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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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