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The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.

The EpiGuard is a single use oral protective device manufactured from biocompatible silicone. It is provided clean (non-sterile). Besides providing a physical barrier to prevent tongue and cheek damage of the user, the device will maintain an open airway in the mouth cavity and allow the free flow of air and vomit. In addition, the device is griped under the palatals and teeth of the user while also being held in front by the interior surface of the lips. This allows the EpiGuard to be fixed to the necessary position to prevent it from being swallowed.

This document describes the acceptance criteria and the study that proves the device meets those criteria for the EpiGuard bite block.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 10 subjects.
   • Data Provenance: The study was an observational study conducted by the manufacturer, EpiSafe Medical Devices, Ltd., in Israel. The nature (retrospective/prospective) is not explicitly stated, but "observational study" typically implies prospective data collection for the specific evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The study involved subjects grading the device's performance, not experts establishing ground truth for a diagnostic output.

3. Adjudication method for the test set:

   • Not applicable. The study involved subject self-grading (scale of 1-5) on device performance, not expert adjudication of a classification.

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:

   • No MRMC comparative effectiveness study was done. This device is a physical bite block, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This device is a physical bite block, not an algorithm.

6. The type of ground truth used:

   • Subjective assessment of device performance by the users (subjects) themselves, graded on a scale of 1-5 for 13 specific aspects.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set in the conventional sense. The "dimensions were based upon the measurements from dental impressions of men and women above the age of 10," which might be considered analogous to "training data" for design, but it's not a computational training set.

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

   • Not applicable as it's not an AI/ML algorithm. The design of the device was based on "measurements from dental impressions of men and women above the age of 10." The "ground truth" for the design would be anatomical averages and variations within the target user population.

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