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The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older.

The DentiTrac(t) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(t) System.

Airway Management, Inc. has a family of intra-oral appliances known and referred to as the Thornton Appliance Positioner ("TAP®") family.

There have been a number of 510(k) clearances and the TAP® versions are all fundamentally the same. They are:

• Separate upper and lower trays
• Contain trays custom fitted to each patient
• Have a coupling mechanism (single point midline) that allows adjustment by way of incremental advancement of the mandible
• Allows the sleep specialists to titrate the advancement for optimum treatment effect
• Both Customized trays and Standard sized trays
• Mandibular advancement acts to increase the patient's pharyngeal space during sleep.

This submission is to offer the option of an embedded micro-recorder, DentiTrac® which will record and track a patient's compliance to the prescribed oral appliance therapy.

The DentiTrac® can be incorporated into any of the TAP® family of intraoral appliances.

The DentiTrac® micro-recorder monitors the wear time through oral temperature, tracks movements, and head position. The DentiTrac® provided information when used with the DentiTrac® System. During scheduled visits, the DentiTrac® data can be transferred to a cloudbased web application for reporting and tracking.

The addition of the DentiTrac® does not alter the principle of operation, technological characteristics, or safety of the TAP® family of intraoral appliances, which are the reference devices.

The provided text is a 510(k) summary for the TAP® 1 and TAP® 3 intra-oral appliances with an embedded DentiTrac® micro-recorder. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria for device performance.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request.

Instead, it relies on demonstrating that the modified device (TAP® with DentiTrac®) is substantially equivalent to a predicate device (SomnoMed SomnoDent® with micro-recorder) and reference devices (TAP® 1 and TAP® 3 without the micro-recorder). The rationale is that the DentiTrac® micro-recorder has already been cleared under K150369, and its embedding does not alter the performance of the TAP® device as an intra-oral appliance, thus requiring no additional performance testing.

Here's a breakdown of what is and isn't present in the document based on your request:

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

   • Not present. The document focuses on comparing the proposed device's characteristics (indications for use, technology, materials, environment of use, patient population) with predicate and reference devices, not on quantifiable performance metrics against specific acceptance criteria.

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

   • Not present. No new performance study or test set is described for the combined device. The reliance is on existing clearances for the components.

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):

   • Not present. No new study requiring expert ground truth establishment is detailed.

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

   • Not present. No new study requiring adjudication is detailed.

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 present. This device is an intra-oral appliance with a compliance micro-recorder, not an AI-assisted diagnostic tool for human readers.

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

   • Not present. While the DentiTrac® micro-recorder likely has internal algorithmic functions for data collection (temperature, movement, head position), the document doesn't detail its standalone performance or validation studies. It states that "data is available under MAF2557" for the DentiTrac® micro-recorder, implying its individual performance was assessed previously.

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

   • Not present for the combined device. For the original clearance of the DentiTrac® micro-recorder (K150369), there would have been ground truth for its compliance measurement function (e.g., actual wear time compared to recorded wear time), but this is not discussed here.

8. The sample size for the training set:

   • Not present. This is not a machine learning or AI device that typically involves a training set in the conventional sense.

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

   • Not present. Follows from point 8.

In summary, the document serves as a regulatory submission demonstrating substantial equivalence based on the concept that embedding an already cleared component (DentiTrac® micro-recorder) into an already cleared device (TAP® intra-oral appliance) does not introduce new safety or effectiveness concerns, and therefore, no new performance data or acceptance criteria for the combined device are required to be presented in this 510(k) summary.

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