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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 O2Vent W 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 W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. 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 (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.

The provided text does not contain information about the acceptance criteria or a study proving that the O2Vent W device meets specific performance criteria. Instead, it is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's what can be extracted from the document regarding testing, and why it doesn't align with the detailed request:

1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document focuses on comparing the O2Vent W to predicate devices based on design features, intended use, and materials.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical study with a test set is described. Non-clinical testing was performed, but sample sizes for these tests are not mentioned.

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, as no ground truth for a test set is described in the context of a clinical study for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 oral appliance, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document states that "Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent W".

8. The sample size for the training set
Not applicable, as no training set for an algorithm is discussed.

9. How the ground truth for the training set was established
Not applicable.

Information that is present regarding testing:

• Summary of Non-Clinical Tests (Page 8):

  • Scope: Risk assessment of physical properties and ability to achieve intended use.
  • Preliminary Testing: Performed to confirm design can withstand forces during normal use and reasonable abuse (e.g., bruxing).
  • Results: The O2Vent W "met the specifications set." (Specific specifications are not detailed).
  • Materials: New materials (adjustment screws) are made of special grade stainless steel, have prior 510(k) approval, and are widely used in dental appliances, matching those in the predicate SOMNODENT CLASSIC device.
  • Biocompatibility: An assessment was performed. No new materials were used; all materials are already in predicate devices (O2Vent T & OVENT). Biocompatibility testing of the adjustment screws was deemed not warranted due to their source, nature, and long history of safe use in the intraoral environment. The device is considered biocompatible based on similar materials to predicate devices (O2Vent T, OVENT & SOMNODENT CLASSIC).

• Summary of Clinical Tests (Page 8):

  • Conclusion: Human clinical studies were not deemed necessary for substantial equivalence due to:
    • Designs not dissimilar from predicate devices.
    • No new technologies different from legally-marketed intra-mandibular repositioning devices.
    • No deviation from indications for use of predicate devices (O2Vent T, OVENT, SOMNODENT CLASSIC).
  • Risk Management: Risks and mitigating controls (e.g., potential for soreness) are addressed by advising patients and dentists in the "Instructions for Use," covering contraindications, warnings, precautions, storage, fitting, and adjustment.

In essence, the document confirms that the O2Vent W underwent non-clinical testing for usability and material safety, met its internal specifications for these tests, and was deemed not to require clinical studies for its 510(k) submission based on its substantial equivalence to existing devices. Specific quantitative acceptance criteria and detailed performance data from a clinical study are not provided.

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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.

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 O2Vent T is made up of three parts:

1. 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
2. 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.
3. 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.

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.

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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The OVENT is a removable medical device that is fitted in the patient 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 OVENT is for prescription use only.

The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of:
• A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth.
• A dental polymer material in each tray which is in contact with and retaining in position, the user's top and bottom teeth.
• The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user's snoring condition.
• A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.

The provided text, a 510(k) summary for the OVENT device, does not describe any clinical studies conducted to prove the device meets acceptance criteria. Instead, it explicitly states:

"Human clinical studies were not deemed necessary to evaluate the performance of the device to determine substantial equivalence as the OVENT does not:

• Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
• Use new technologies different from legally-marketed intramandibular repositioning devices for snoring and/or obstructive sleep apnea;
• Deviate from the indications for use identified in the predicate devices: the TAPIII and the LISA."

Therefore, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them, as no such study is detailed in this document.

The document does include non-clinical tests performed, such as biocompatibility and peel/bond strength testing. These tests had certain acceptance criteria, but they are not clinical performance measures.

Here's a summary of the non-clinical test information:

Non-Clinical Acceptance Criteria and Reported Performance

Regarding Clinical Studies:

• Sample size for the test set and data provenance: Not applicable, no clinical test set described.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, no clinical test set described.
• Adjudication method for the test set: Not applicable, no clinical test set described.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, no clinical study described.
• Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, device is a physical intraoral appliance, not an algorithm.
• The type of ground truth used: Not applicable, no clinical ground truth established.
• Sample size for the training set: Not applicable, no algorithm or clinical device training described.
• How the ground truth for the training set was established: Not applicable, no algorithm or clinical device training described.

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