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The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm.

The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments.

There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right.

Variants / Configurations

There are two variants of the device.

The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms.

The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.

AI/ML Overview

The provided document is a 510(k) summary for the RADx Intraoral Appliance for Snoring & Sleep Apnea. It describes the device and its compliance with regulatory standards, focusing on biocompatibility. However, it explicitly states that "Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the subject device." Instead, the substantial equivalence to predicate devices and material biocompatibility testing are the bases for its clearance.

Therefore, many of the requested items related to clinical study performance and ground truth cannot be answered from this document.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since no clinical performance study was conducted for this device, a direct comparison of acceptance criteria to reported device performance metrics like sensitivity, specificity, accuracy, etc., is not available in the document. The performance testing focused on biocompatibility.

Acceptance Criteria (from predicate/standards)	Reported Device Performance (RADx Intraoral Appliance)
Biocompatibility:
Non-Cytotoxic	Non-Cytotoxic (for BioMed Clear and dental LT Clear V2 Resins)
No cytotoxic potential	No cytotoxic potential (for BioMed Clear and dental LT Clear V2 Resins)
Non-sensitizer	Non-sensitizer (for BioMed Clear and dental LT Clear V2 Resins)
Non-Irritant	Non-Irritant (for BioMed Clear and dental LT Clear V2 Resins)
Non-Irritant (oral mucosal)	Non-Irritant (for BioMed Clear and dental LT Clear V2 Resins)
No evidence of systemic toxicity	No evidence of systemic toxicity (for BioMed Clear and dental LT Clear V2 Resins)
Macroscopic reaction not significant compared to negative control	Macroscopic reaction was not significant as compared to the negative control article (for BioMed Clear and dental LT Clear V2 Resins)
Non-Toxic	Non-Toxic (for BioMed Clear and dental LT Clear V2 Resins)
Absence of Pyrogens	Absence of Pyrogens (for BioMed Clear and dental LT Clear V2 Resins)
Non-Mutagenic	Non-Mutagenic (for BioMed Clear and dental LT Clear V2 Resins)

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

Not applicable. No clinical test set or data provenance from human subjects is mentioned as human clinical studies were not deemed necessary. The biocompatibility tests were likely performed in laboratories using standard animal models or in-vitro methods.

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 applicable. No clinical test set requiring expert ground truth establishment was conducted.

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

Not applicable. No clinical test set requiring adjudication was conducted.

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 an intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a physical intraoral appliance, not an algorithm.

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

For biocompatibility testing, the "ground truth" is established by the accepted scientific standards and methodologies defined in the cited ISO and USP standards (e.g., cell viability in cytotoxicity, skin reaction in sensitization, etc.). These are objective laboratory measurements, not expert consensus or clinical outcomes data in the context of device performance for snoring/sleep apnea.

8. The sample size for the training set:

Not applicable. No algorithm or AI model was developed for this device, so there is no training set.

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

Not applicable. There is no training set.

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