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Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

The proposed Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. The intended use of this device is achieved by physical action. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by the reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7 .0, the subject device achieves its primary mode of action through serving as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. There is no chemical action or metabolic effect associated with the mechanism of action of this device.

Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a small tube.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silatrix Oral Gel, structured to answer your specific questions.

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of your questions related to AI-specific elements (like AI-assisted MRMC studies, training set details, ground truth for AI, etc.) are not applicable to this type of submission. This summary primarily details non-clinical performance and comparisons to existing devices.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical device (oral gel) and not a software/AI device, the "acceptance criteria" are viewed through the lens of demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria would be that the device has the same intended use, similar technological characteristics, and similar principles of operation, and that any differences do not raise new questions of safety or effectiveness.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This document describes non-clinical performance data (biocompatibility, shelf-life, and chemical verification of sucralfate). It does not rely on a clinical "test set" of patient data in the way an AI/software device would.
   • The "study" here is primarily a comparison against a predicate device and laboratory testing. Specific sample sizes for biocompatibility or shelf-life testing are not provided in this summary. Data provenance (country, retrospective/prospective) is not detailed for these non-clinical tests.

2. 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):

   • Not applicable. There is no clinical "test set" or ground truth requiring expert consensus for a diagnostic or AI algorithm in this submission. The determination is based on non-clinical data and comparison to a predicate device.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as there is no clinical "test set" or ground truth requiring adjudication.

4. 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:

   • Not applicable. This is not an AI/software device. There were no human readers or AI assistance involved in the evaluation presented here.

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

   • Not applicable. This is not an AI/software device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical data:
     • Biocompatibility: In-vitro and in-vivo testing (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The "ground truth" is the established safety standard for these tests.
     • Component Verification: USP national standards (chemical analysis, e.g., spectroscopy, chromatography) to verify the presence and properties of sucralfate. The "ground truth" is adherence to these established chemical standards.
     • Equivalence: The established safety and effectiveness profile of the predicate device (ProThelial & Orafate Sucralfate Paste), which serves as a benchmark and "ground truth" for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/software device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for an AI algorithm.

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