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The O2Vent T 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.

Device Description

The Upper Tray 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, is made from medical grade titanium
The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement.
The Upper and Lower Trays have a "landing area" customized to the patient's teeth and made from medical grade polymers.
The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position.

AI/ML Overview

The O2Vent T device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify numerical acceptance criteria for clinical performance (e.g., reduction in AHI or snoring scores). Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to predicate devices (OVENT and TAP-III) through non-clinical testing and shared intended use, technological characteristics, safety, and effectiveness.

Feature	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (O2Vent T)
Intended Use	Reduce/alleviate snoring and mild to moderate OSA.	The O2Vent T is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
Target Population	Adults 18 years and older.	Adult patients 18 years and older.
Environment of Use	Home Use and Sleep Laboratories.	Home Use and Sleep Laboratories.
Device Functionality	Repositions lower jaw forward, increases pharyngeal space, permits oral breathing, retains teeth using rigid trays.	Repositions the lower jaw forward. Acts by increasing the pharyngeal space to improve the patient's ability to exchange air. Permits patient to breathe through their mouth. Retains the top and bottom teeth using rigid trays.
Device Design	Customized for each patient in a dental laboratory.	Customized for each patient in a dental laboratory.
Adjustment	Adjustable by clinician and/or patient.	Can be adjusted by the clinician and patient (via a screw mechanism, without requiring additional impressions or laboratory procedures, unlike some predicates).
Sterility	Non-sterile.	Non-sterile.
Biocompatibility	Meets ISO10993 Part 5 and Part 10 standards for patient contact materials.	Biocompatibility assessment performed. Materials are identical to or similar to those in the predicate OVENT device (which passes ISO10993 Part 5 and 10), and the new connector assembly material (special grade 316 stainless steel) has no patient tissue contact and is used in the TAP-III predicate. The device is deemed biocompatible.
Mechanical Safety	Can withstand mechanical forces without significant degradation.	Can withstand mechanical forces without significant degradation.

2. Sample Size and Data Provenance for Test Set:

Sample Size: The document explicitly states: "Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent T." Therefore, there is no "test set" in the traditional sense of a clinical trial patient cohort. The evaluation relied on non-clinical testing and comparison to predicate devices.
Data Provenance: Not applicable, as no dedicated clinical test set was used.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable, as no clinical test set requiring expert ground truth was utilized. The assessment was based on non-clinical testing and regulatory comparison.

4. Adjudication Method for Test Set:

Not applicable, as no clinical test set requiring adjudication was utilized.

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

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states, "Human clinical studies were not deemed necessary." The device's approval is based on demonstrating substantial equivalence to existing legally marketed devices, not on proving improved effectiveness for human readers with or without AI assistance (as this is not an AI-assisted device).

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. This device is a physical intraoral appliance, not a software algorithm, so the concept of "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

Not applicable in the context of a clinical test set. Instead, "ground truth" for the device's characteristics and safety was established through:
- Engineering specifications and material testing: Verifying the physical and mechanical properties of the device and its components.
- Biocompatibility testing/assessment: Ensuring materials meet safety standards (ISO10993) based on predicate device data and non-contact nature of new materials.
- Comparison to predicate devices: Establishing substantial equivalence in intended use, technological characteristics, and safety/effectiveness to previously cleared devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

Not applicable. As above, this is not an AI/ML device requiring a training set and associated ground truth establishment.

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