Search Results

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

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.

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:

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.

Ask a specific question about this device

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

GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode. 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 stimulator. 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. 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 EMG events are logged and stored on the device. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

The provided text refers to a 510(k) summary for the GRINDCARE device, a biofeedback device for nocturnal bruxism. However, the document provided does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance criteria beyond general conformity to standards.

Here's an analysis based on the information available:

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

The document does not provide a table of explicit, quantitative acceptance criteria for the device's performance in reducing temporalis muscle EMG activity, nor does it report specific performance metrics against such criteria.

The "Performance Data" section states:
"Device testing was performed and the device was shown to meet its design specifications."
"Device performance will also be in conformance to the following standards prior to marketing: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-40."
"RF function of the device meets requirements of FCC CFR 47 Part 15, Subpart C."

These statements indicate that the device met internal design specifications and general safety/EMC standards, but they do not provide specific clinical performance metrics (e.g., % reduction in EMG activity, sensitivity, specificity for bruxing events). The "clinical data are provided to demonstrate safety and effectiveness" but the details of this clinical data (acceptance criteria, results) are not present in this summary.

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

This information is not provided in the given 510(k) summary. The document mentions "Clinical data are provided to demonstrate safety and effectiveness," but it does not specify the sample size, type of study (prospective/retrospective), or data provenance for any clinical test set.

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 given 510(k) summary. Given the nature of the device (EMG for bruxism), ground truth for bruxism events would typically involve clinical assessment or expert interpretation of polysomnography/EMG recordings, but no details are given.

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

This information is not provided in the given 510(k) summary.

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

This type of study is not applicable to the GRINDCARE device as described. The GRINDCARE is an electromyographic and electrical stimulation device that directly senses and treats bruxism; it is not an AI-assisted diagnostic tool for human readers/clinicians to interpret. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

The device itself operates as a standalone system to detect EMG activity and deliver stimulation. The text states: "It 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..." This describes the device's standalone operation. However, no specific performance metrics for this standalone detection and stimulation (e.g., accuracy of bruxism detection, effectiveness of stimulation) are detailed in this summary.

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

The document does not explicitly state the type of ground truth used for any clinical data that was provided. For a bruxism device, ground truth often involves polysomnography with EMG recordings, expert clinical diagnosis, or patient-reported outcomes, but this is not specified here.

8. The sample size for the training set

This information is not provided in the given 510(k) summary. The device uses signal processing to detect events, which implies some form of training or calibration, but details are absent.

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

This information is not provided in the given 510(k) summary.

In summary, the provided 510(k) document is a high-level summary that indicates conformity to general safety and design standards and states that clinical data was provided to demonstrate safety and effectiveness for substantial equivalence. However, it explicitly lacks the detailed clinical study design, acceptance criteria, test set/training set sizes, ground truth establishment methods, and specific performance results that would answer most of your detailed questions. These details would typically be found in the full 510(k) submission, not in this brief summary.

Ask a specific question about this device