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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.

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.

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Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process.

OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.

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) screwtop closure and a finger pump sprayer.

The provided 510(k) summary for the Alevicyn SG Antipruritic Gel primarily focuses on establishing substantial equivalence to a predicate device (Epicyn Hydrogel) rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Alevicyn SG. The performance data section describes Biocompatibility Testing and Bench Testing performed.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific pain reduction percentages, itching reduction scores) in the way one might expect for a clinical trial. Instead, it relies on demonstrating that the device meets manufacturing specifications and biological safety standards, and that its characteristics are "substantially equivalent" to the predicate.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for specific efficacy studies. The biocompatibility and bench testing would have their own sample sizes based on the respective test protocols.
• Data Provenance: Not specified in terms of country of origin. The studies appear to be laboratory-based (biocompatibility, bench testing) and likely conducted by or for Oculus Innovative Sciences. The nature of these tests suggests they are prospective for the Alevicyn SG device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described (biocompatibility, bench testing) rely on standardized laboratory protocols rather than expert consensus on clinical outcomes.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing described does not involve expert adjudication of clinical outcomes.

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

No, a multi-reader multi-case comparative effectiveness study was not performed. This device is a topical gel, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a medical gel, not an algorithm or AI system.

7. The type of ground truth used

For biocompatibility and bench testing, the "ground truth" would be established by the compliance with defined industry standards (ISO 10993) and internal product specifications. For the claim of substantial equivalence, the "ground truth" is based on the characteristics and performance of the legally marketed predicate device (Epicyn Hydrogel K102945) as evaluated by the FDA.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to the type of device and testing described.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as in point 8.

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