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510(k) Data Aggregation
(422 days)
BITESTRIP
The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.
The BiteStrip is intended as an aid in the evaluation of excessive nocturnal jaw muscle activity The device is generally indicated for use by orofacial pain professionals or dentists, to evaluate nocturnal masticatory muscle activity level. which may be related to the patient's braxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.
The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours.
The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.
The provided text describes the BiteStrip device and its 510(k) summary, but it does not contain a detailed study report that proves the device meets specific acceptance criteria.
However, it does describe the device's intended use and mentions a correlation study without providing specific performance metrics or detailed methodology. I can extract the information that is present and note where information is missing.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of a table or specific measurable thresholds. It describes the device's output and how it correlates with bruxism severity.
| Acceptance Criteria (Not explicitly stated, but implied goal) | Reported Device Performance (from text) |
|---|---|
| Aid in evaluation of nocturnal masticatory muscle activity | The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Bscore). |
| The Bscore correlates with bruxism severity derived from formal sleep lab studies. | |
| "While both Bscore and traditional bruxism score are very similar, and have good correlation..." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "formal sleep lab studies" without further detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions "formal sleep lab studies" as the source of "traditional bruxism score" used for comparison.
4. Adjudication method for the test set
The document does not specify any adjudication method used for the test set.
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
The document does not describe an MRMC comparative effectiveness study directly involving human readers' improvement with or without AI assistance. The BiteStrip is presented as a diagnostic device that outputs a "Bscore," not as an AI-assistant for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the BiteStrip appears to be a standalone device that provides an automated output (the Bscore) based on EMG analysis. The description states: "The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3..." and "the Bscore is obtained by EMG analysis alone." This indicates standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for comparison is the "traditional bruxism score" derived from formal sleep lab studies using sleep lab EMG and additional physiological measures.
8. The sample size for the training set
The document does not specify the sample size for any training set.
9. How the ground truth for the training set was established
The document does not describe how the ground truth for a training set was established. It implies the device was developed to correlate with "traditional bruxism score" from formal sleep lab studies, which would serve as the reference.
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