(155 days)
AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.
AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.
The provided text is a 510(k) summary for the AcryDerm Silver Antimicrobial OTC Wound Gel. It discusses the device's characteristics, intended use, and the basis for its substantial equivalence to predicate devices, primarily for a change from prescription to over-the-counter (OTC) status.
However, the document does not describe acceptance criteria or a study designed to prove the device meets specific performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating the device's antimicrobial properties and safety for OTC use based on existing data and standard tests.
Here's an analysis of the provided information in the requested format, with an emphasis on what is not present in the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Antimicrobial Barrier Activity: Demonstrated effectiveness against a broad spectrum of bacteria and fungi (e.g., Staphylococcus epidermitis, E. coli, Pseudomonas aeruginosa, MRSA, Candida albicans, etc.) | Established by Kirby-Bauer zone of inhibition test. Specific results (e.g., inhibition zone sizes) are not provided. Maintained barrier function for more than 3 days in in vitro serial transfer testing. |
| Preservative Efficacy: Conformity with USP Preservative Challenge Test. | Conforms with the USP Preservative Challenge Test against specified organisms. Specific pass/fail criteria or quantitative results are not provided. |
| Biocompatibility: Assessed according to ISO standard (Biological Evaluation of Medical Devices). | Assessed according to Part-1 of the ISO standard. Specific results or a summary of findings (e.g., non-cytotoxic, non-irritating) are not provided. |
| Safety and Performance for OTC Use: Demonstrated safety and performance based on prior clearance (K011994) and continuous distribution as a prescription product. | "The complaint history, biocompatibility, safety, and performance in a wound healing study show that it would be safe for wider and more direct access of this product by patients." Details of the wound healing study are not provided. |
Notes on Acceptance Criteria: The document states that the device conforms or was established by certain tests, implying these tests inherently define the "acceptance criteria" for that type of product (e.g., passing the USP Preservative Challenge Test is the criterion). However, explicit numerical or qualitative cut-offs for these criteria are not mentioned in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Kirby-Bauer and USP Preservative Challenge Tests: Not explicitly stated. These are in vitro tests typically performed with bacterial/fungal cultures.
- For the "wound healing study": The sample size is not provided.
- Data Provenance: Not explicitly stated, meaning country of origin is unknown. The Kirby-Bauer and USP tests are standard laboratory methods. The "wound healing study" is likely retrospective, as it refers to performance from a previously cleared product that has been "in continuous distribution since 2002."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable/not provided. The device is an antimicrobial wound gel, not a diagnostic device requiring expert interpretation of results for "ground truth" establishment in the context of image analysis or similar tasks. The "ground truth" for antimicrobial efficacy comes from laboratory assays (Kirby-Bauer, USP Challenge) and clinical observation of safety and performance (wound healing study).
4. Adjudication Method for the Test Set
- Not applicable/not provided. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not a diagnostic imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This product is a medical device (wound gel), not a software algorithm. Its performance is assessed through in vitro and in vivo (human use, though details are scant) studies, not algorithm performance.
7. The Type of Ground Truth Used
- Antimicrobial Efficacy: Laboratory results from standardized tests (Kirby-Bauer, USP Preservative Challenge Test) against known microorganisms.
- Biocompatibility: Results from tests conducted according to ISO standards.
- Safety and Performance in Wound Healing: Clinical outcomes observed during the use of the previously cleared prescription product. The specific nature of "outcomes data" (e.g., wound closure rates, infection rates) is not detailed.
8. The Sample Size for the Training Set
- Not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set." The product's performance is based on intrinsic material properties and biological interactions.
9. How the Ground Truth for the Training Set was Established
- Not applicable/not provided. See point 8.
N/A