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The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.

The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device. The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.

The ZQuiet Mouthpiece is an anti-snoring device. The study performed for its clearance was a non-clinical evaluation rather than a clinical study. The device claims substantial equivalence to its predicate device (K090503 ZQuiet Mouthpiece) based on identical intended use and design, with a material change that was tested to ensure safety.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Agar Diffusion Test: Not specified (in vitro test).
• Primary Dermal Irritation in Rabbits: Rabbits (specific number not provided but typically a small group for such tests). The data provenance is pre-clinical animal testing.
• Guinea Pig Closed Patch Sensitization Test: Guinea pigs (specific number not provided). The data provenance is pre-clinical animal testing.
• Oral Mucosal Irritation Study: Not specified (likely animal model or in vitro, but typically animal models for irritation studies). The data provenance is pre-clinical testing.

The document does not specify country of origin for the data, but these are standard international bio-compatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed were bio-compatibility and safety studies (in vitro and animal models), not human clinical studies involving expert interpretation of results. The "ground truth" was established by the scientific methodologies of the respective ISO standards and regulations.

4. Adjudication method for the test set:

Not applicable. These were laboratory tests with objective endpoints (e.g., cytotoxicity, irritation scores) rather than subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No. This was a non-clinical safety evaluation for a material change, not a study assessing diagnostic or treatment effectiveness involving human readers or cases.

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

No. This device is a physical anti-snoring mouthpiece, not a software algorithm.

7. The type of ground truth used:

The ground truth used was based on established scientific methodologies and standards for biocompatibility and safety testing (e.g., ISO 10993 standards, Federal Hazardous Substances Act Regulations). The "truth" refers to the cytotoxic, irritating, or sensitizing potential of the material under test.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. There is no training set as it's not an AI/ML device.

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The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.

The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :

• Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
• The device is made of Thermoplastic elastomer .
• ◆ May be used as supplied

Here's an analysis of the provided text regarding the ZQuiet® Mouthpiece, focusing specifically on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and subsequent FDA clearance letter. It is designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or establish novel performance criteria through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will be limited by the nature of this regulatory submission.

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., reduction in snoring decibels, AHI improvement) are not explicitly stated or provided in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard Series, K061688) based on shared intended use, materials, design, and theory of operation, implying that if the new device is substantially equivalent, it meets the inherent safety and effectiveness standards already established for the predicate.

Implicit Acceptance Criteria (based on substantial equivalence):

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The submission does not mention a clinical study with a "test set" or a comparison against a "ground truth" to establish the device's efficacy in reducing snoring.
   • The "Non-Clinical Performance Data" section only mentions "in vitro tests and animal safety studies" for biocompatibility. No sample sizes are provided for these.
   • This is typical for a 510(k) submission where substantial equivalence to a predicate device is the primary argument, rather than a de novo efficacy claim requiring human clinical trials for performance.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. There is no mention of establishing ground truth using experts for performance claims, as no performance study is described. The assessment focuses on the device's technical characteristics and safety relative to a predicate.

3. Adjudication Method for Test Set:

   • Not applicable. No test set or related adjudication process is described for performance evaluation.

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

   • No such study was done or is reported. This type of study is common for imaging or diagnostic devices where human interpretation is involved. The ZQuiet® Mouthpiece is a therapeutic device, and the submission does not involve human interpretation of data where MRMC would be relevant.

5. Standalone Performance Study (Algorithm Only):

   • No such study was done or is reported. This device is a physical medical device, not an algorithm or software. Its performance is directly tied to its physical interaction with the user's anatomy.

6. Type of Ground Truth Used:

   • For the non-clinical safety evaluation, the "ground truth" for biocompatibility would be established by standard biological safety testing protocols (e.g., ISO 10993 series), rather than clinical outcomes or expert consensus.
   • For the overall regulatory clearance, the "ground truth" is the legally marketed predicate device (SomnoGuard Series K061688), against which the new device is deemed substantially equivalent in terms of intended use, technology, and safety/effectiveness.

7. Sample Size for Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

8. How Ground Truth for Training Set was Established:

   • Not applicable. As above, no training set is relevant to this type of device and submission.

In summary: The K090503 submission for the ZQuiet® Mouthpiece is a 510(k) premarket notification. Its "study" for acceptance criteria is primarily a comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial designed to prove independent efficacy against quantitative acceptance criteria. The acceptance criteria are implicit: that the device's characteristics (components, materials, intended use, mechanism of action, design) are sufficiently similar to the predicate that it raises no new questions of safety or effectiveness. The only explicit performance data mentioned are non-clinical (in vitro and animal safety studies) to assess biocompatibility, but no details or sample sizes are provided for these.

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