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SleepBite is prescribed for the patient by the healthcare professional.

• A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
• B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
• C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.

SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units. The connectors between the upper and lower plates are flexible elastomeric tubes that have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.

The provided text describes a medical device called "SleepBite," a mandibular advancement device intended for anti-snoring and sleep bruxism. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

It primarily focuses on:

• Device identification: Trade name, common name, classification.
• Substantial equivalence: Comparing SleepBite to existing predicate devices (EMA and Silent Nite).
• Description: How the SleepBite device works, its adjustable screw mechanism, and flexible connectors.
• Intended Use: Specific indications for which the device is prescribed.
• Technological Characteristics: Highlighting the differences and similarities with predicate devices.
• Regulatory clearance: The FDA's 510(k) clearance letter, indicating substantial equivalence.

Therefore, based on the provided text, I cannot answer most of your questions as the information is not present in the document.

Below is a table reflecting the absence of the requested information:

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

Regarding the other questions:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The document is primarily a device description and regulatory clearance, not a clinical study report.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described.
• 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 medical device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
• 8. The sample size for the training set: Not applicable and not described.
• 9. How the ground truth for the training set was established: Not applicable and not described.

In summary, the provided document does not contain the detailed study information regarding acceptance criteria, performance metrics, or clinical trial design that your questions refer to. It is a regulatory submission focused on demonstrating substantial equivalence to previously cleared devices.

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Snore-Aid®plus is a perscribed anti-snoring device.

Snore-Aid®plus is indicated for use in patients with primary snoring A. or snoring and mild OSA (obstructive sleep apnea) where mandibular advancement and elevation of the tongue can increase a patient' s pharyngeal air space.

Snore-Aid®ø/us is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.

Snore-Aid@plus is a single plate mandibular advancement and tongue positioning orthotic consisting of: (1) a flat mandibular occlusal bite plate, (2) an adjustable external maxillary lip shield, and (3) a wide occlusal surface. The occlusal bite plate provides dental stability, protects the TMJ from occlusal loading and prevents muscle soreness due It also actively elevates and positions the tongue anteriorly to bruxism. and dorsally against the palate, thereby increasing the patency of the airway.

This 510(k) summary describes the Snore-Aid®plus device, an orthotic designed to treat snoring and mild obstructive sleep apnea (OSA) by advancing the mandible and positioning the tongue.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Snore-Aid®plus device were implicitly based on achieving a significant reduction in the Respiratory Disturbance Index (RDI) for patients with snoring and OSA. The study defined 'treatment success' as a 50% reduction in RDI and a post-treatment RDI ≤ 10.

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

• Sample Size for Test Set: 25 subjects.
• Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The country of origin is not specified but is presumed to be the USA given the FDA submission.

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

The document does not explicitly state the number of experts or their qualifications who diagnosed the snoring and OSA conditions. However, it mentions that subjects "were diagnosed with snoring and mild to severe OSA," implying a clinical diagnosis by qualified medical professionals (e.g., sleep specialists, pulmonologists). The polysomnography was read and interpreted by healthcare professionals skilled in sleep medicine.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1, 3+1, or similar. The "12 channel polysomnography" suggests objective data collection, which typically relies on established scoring rules rather than subjective adjucation for raw data. The diagnosis of OSA and RDI calculation would follow recognized clinical guidelines.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This study focuses on the device's efficacy when used by patients.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical, prescribed medical device (orthotic), not an algorithm or AI. Therefore, the concept of an "algorithm only" or "standalone" performance study, as typically applied to AI/software, is not applicable here. The study assesses the device's effectiveness in patients.

7. Type of Ground Truth Used

The ground truth for the test set was established through clinical diagnosis and objective physiological measurements.

• Diagnosis: Subjects were diagnosed with snoring and mild to severe OSA.
• Outcome Measurement: 12-channel polysomnography (PSG) was used for full-night sleep studies, providing objective data (e.g., RDI, apnea-hypopnea index) to assess the severity of OSA and the effectiveness of the treatment.

8. Sample Size for the Training Set

This document describes a clinical study on the device's efficacy, not the development of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The 25 subjects constitute the clinical study population used to evaluate the device.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, there is no training set in the AI/ML sense. The ground truth for the clinical study was established by diagnosing patients with snoring and OSA and then using pre- and post-treatment 12-channel polysomnography to objectively measure the RDI and other sleep-related parameters.

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