(70 days)
Rx Indication: Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and sebortheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.
This document describes a 510(k) premarket notification for the Alevicyn SG Antipruritic Gel. The device is a topical gel indicated for managing and relieving various dermatoses symptoms and pain from burns. The approval is based on substantial equivalence to predicate devices, and the provided text does not include a study demonstrating how the device meets specific acceptance criteria for performance metrics via a clinical trial measuring efficacy outcomes.
Instead, the provided information focuses on biocompatibility testing and bench testing to support the substantial equivalence claim. Since no clinical study on performance outcomes (e.g., reduction in itching, pain, erythema) is presented, I cannot provide details on acceptance criteria and a study that proves the device meets them in the way typically associated with human-in-the-loop or standalone AI performance studies.
Here's an assessment based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in itching or pain). The acceptance criteria mentioned are related to manufacturing specifications and safety/biocompatibility.
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with FDA Blue Book Memorandum #G95-1 ("Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995") and ISO 10993-1 ("Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"). | The biocompatibility evaluation for the Alevicyn SG Gel was conducted in accordance with these standards. The solution is considered a breached/compromised surface device with limited contact, and thus implied to meet the standards for its intended use category. (Specific results like "no cytotoxicity observed" are not detailed, but compliance is stated). |
| Bench Testing | Meets specifications and performance characteristics. | The following tests were reviewed: package integrity, visual inspection, pH, and Free Available Chlorine (FAC). The Alevicyn SG Gel meets specification and performance characteristics. (Specific numerical ranges or results for each test are not provided, only the statement of compliance). |
| Substantial Equivalence | Demonstrated equivalence to predicate devices in intended use, technological characteristics, safety, and effectiveness. | Alevicyn SG Gel is determined to be substantially equivalent to Alevicyn SG Gel (K143590), TL Triseb Cream (K121134), Dermiseb Cream (K123724), and Loutrex Topical Cream (K120730). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Biocompatibility Testing" and "Bench Testing" but does not specify the sample sizes (e.g., number of test subjects or samples of the gel) or the provenance of any data used for these tests. There is no mention of a human clinical test set for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The ground truth for biocompatibility and bench testing would be established by laboratory standards and measurements, not by expert consensus in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies where subjective assessments might be made (e.g., by multiple readers). The tests described (biocompatibility, bench testing) are objective laboratory tests.
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
This information is not applicable/provided. This device is a topical gel, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a topical gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For Biocompatibility Testing, the "ground truth" is defined by the International Standard ISO 10993-1 and FDA Blue Book Memorandum #G95-1. These are standardized methodologies and criteria for evaluating biological responses to medical devices.
For Bench Testing (package integrity, visual inspection, pH, Free Available Chlorine), the "ground truth" is established by predefined product specifications and validated analytical methods in a laboratory setting.
8. The sample size for the training set
This information is not applicable/provided. The device is a gel, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no training set for this type of device.
N/A