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The GrindCare System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep.

The GrindCare System is a portable electromyographic (EMG), electrical stimulation, and biofeedback device. It consists of a Sensor that is adhered to the skin over the temporalis muscle by means of an adhesive, disposable, single-use GelPad. The System also includes a Docking Station, USB Cable, and Power Adaptor. The Sensor and Docking Station record and store EMG activity data, which is transferred from the Docking Station to the GrindCare Mobile App, which allows the user to review grinding and stimulation data and enter diary notes. The Sensor uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event.

The provided document describes the GrindCare System, a biofeedback device intended to aid in the evaluation and management of sleep bruxism by reducing temporalis muscle EMG activity during sleep. The substantial equivalence determination is based on a comparison to a predicate device (GrindCare, K092675), which is a previous version of the same system.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the typical sense with pass/fail thresholds. Instead, it describes various performance tests and compares the subject device's functionality to that of the predicate device. The underlying acceptance criterion for each aspect is essentially that the subject device's performance is equivalent to or better than the predicate device, or that it meets relevant safety and performance standards.

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

• Test Set Sample Size: The document states that the clinical data demonstrated a statistically significant reduction in EMG events per hour "on a representative patient population." However, the specific sample size for this clinical study (test set) is not provided in the document.
• Data Provenance: The document does not specify the country of origin of the data or whether the clinical study was retrospective or prospective. It is implied to be a conducted study for the purpose of this submission ("The clinical study demonstrated...").

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 provided in the document. The device automates the detection of EMG activity and applies stimulation. The "ground truth" for the clinical study appears to be the measured EMG activity itself, which the device processes. There is no mention of human experts interpreting raw EMG data or establishing a "ground truth" for bruxing events in the test set, beyond the device's own detection.

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

This information is not applicable as the document does not describe a scenario involving multiple human readers or interpretations needing adjudication for the test set. The clinical study seems to be based on the device's ability to measure and respond to EMG activity.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or referenced. The study described focuses on the device's direct effect on EMG activity reduction, not on how human readers (e.g., clinicians) perform better with or without AI assistance from this specific device. The device is a biofeedback system that directly interacts with the patient, not an AI diagnostic aid for human readers.
• Effect Size of Human Reader Improvement: This is not applicable as an MRMC study was not described. The provided effect size of 32.45% reduction is in EMG events due to the device's intervention, not an improvement in human reader performance.

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

Yes, in essence, the "clinical study" section (p. 8), which demonstrated the 32.45% reduction in EMG events, represents the standalone performance of the algorithm (as implemented in the device) in reducing temporalis muscle EMG activity. The device is designed to automatically detect and respond to bruxing events without continuous human intervention during the night.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the clinical study described appears to be the measured temporalis muscle EMG activity itself. The device's performance is measured by its ability to reduce this objectively measurable physiological activity. The "grind threshold" is automatically calculated based on background noise (p. 7), suggesting an automated, objective measure rather than subjective expert consensus or pathology results.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given the device is an evolution of a predicate with a "modified detection algorithm," it's possible such data was used, but it is not mentioned in this summary.

9. How the ground truth for the training set was established

This information is not provided in the document.

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