(162 days)
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the
The provided text describes a 510(k) summary for a medical device called Microcyn® Scar Management HydroGel. This is a Class I device and the submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device would.
Therefore, many of the requested categories (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this device.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria or performance metrics in terms of sensitivity, specificity, F1-score, etc., as would be common for AI/ML devices. Instead, the "acceptance criteria" for this submission are fundamentally about demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Meets specification and performance characteristics | "The Microcyn® Scar Management HydroGel meets specifications and performance characteristics" |
| Biocompatible according to ISO-10993 | "Biocompatibility Testing... confirmed that the device meets the applicable requirements... and is biocompatible." |
| Well-tolerated in study population | "The Microcyn® Scar Management HydroGel was well tolerated in the study population" |
| Efficacy indicates substantial equivalence to predicate device | "efficacy results indicate substantial equivalence to the predicate device, Kelo-cote® Scar Gel." |
| Does not raise new safety and efficacy concerns | "The Microcyn® Scar Management HydroGel does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed." |
| Substantially equivalent in intended use, technological characteristics, safety, and effectiveness to predicates (Kelo-Cote Topical™ Gel and Beau Rx Scar Care Gel) | "The Microcyn® Scar Management HydroGel is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Kelo-Cote Topical™ Gel and Beau Rx Scar Care Gel." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any "test set" in the context of an AI/ML device evaluation. The document mentions a "study population" for clinical testing, but the specific number of participants is not provided.
- Data Provenance: Not specified. It's a clinical study, likely prospective, but no details on country of origin are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This type of submission does not involve "ground truth" derived by experts for diagnostic or AI/ML performance evaluation. The clinical study would have assessed outcomes based on standard clinical evaluations.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. There's no "test set" or adjudication process described for establishing ground truth as understood in AI/ML validation studies.
5. 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 topical hydrogel, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of AI/ML validation. For the clinical study, efficacy would likely be based on clinical assessments of scar appearance, symptoms, and physician/patient satisfaction, typically compared to the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.