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A patient specific mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

The Fuselier Intraoral Nighttime Device (FIND) is a patient specific oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The function of the FIND is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep.

The principle of advancing a lower tray is to advance the mandible for the treatment of night-time snoring and / or mild to moderate obstructive sleep apnea.

The information provided describes the Fuselier Intraoral Nighttime Device (FIND), which is intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients. The submission aims to demonstrate substantial equivalence to a predicate device, the Thornton Oral Appliance (TOA) (K972061).

Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed as numerical thresholds for clinical performance but are implied through the comparison to the predicate device. The performance is assessed by demonstrating similar characteristics and comparable mechanical properties.

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

• Mechanical Performance: The sample size for the mechanical performance testing (flexural and breakage strength) is not explicitly stated in terms of number of devices tested for either the FIND or the predicate. The text states "We performed flexural and breakage strength testing on the subject device and the predicate."
• Real-time Aging: The sample size for this observation was 150 patients who used the FIND in a private dental practice for over 1 year. This is retrospective observational data from a private dental practice. The country of origin is not specified, but given the FDA submission, it is likely U.S.-based.

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

There is no mention of experts establishing ground truth in the context of the performance testing as described. The clinical observation for real-time aging was conducted in a "private dental practice," implying observation by dental professionals, but specific qualifications are not provided. The study focuses on mechanical equivalence and non-clinical performance, not a clinical efficacy study with ground truth established by experts in sleep medicine.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study described that involved expert adjudication of outcomes. The testing primarily involved mechanical property comparison.

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 intraoral appliance, not an AI software or imaging interpretation tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

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

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

• For the mechanical performance tests, the "ground truth" was the measured physical properties (angle of deflection, force to damage) of the devices themselves, compared against each other, presumably using standard engineering test methods.
• For the real-time aging observation, the ground truth was the observation of "no device failures" and the maintenance of "mechanical and durability" over 1 year, as reported from the private clinical practice experience. This is essentially observational outcomes data related to device integrity.
• There was no clinical efficacy study for the FIND; therefore, ground truth related to clinical outcomes like AHI reduction or snoring alleviation (e.g., from polysomnography) was not part of this submission for the new device. The substantial equivalence relies on the predicate's established effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this type of device submission.

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The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnoea.
The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The Airwayease MAS is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnoea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of interchangeable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep.
The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement as well as vertical change to be set by the dentist or physician at the time of fitting the device.
The ranges of mandibular advancement are up to 7mm from the starting point of the construction bite supplied by the dentist, as well as 7mm of vertical opening from the starting point of the construction bite supplied by the dentist.
Lateral movement of the jaw is limited by the device and as such this device is contra-indicated for those patients requiring the ability to move their lower jaw in a lateral direction whilst wearing the device.
Vertical opening for the Airwayease MAS is unrestricted except by that of the patient's individual physiology.

The provided 510(k) summary for the "Airwayease MAS" device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a typical 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo performance study with specific acceptance criteria.

Therefore, I cannot populate the table or provide details about a study with the specific elements requested (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) because this information is not present in the provided text.

The document primarily focuses on:

• Device Description: What the Airwayease MAS is and how it functions.
• Intended Use and Target Population: Who the device is for and what it treats.
• Material Composition: Details about the materials used and their prior clearance/biocompatibility.
• Comparison to Predicate Device: A detailed comparison table highlighting similarities and differences with existing devices (SomnoMed MAS flex K0703004, OASYS K030440, TAP III K062951).
• Substantial Equivalence Claim: The core argument for 510(k) clearance, stating that differences in materials do not significantly affect safety or effectiveness.
• FDA Clearance Letter: Official communication from the FDA confirming clearance based on substantial equivalence.

In summary, none of the requested study design and results information is available in the provided text.

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The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The provided document is a 510(k) Premarket Notification for the SomnoMed MAS Flex "S" device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense for algorithm performance.

Here's an analysis based on the information provided and how it relates to your request:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices.

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

There is no test set sample size mentioned as this document does not describe a clinical study comparing the device's efficacy in a patient population against a gold standard for snoring or sleep apnea reduction. The submission is focused on material changes and confirming safety/equivalence through bench testing.

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. There was no human expert evaluation of a test set for clinical performance mentioned. The ground truth, in the context of a 510(k) for a modified device, is primarily the established safety and effectiveness of the predicate device for its intended use, and the demonstration that the material change does not negatively impact this.

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

Not applicable. There was no test set requiring expert adjudication.

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 (intra-oral appliance), not an AI algorithm, and therefore an MRMC study is not relevant to its evaluation.

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)

The "ground truth" in this context is the established safety and effectiveness of the predicate device (SomnoMed MAS K020592) for treating snoring and mild to moderate obstructive sleep apnea, combined with bench testing data (biocompatibility, product strength) on the new material to demonstrate it does not compromise these aspects.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve a training set for an algorithm.

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

Not applicable. This is a physical device and does not involve a training set for an algorithm.

In summary:

This 510(k) notification is for a modification to an existing physical medical device, primarily involving a change in catch material. The "study" referenced is bench testing to confirm the new material's biocompatibility and product strength, and a comparison table to demonstrate that the new device retains all functional attributes and indications for use of the predicate device. The primary "proof" is the demonstration of substantial equivalence to an already legally marketed device, not a new clinical efficacy trial for the device's therapeutic effect.

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