(120 days)
Rx Indications for Use:
Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
OTC Indications for Use:
Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
The Microcyn Plus Skin and Wound Hydrogel is a clear gel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of 12,000-20,000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for most of the requested parameters. The document is a 510(k) summary for a medical device (Microcyn Plus Skin and Wound Hydrogel), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with acceptance criteria.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for clinical performance. Instead, it reports biocompatibility and bench testing results. The acceptance is implicitly that the device performs safely and effectively, and is substantially equivalent to predicates.
| Study Title | Reported Device Performance | Interpretation of "Acceptance" (Implicit) |
|---|---|---|
| Agar Diffusion Test - ISO | No biological reactivity (Grade 0) observed in the L929 cells at 48 hours post exposure. | No cytotoxicity observed, indicating biocompatibility. |
| Acute Dermal Toxicity - OECD | The test substance is considered non-toxic according to the study protocol criteria. | Non-toxic when applied dermally. |
| Primary Eye Irritation | Mildly irritating to the eye. No other signs of gross toxicity, adverse pharmacological effects, or abnormal behavior. | Tolerable eye irritation (though it's noteworthy that it is irritating) but no systemic toxicity. |
| Cumulative Skin Irritation Test - FHSA | Negligible irritant – no signs of erythema or edema were noted at any observation period. | Non-irritating to skin with repeated exposure. |
| Intracutaneous Injection | Irritant when injected under the skin. | Irritant when injected, indicating it's not suitable for subcutaneous injection (relevant for its intended topical use). |
| Kligman Maximization Test, Direct Contact - ISO | The test article elicited no reaction, a Grade I reaction as defined by the scoring system of Kligman, classified as having weak allergenic potential. | Low allergenic potential. |
| Bench Testing (overall) | The Microcyn Plus Hydrogel meets specification and performance characteristics (package integrity, visual inspection, viscosity, pH, Free Available Chlorine). | Device meets manufacturing and quality specifications for physical and chemical properties. |
Missing Information:
- 2. Sample sized used for the test set and the data provenance: Not mentioned. These are biocompatibility and bench tests, not clinical trials with human subjects as "test sets" in the typical sense for AI.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility and bench tests are laboratory-based, not expert-adjudicated clinical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hydrogel, not an AI diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For biocompatibility, the "ground truth" is defined by standardized test methods and their established biological endpoints (e.g., cell viability, toxicological response). For bench testing, it's defined by product specifications and analytical methods.
- 8. The sample size for the training set: Not applicable. The device is a wound hydrogel, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
This document describes a medical device seeking 510(k) clearance, which means it relies heavily on demonstrating substantial equivalence to legally marketed predicate devices, primarily through technological characteristics and non-clinical performance data (like biocompatibility and bench testing) rather than extensive new clinical studies. The questions you've asked are more typically relevant for AI/ML-enabled diagnostic devices or devices that require new clinical efficacy data for approval or clearance.
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