(83 days)
ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing.
The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP OTC™ Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a popopen screw cap on the other end).
The provided document is a 510(k) summary for a medical device called ASAP OTC™ Wound Dressing Gel. It details the device's characteristics, its intended use, and how it compares to a predicate device to establish substantial equivalence. However, it does not describe a study involving acceptance criteria and a detailed statistical analysis of device performance in the context of typical AI/ML device evaluations.
Instead, this document focuses on biocompatibility testing and antimicrobial effectiveness testing to establish the safety and basic functionality of the wound dressing gel. The "acceptance criteria" here are implied by meeting the standards of ISO 10993 for biocompatibility and USP for antimicrobial effectiveness.
Therefore, many of the requested specific points regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are common for AI/ML device evaluations, are not applicable to this type of device submission.
Here's an analysis based on the information provided, highlighting the differences in evaluation methodology:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets as one might see in an AI/ML clinical study. Instead, performance is demonstrated by conformance to recognized standards and by comparison to a predicate device.
| Acceptance Criteria (Implied by Standards/Demonstration) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993 | Found to be acceptable |
| Antimicrobial Effectiveness: Conformance to USP | Inhibited growth of: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, MRSA, VRE, Candida albicans, Aspergillus niger |
| Physical/Chemical Specifications (Comparative): | |
| - Appearance | Clear to golden yellow translucent gel (matches predicate) |
| - Odor | Odorless (matches predicate) |
| - Specific Gravity | 1.01 (predicate: 1.02) |
| - Flowability | At 45° & 90° - more than 5 min. to travel 1 inch from origin (matches predicate) |
| - Feel/Tackiness | 1 - smooth (matches predicate) |
| - Viscosity RT 30° | 25,000 - 60,000 (matches predicate) |
| - pH | 6.5 to 8.0 (matches predicate) |
| - Light Exposure | No further discoloration (matches predicate) |
| - Compatibility | No discoloration of product / reaction with containers (matches predicate) |
| - Moisture Donation | Greater than 5% (matches predicate) |
| - Moisture Uptake | Greater than 5% (matches predicate) |
Study Information (Based on available document):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for AI/ML. For biocompatibility and antimicrobial testing, the sample sizes would be determined by the respective standards (ISO 10993 and USP ). These are laboratory-based tests, not human subject studies.
- Data Provenance: The studies are laboratory-based (biocompatibility and antimicrobial effectiveness). This is not retrospective or prospective human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this type of device evaluation. Ground truth for biocompatibility and antimicrobial effectiveness is established by the methods and criteria defined in the specific standards (ISO 10993, USP ).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human expert adjudication of clinical findings.
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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 device is a wound dressing gel, not an AI/ML diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. The "performance" is the inherent physical, chemical, and biological properties of the gel.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the "ground truth" is adherence to established biological safety criteria as defined by ISO 10993, assessed through various biological reactivity tests (e.g., cytotoxicity, sensitization, irritation).
- For antimicrobial effectiveness, the "ground truth" is defined by the inhibition of specified microbial growth according to the quantitative criteria of USP . This is a direct microbiologic assessment.
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The sample size for the training set:
- Not applicable. This device does not use an AI/ML algorithm that requires training data. Device formulation and manufacturing processes are developed through R&D, not a "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the AI/ML context.
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