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1. AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA
2. For the treatment of SNORING
3. For the prevENTION OF DRUKIEM.

The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.

This document is a 510(k) summary for the Full Breath Sleep Appliance. The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism.

The key information provided includes:

• Acceptance Criteria and Device Performance: Not explicitly stated as acceptance criteria in the prompt's sense. However, the device is considered substantially equivalent to predicate devices, implying it meets similar performance expectations. The efficacy is based on its design incorporating features from existing devices known to achieve these indications.
• Sample Size and Data Provenance: No specific study data, sample size, or provenance (country of origin, retrospective/prospective) is provided in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices rather than new clinical trials.
• Ground Truth Establishment: Not applicable as no new clinical study validating performance against a ground truth is presented.
• Expert and Adjudication Methods: Not applicable as no new clinical study validating performance against a ground truth is presented.
• MRMC Comparative Effectiveness Study: Not performed or reported in this document. The submission is not related to assessing AI assistance.
• Standalone Performance: Not applicable as this is not a standalone algorithm, but a physical medical device.
• Type of Ground Truth: Not applicable, as detailed above.
• Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI/algorithm-based device requiring a training set.

Summary of Device Performance (Implied by Substantial Equivalence):

The Full Breath Sleep Appliance (AB and ABB) is described as a simple enhancement to existing predicate devices (Quiet Night & Quiet Night MA - K032410, and NTI - K010867). Its design incorporates the anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancement for reduction/elimination of snoring, similar to the NTI. It also includes a posterior trans-palatal bar, which is stated to prevent tongue sealing against the palate, reduce snoring, and restrain the tongue from up and back movement, leading to "reduced AHI/RDI's and reduction of ODI's."

Predicate Device Comparison Table:

Note: The FDA's 510(k) clearance process involves demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that explicitly define acceptance criteria and studies to meet them in the manner described in the prompt for AI/algorithm-based devices. The "study" in this context is the comparison to existing, approved devices and the rationale for how the new device's design achieves similar intended effects.

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OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:

• Lower tray fitted over the lower teeth.
• Upper shield fitting in front of upper anterior teeth.
• Upper molded splint fitted over upper teeth.
• Connecting mechanism joining upper shield and lower tray.
• Extensions off shield which act as nasal dilators.

The provided document for the "OASYS-ORAL AIRWAY SYSTEM" (K030440) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

The document primarily highlights the device's technical characteristics and intended use, comparing them qualitatively to predicate devices. There are no quantifiable performance metrics, sample sizes, expert ground truth details, or statistical analyses typically associated with proving acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions quantitatively based on the information provided. The document specifically states: "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." This implies reliance on existing knowledge and predicate device performance rather than dedicated efficacy studies for this specific device in this submission.

However, I can extract information related to the device's intended use and the comparison to predicate devices, which implicitly serves as the "acceptance criteria" in a 510(k) context – demonstrating that the new device is as safe and effective as existing legally marketed devices.

Summary of Information from the Provided Document (K030440):

Since no specific acceptance criteria with quantifiable metrics and associated study data are presented in this 510(k) summary, I will interpret "acceptance criteria" in the context of a 510(k) submission as the attributes and intended uses for which the device needs to demonstrate substantial equivalence to its predicates. The "reported device performance" would then be its conformance to these attributes and uses as stated in the comparison.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not mention any specific test set, sample size, or data provenance from a study conducted for this device. The submission relies on demonstrating substantial equivalence to predicate devices and general literature support for oral appliances.

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)

No test set is described, and therefore, no information is provided regarding experts or their qualifications for establishing ground truth.

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

No test set is described, and therefore, no information on adjudication methods is provided.

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

No MRMC study was conducted or reported in this 510(k) submission. This is not an AI-assisted device.

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

No standalone algorithm performance study was conducted or reported. This device is a mechanical oral appliance, not an algorithm.

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

No specific ground truth type is mentioned as no dedicated study data is presented for this device's performance. The submission relies on the established safety and effectiveness of predicate devices and general scientific literature on oral appliances for snoring and sleep apnea.

