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Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

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.

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.

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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The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.

The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.

The provided text describes the 510(k) premarket notification for the Panthera Occlusal Appliance. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving the performance of a novel AI/software-driven medical device against specific acceptance criteria using a study.

Therefore, the information required to answer the prompt regarding AI/software performance, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided document.

The document states:

• "Human clinical study was not deemed necessary to support substantial equivalence." (page 7)
• "The Panthera Occlusal Appliance does not use design dissimilar from the primary predicate and reference devices, does not use new technologies different from the primary predicate and reference devices, and does not deviate from the indications for use of the primary predicate and reference devices." (page 7)

This indicates that the submission relies on demonstrating that the new device is fundamentally similar in design, technology, and indications for use to existing, legally marketed devices (predicates and references). The "bench testing" mentioned (page 7) is for physical properties and intended use, not for AI/algorithm performance.

In summary, the provided document does not contain the information requested in the prompt, as it is a 510(k) for a physical dental appliance based on substantial equivalence, not an AI/software medical device requiring performance studies against specific acceptance criteria.

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NOA SLEEP APNEA AND SNORING DEVICE is a mandibular advance device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

The NOA Sleep Apnea and Snoring Device is a customized prescription intraoral mandibular advancement device for snoring and obstructive sleep apnea intended for single-patient use by those who are 18 years or older. The device consists of CAD/CAM fabricated maxillary and mandibular splints connected by symmetrical, twin-mated posts that are customizable to allow lateral jaw movement as well as jaw opening. The series of one or more mandibular splints, and one or more maxillary splints to be exchanged with other splints in the series according to the prescriber, to titrate protrusive jaw movement according to patient comfort and needs. The described mandibular advancement is intended to reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible and base of tongue forward during sleep, to provide increased pharyngeal space to improve the patient's ability to exchange air and decrease air turbulence. The NOA Sleep Apnea and Snoring Device does not have any additional adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps, repositioning elastics or screws, eliminating the need for utilizing external controlling components such as keys, screwdrivers or ligature ties. The NOA device is designed with lateral fins called cam and follower. Contact between the cam and the follower prevents any mandibular retrusion even with the opening of the mouth. The device design is configured according to the patient's specific dental arch, to maximize tongue space and to allow open, close and laterality movements during wear. These movements can be personalized by the doctor. Furthermore, the doctor can change the height of the cam in the prescription to limit the maximum mouth opening during wear. Orthoapnea NOA device designs can be Standard or Customized. A Standard device is designed with standard height in the lateral cams among all lower splints. If the practitioner provides a measurement of the antero-posterior mobility (Maximum retrusion), a Customized device is designed decreasing the height of the cam according to the degree of advancement. increases, the ability to open the mouth without mandibular retrusion decreases, making the cam shorter. The following additional device design features can be customized when ordering the prescription device: Advance regulation/titration sequence, Lateral movement, Device opening limit, Frontal opening of the device.

The provided document is a 510(k) summary for a medical device called "NOA Sleep Apnea and Snoring Device." It outlines the device's technical characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Crucially, this document does not contain any information about an AI/ML-based device or a study involving human readers or AI assistance. The device described is a physical intraoral mandibular advancement device. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for AI/ML models, expert ground truth establishment, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

The document explicitly states:

• "No clinical testing was performed." (Page 6, Section E)
• "Non-clinical testing was used to support the determination of substantial equivalence." (Page 6, Section E)

Therefore, I cannot fulfill the request as it pertains to an AI/ML device and its validation. The document describes a traditional medical device (mandibular appliance) and its clearance process based on non-clinical bench testing and comparison to existing predicate devices.

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The O2Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.

The O₂Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
The O₂Vent Optima consists of the following parts:
Upper tray (upper teeth)
Lower tray (lower teeth)
Connector bands
The upper tray is fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance. The upper nylon tray has two side protrusions (lugs) that engage a connector that when attached, extends to the lower tray and attaches to a similar lug stabilizing and advancing the lower jaw. The lower tray, is customized to the bottom teeth, which when attached to the same connector via a side protrusion (lug) preventing the tongue and soft tissues of the throat from collapsing and obstructing the airway. In order to adjust the trays to the specific needs of the user, various length bands (13-21mm) are used to move the lower jaw (i.e. adjust the trays) forward or backward. The shorter the connector band, the further the lower jaw is moved forwards. The O2Vent Optima is delivered fully assembled with the 19mm connector band as the recommended starting titration length for all new users. The upper and lower trays of the O2Vent Optima are made with PA2200 (i.e. Nylon). The straps which connect the upper and lower trays together are made of 100% thermoplastic polyurethane/cured elastomer.

Here's a summary of the O2Vent Optima's acceptance criteria and the study information, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance:

The document provided (an FDA 510(k) summary) acts as a substantial equivalence determination, not a full clinical study report with explicit acceptance criteria and corresponding reported performance metrics (like sensitivity, specificity, accuracy, or specific reductions in AHI).

Instead, the submission argues for substantial equivalence by comparing the technological characteristics of the O2Vent Optima to predicate and reference devices. The "performance" is implicitly demonstrated through this comparison, indicating that the device is "as safe, as effective and performs comparatively" to the predicate and reference devices that are already legally marketed.

Therefore, the table below reflects the characteristics that were compared to establish substantial equivalence rather than numerical acceptance criteria and performance data.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document (510(k) summary) does not describe a clinical study of the O2Vent Optima that would involve a "test set" and a specific sample size for performance evaluation. Instead, it relies on demonstrating substantial equivalence to already cleared devices through a comparison of technological characteristics. Therefore, there is no information on sample size or data provenance from a specific test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

As no specific clinical performance study with a test set is described, there's no information regarding experts used to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no described test set or clinical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned or summarized in the provided document. The submission focuses on device characteristics, not reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The O2Vent Optima is an intraoral medical device, not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. The submission focuses on comparing the physical and functional characteristics of the device and its materials to predicate devices rather than validating an algorithm against a ground truth. Biocompatibility testing was done to established standards (ISO 10993).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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