(168 days)
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.
| Test Type | Acceptance Criteria (Implicit from context) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Complies with ISO 10993 standards for breached/compromised surface devices with limited contact. | All tests completed (Cytotoxicity, Systemic Injection, Primary Ocular Irritation, Direct Contact Cumulative Skin Irritation, Buehler Sensitization) met ISO standards. |
| Bench Testing | Meets specifications for package integrity, visual inspection, pH (5.5-7.0), Free Available Chlorine (140-150 ppm), and antimicrobial preservative effectiveness. | The Alevicyn SG Gel meets specification and performance characteristics. |
| Substantial Equivalence | Intended use, technological characteristics, safety, and effectiveness are comparable to the predicate device (Epicyn Hydrogel K102945). | The Alevicyn SG Gel is substantially equivalent to the predicate device. |
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.
N/A