8. The sample size for the training set

No training set is described, as this is a mechanical device submission and not an AI/algorithm submission.

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

No training set is described, and therefore, no information on how ground truth was established for a training set is provided.

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The Breathe EZ Anti-Snoring Device is intended to reduce or alleviate snoring and to prevent bruxing, clenching and grinding of the teeth while sleeping.
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.

The Breathe EZ Anti-Snoring/Anti-Grinding Device is composed of:

• · An oval plate fitted in front of and between the upper and lower teeth and gums.
• A port to facilitate normal breathing

The provided text is a 510(k) premarket notification for "The Breathe EZ" anti-snoring device. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain specific acceptance criteria for device performance or a study that rigorously proves the device meets such criteria in the way a clinical trial would.

Instead, the submission focuses on comparing the new device's features and intended use to those of legally marketed predicate devices. The "acceptance" in this context refers to the FDA's acceptance of the claim of substantial equivalence.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled by this type of regulatory document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) premarket notification for "The Breathe EZ" anti-snoring device does not present traditional acceptance criteria for performance metrics (e.g., a specific reduction in AHI, a percentage of patients achieving a certain snoring reduction). Instead, the "acceptance criteria" are implied by the FDA's criteria for substantial equivalence to legally marketed predicate devices. The device 'meets' these criteria if the FDA determines it is as safe and effective as a predicate device.

The "study" or justification for meeting these criteria is a comparative analysis against predicate devices, rather than a clinical trial demonstrating new performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Reduce or alleviate snoring
• Prevent bruxing, clenching, and grinding of teeth while sleeping
• Target Population: Adult patients
• Environment of Use: Home and sleep laboratories | The BREATHE EZ has the same intended use as predicate devices. The presence of an anti-tongue and lip obstruction component (a port/tube) facilitates an open airway, supporting the anti-snoring claim. |
  | Technological Characteristics:
• Intraoral device
• Heat-sensitive impressible material for fitting
• Custom fit
• Adjustable/refittable
• Placed in mouth each evening, cleaned daily, easily removed
• Permits user to breathe through mouth
• Non-sterile | The BREATHE EZ shares these characteristics with predicate devices (Dr. B's Mouthpiece, Marketing Technologies Inc., Nellcor Puritan Bennett Inc./Dr. Kieth Thornton). The primary difference is the design (addition of an anti-tongue/lip obstruction component: one port). |
  | Material Safety:
• Made of heat-sensitive impression material | Materials are implied to be similar to legally marketed predicate devices, none of which are sterile. |
  | No new questions of safety or effectiveness raised. | The design difference (the port for an open airway) is presented as a modification that doesn't raise new safety or effectiveness concerns, but rather enhances the function. The FDA's letter of substantial equivalence confirms this. |

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

• Sample Size for Test Set: Not applicable. This submission is a 510(k) premarket notification, which typically relies on demonstrating substantial equivalence to existing devices rather than new clinical testing with a "test set" of patients. No clinical study data with a test set is presented.
• Data Provenance: Not applicable, as no new clinical data from human subjects is provided. The provenance of information comes from comparisons to predicate devices (Dr. B's Mouthpiece – K991948, Marketing Technologies, Inc. – K963063, Nellcor Puritan Bennett Inc. – K972061, Dr. Kieth Thornton – K972061).

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

• Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for regulatory clearance is based on the established safety and effectiveness of the predicate devices as determined by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set or clinical data requiring adjudication by experts.

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

• Not applicable. No MRMC study was performed or described. This type of study demonstrates human reader performance with and without AI, which is not applicable to a physical anti-snoring device being cleared via substantial equivalence.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is an oral appliance, not an algorithm. Therefore, no standalone performance study in the context of AI algorithms was performed.

7. Type of Ground Truth Used:

• The "ground truth" for the purpose of this 510(k) clearance is the established safety and effectiveness of legally marketed predicate devices as previously determined by the FDA. The submission argues that "The Breathe EZ" shares the same intended use and similar technological characteristics, thereby making it as safe and effective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI model. Therefore, no training set for an algorithm was used.

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

• Not applicable, as there was no training set for an algorithm.

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