(183 days)
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.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.