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Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.

Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.

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I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The provided text consists of premarket notifications (510(k)) for several Gengigel® products (Prof Gel, Prof Fluid, Junior, Spray, Gel, and Mouthrinse).

These documents primarily focus on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through clinical studies. The FDA's 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device, meaning they have the same intended use and the same technological characteristics, or have different technological characteristics but do not raise different questions of safety and effectiveness.

The provided text does not contain information related to specific acceptance criteria (e.g., target true positive rate, false positive rate, or other metrics), the methodologies of a specific study to meet those criteria, or the detailed results of such a study.

Therefore, I cannot provide information on the following points:

• A table of acceptance criteria and the reported device performance: No such criteria or performance data are detailed.
• Sample size used for the test set and the data provenance: No test set or data provenance from a specific study is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment for a test set are described.
• Adjudication method: No adjudication method for a test set is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study or effect size related to human readers improving with AI is mentioned, as these are medical devices, not AI algorithms in the context of interpretation.
• Standalone (i.e., algorithm only without human-in-the-loop performance): Not applicable as these are topical gels/mouthrinses, not algorithms.
• Type of ground truth used: No ground truth for a performance study is described.
• Sample size for the training set: No training set or machine learning aspects are mentioned.
• How the ground truth for the training set was established: Not applicable.

The existing documents confirm that the Gengigel® products were deemed "substantially equivalent" to their respective predicate devices (Gelclair® Oral Gel and Aloclair™ Oral Gel/Spray/Rinse). This determination allows them to be marketed, subject to general controls. The basis for this substantial equivalence is the intended use as dressings for wound and burn (hydrogel with drug and/or biologic) and similar indications for temporary pain relief and protection of oral mucosa. The FDA letter confirms the regulatory decision based on the 510(k) submission.

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