(296 days)
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
TMJ Relax™ is durable medical equipment in the form of a mouthguard that is fitted to the teeth that temporarily provides traction on the mandible such that it repositions the mandible to reduce muscle tension. The device is a removeable home use product that a consumer may wear up to 22 hours per day, in other words except when eating or during sports activities. The TMJ Relax™ system is a single or series of appliances prescribed for patients with a history of a diagnosis of temporomandibular joint disorder and/or migraines/tension headaches. The device is a one-part removeable oral appliance fitted on the mandibular or maxillary teeth that repositions the mandible while sleeping or during sedentary daytime use. The appliance is patient fitted by using a computer aided manufacturing protocol.
The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning the TMJ Relax device. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting the results of a standalone study with acceptance criteria and performance data in the format requested.
Therefore, this document does not contain the detailed information required to fully answer the request regarding acceptance criteria and a study proving the device meets them.
The document explicitly states:
- "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Page 8, Section 10. Clinical Performance Data)
- "The subject device is identical and/or substantially equivalent to the predicate devices, and introduces no new risks or concerns compared to the predicates." (Page 8, Section 10. Clinical Performance Data)
This means there wasn't a dedicated clinical study performed on the TMJ Relax device itself with defined acceptance criteria for its performance. Instead, the submission relies on the established safety and efficacy of the predicate devices.
However, I can extract information related to the device and its claimed equivalence:
Device Information:
- Device Name: TMJ Relax™
- Intended Use: Prophylactic treatment of medically diagnosed migraine pain and migraine-associated tension-type headaches, by reducing signs and symptoms through reduction of trigeminally innervated muscular activity; and for the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity.
- Mechanism of Action: Disocclusion and temporary repositioning of the mandible.
- Technology: Computer-aided design and manufacturing algorithm for custom fitting, 3D printed thermoplastic resin appliance.
Inferences based on the provided text (though not actual study data):
Since no specific study is described with acceptance criteria, the table below will reflect the claimed performance based on substantial equivalence to predicate devices rather than measured performance from a study of the TMJ Relax device itself.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric/Criterion (Implied via Predicate Equivalence) | Reported Device Performance (Implied via Predicate Equivalence) |
|---|---|---|
| Safety | Biocompatibility (ISO 10993-1 compliance) | Complies with ISO 10993-1 for surface contacting device with mucosal membrane for long-term use (>30 days). Uses biocompatible acrylic resin. |
| Absence of novel risks | Does not raise new questions of safety; at least as safe as predicate devices. | |
| Effectiveness | Prophylactic treatment of medically diagnosed migraine pain and migraine-associated tension-type headaches by reducing signs and symptoms (based on predicate) | Expected to reduce signs and symptoms for migraine pain and tension-type headaches, equivalent to predicate. |
| Prevention of bruxism (based on predicate) | Expected to prevent bruxism, equivalent to predicate. | |
| Prevention of TMJ syndrome (based on predicate) | Expected to prevent TMJ syndrome, equivalent to predicate. | |
| Reduction of trigeminally innervated muscular activity (based on predicate) | Expected to reduce trigeminally innervated muscular activity, equivalent to predicate. | |
| Usability/Usability | Ease of use by adult patients in a home setting | "Easy to use, reversible method." User manuals provided to healthcare providers and patients. |
| Method of disinfection | Disinfected with soap and water; air dry. |
Since no clinical study was performed for this 510(k) submission, the following sections cannot be populated with specific data for the TMJ Relax device. I will indicate this where appropriate.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no dedicated test set from a clinical study was reported for the TMJ Relax device.
- Data Provenance: Not applicable. The "performance" is based on the established history and data of predicate devices (NTI-TSS NTI Tension Suppression System K010876 and Luco Hybrid OSA Appliance K160477), which have been on the market for many years.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical study with a test set requiring ground truth establishment was conducted for this submission.
4. Adjudication method for the test set:
- Not applicable, as no clinical study with a test set was conducted for this submission.
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:
- Not applicable. This device is a physical mouthguard, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical mouthguard, not an algorithm, in the context of typical AI/software performance studies. The "proprietary computer aided design and manufacturing algorithm" is for fabrication, not for diagnostic or clinical performance assessment in the sense of a standalone algorithm study.
7. The type of ground truth used:
- Not applicable, as no direct clinical study with a ground truth was conducted for this submission. The "ground truth" for the substantial equivalence claim relies on the long-standing clinical experience and performance of the predicate devices for similar indications.
8. The sample size for the training set:
- Not applicable, as no machine learning model requiring a training set for clinical performance was described in the context of this submission's regulatory requirements. The mention of a "proprietary computer aided design and manufacturing algorithm" refers to device fabrication, not a clinical diagnostic algorithm.
9. How the ground truth for the training set was established:
- Not applicable, for the same reasons as in point 8.
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