FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

AI/ML Overview

The GRINDCARE MEASURE device underwent performance testing to ensure it met design specifications and complied with relevant standards. The provided document does not contain details about specific acceptance criteria related to clinical performance (e.g., sensitivity, specificity for bruxism detection) or a clinical study that proves the device meets such criteria. Instead, it references compliance with general electrical safety and electromagnetic compatibility standards, and that its performance was previously tested for the predicate device (K092675).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Electrical Safety	IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety	Meets requirements
EM Compatibility	IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests	Meets requirements
Electromyographs Safety	IEC 60601-2-40: Medical Electrical Equipment Part 2-40: Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment	Meets requirements
RF Functionality	FCC CFR 47 Part 15, Subpart C	Meets requirements
Bouxism Detection	Not specified directly in terms of performance metrics like sensitivity/specificity for bruxism events.	"records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching)." "uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events."

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document refers to "device testing" and meeting "design specifications" and existing standards, but does not detail a clinical test set or its size for bruxism detection performance.
Data Provenance: Not specified. Based on the manufacturer's location (Denmark) and the referenced standards, it's likely testing was conducted to international standards. Whether a dedicated clinical study with human subjects for the GRINDCARE MEASURE was performed, and its nature (retrospective/prospective, country of origin), is not detailed.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

This information is not provided. The document focuses on technical and electrical safety standards rather than clinical performance validation against expert-established ground truth for bruxism diagnosis.

4. Adjudication Method for Test Set:

This information is not provided. As there's no detailed clinical study described, there's no mention of an adjudication method for a test set.

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

No, a MRMC comparative effectiveness study is not mentioned. The document does not describe any human-in-the-loop performance evaluation or comparison of human readers with and without AI assistance for the GRINDCARE MEASURE. The device is a diagnostic tool for measuring EMG activity, not an assistive AI for human interpretation.

6. Standalone (Algorithm Only) Performance Study:

Yes, in spirit, the device's ability to detect bruxing events represents a standalone performance. The document states: "It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder." This implies the device's internal processing (algorithm) identifies these events independently. However, specific standalone performance metrics (e.g., accuracy, sensitivity, specificity) against a clinical ground truth for bruxing events are not provided. The "performance data" section primarily lists compliance with technical standards.

7. Type of Ground Truth Used:

For the technical and safety standards, the ground truth would be the parameters defined by the respective IEC and FCC standards. For the detection of "bruxing events," the document implies that the EMG signals indicating muscle contraction serve as the basis for detection. However, it does not specify how the accuracy of this detection itself was validated against a gold standard for bruxism (e.g., polysomnography with video, expert observation, or clinical diagnosis).

8. Sample Size for Training Set:

This information is not provided. The document does not describe the development of an AI algorithm based on a training set for bruxism detection. The device "processes the signal to detect" events, but details on how this processing was developed or "trained" are absent.

9. How Ground Truth for Training Set Was Established:

This information is not provided as there is no mention of a training set for an AI algorithm in the provided text.

Summary

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).