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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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The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.

The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Premarket Notification from the FDA regarding the "American Sleep Dentistry (ASD) Oral Appliances". It primarily focuses on demonstrating substantial equivalence to existing predicate devices for the purpose of market clearance.

It describes:

• The device's trade name, regulation number, and product code.
• The device's intended use: "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older."
• A comparison of the technological characteristics (anatomic location, intended use, basic design, principles of operation, materials, manufacture) of the ASD Oral Appliances to several predicate devices.
• A detailed table comparing features like intended use, prescription/OTC use, principle of operation, design, materials, range and precision of adjustment, target population, where used, energy used/delivered, human factors, and sterility across the ASD devices and the predicate devices.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any performance studies, clinical trials, or validation test results demonstrating the device meets quantitative performance metrics.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used or how it was established.

The conclusion simply states that the new device has the "same intended use" and "same technological characteristics" as the predicate devices, thus not raising "new questions of safety and effectiveness," and is therefore "substantially equivalent." This is a regulatory determination based on comparison to existing devices, not a performance validation study.

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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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