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Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.

Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.

The provided FDA 510(k) summary for Synvaza and Synvaza II describes non-clinical and clinical performance testing but does not explicitly state formal acceptance criteria or directly report device performance against such criteria in a table format as requested. Therefore, the information has been extracted and presented as closely as possible to the request based on the available text.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As formal acceptance criteria are not explicitly defined in the document, I will infer what the acceptance criteria were based on the reported "Results" of the non-clinical tests. For the clinical study, the acceptance criteria are not quantifiable in the provided text.

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

• Non-clinical Testing: The sample sizes for the biocompatibility and preservation tests are not specified in the document.
• Clinical Performance Testing: The sample size is described as "preselected study subjects," but the exact number is not provided. The document does not specify the country of origin of the data, but the context of an FDA submission suggests it would be relevant to U.S. regulatory standards. The study was "open label, single arm," and involved using the device for 72 hours, which indicates it was a prospective study.

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

This information is not provided in the document. The clinical study describes self-reported pain relief by subjects, not a judgment by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the clinical study did not involve multiple readers or experts evaluating outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not mentioned or discussed in the provided document. The clinical study was a single-arm study evaluating the device's performance, not a comparison to human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The device is a physical wound rinse, not an algorithm or AI.

7. Type of Ground Truth Used

• Non-clinical Testing: The ground truth for biocompatibility and preservation tests would have been established through standard laboratory assays and compliance with specified standards (e.g., USP ).
• Clinical Performance Testing: The ground truth for pain relief was based on subjective self-reported experience of pain relief by the study participants.

8. Sample Size for the Training Set

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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