to the predicate, which would have already met its own performance criteria when it was initially cleared.

In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

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Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.

Atteris™ Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is dispersed in a unique non-cytotoxic, non-stinging solution via a standard 28 mL pump spray bottle. The product is biocompatible, non-stinging, fast drying, and has low friction. Antimicrobial Barrier Film Dressing protects minor wounds and damaged skin by providing a secure, breathable, waterproof barrier to external contaminates. The film dressing is colorless, transparent, and possesses good oxygen and moisture vapor permeability. The antimicrobial PHMB at a concentration of 0.001% w/w is added to the product as a preservative to inhibit the growth of microorganisms within the product.

The provided document is a 510(k) premarket notification for the "Atteris Antimicrobial Barrier Film Dressing" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria in the context of AI/machine learning performance.

Therefore, most of the requested information regarding AI/ML study design (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Performance Testing" section.

Acceptance Criteria and Reported Device Performance

Answers to other questions based on the provided document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes in-vitro lab testing, not a clinical study with a "test set" of patients/data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference standards for the performance tests were established using recognized international standards and methods, specifically:
   • USP 51 for antimicrobial effectiveness.
   • ISO 10993 parts 1, 5, and 10 for biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a medical device (a film dressing) and its performance is evaluated through standard laboratory and biocompatibility testing, not through AI/ML performance studies.

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