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Rx Indication: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial 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, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.

The Alevicyn SG Antimicrobial Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer. Ingredients: Water, sodium lithium magnesium fluorosilicate, dimethicone, sodium phosphate, sodium bicarbonate, sodium chloride, sodium sulfate, with hypochlorous acid and sodium hypochlorite as gel preservatives.

The document provided describes a 510(k) Premarket Notification for the Alevicyn SG Antimicrobial Gel. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on showing equivalence through comparison and specific performance data, rather than detailing a direct study to "prove acceptance criteria" in the way one might for a novel device.

However, I can extract the acceptance criteria (specifications) and reported performance data based on the provided "Performance Data" section.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any of the biocompatibility or bench tests. It also does not specify the country of origin or whether the data was retrospective or prospective. The nature of these tests (e.g., in-vitro toxicology, chemical property testing) typically involves lab-based experiments rather than human clinical trials with "test sets" in the traditional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. For device submissions based on predicate equivalence and bench/biocompatibility testing, the "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1, USP ) and internal specifications for chemical and physical properties. There are no "experts" establishing ground truth in the context of clinical interpretation, as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or assessments, particularly for AI image interpretation. The studies described here are laboratory-based performance and safety evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI vs. Without AI Assistance

This information is not applicable and not provided. MRMC studies are relevant for evaluating diagnostic imaging systems (often AI-powered) where human readers interpret cases. The Alevicyn SG Antimicrobial Gel is a topical medical device, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, again typically for AI-driven diagnostic tools. This device is not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by:

• Adherence to recognized international standards like ISO 10993-1 ("Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process").
• FDA biocompatibility guidance (issued June 16, 2016).

For bench testing, the ground truth is established by:

• Internal specifications defined for pH, viscosity, FAC.
• Adherence to recognized pharmacopeial standards like **USP ** for antimicrobial preservative effectiveness.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical product (gel) and does not involve AI or machine learning models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, for the same reason as above (no AI/ML training set).

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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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