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The Noiselezz® 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

AI/ML Overview

This document describes the marketing authorization for a medical device called Noiselezz®, an intraoral device intended for the treatment of nighttime snoring in adults. The submission is a 510(k), which means the FDA determined the device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The Noiselezz® device is seeking substantial equivalence to the ZQuiet® device (K090503). In a 510(k) submission for a device like this, the "acceptance criteria" are primarily established by demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness compared to the predicate device. The performance is assessed against these equivalency points, rather than specific numerical efficacy thresholds for snoring reduction.

Given the document, here's a table based on the direct comparisons made between the Noiselezz® and its predicate, ZQuiet®, focusing on the aspects where they are considered equivalent or where differences are justified:

Aspect / Acceptance Criteria	Noiselezz® Reported Performance / Characteristic	Comparison to Predicate (ZQuiet®)
Intended Use	Treatment of nighttime snoring in adults.	Equivalent: Both devices are C]intended for the treatment of nighttime snoring in adults.
Target Population	Adults.	Equivalent: Both target adults.
Where Used	Home or sleep laboratories.	Equivalent: Both can be used in home or sleep laboratories.
Prescription Status	Prescription device.	Equivalent: Both are prescription devices.
Device Type	Intraoral device.	Equivalent: Both are intraoral devices.
Function	Intended to reduce snoring or help alleviate snoring.	Equivalent: Both are intended to reduce or alleviate snoring.
Usage Pattern	Single patient multi-use. Placed in patient mouth each evening, cleaned daily, permits breathing through mouth, easily removed.	Equivalent: Both are single patient multi-use, placed in mouth each evening, cleaned daily, permit mouth breathing, and are easily removed.
Sterility	Non-Sterile.	Equivalent: Both are non-sterile.
Design / Components	One-piece design. Upper and lower trays fitted to patient by heating material. No occlusal notches. No saw-tag mechanism at occlusal surface.	Similar with justified differences: Both are one-piece designs. Both have upper and lower trays fitted by heating material. The Noiselezz® lacks occlusal notches and a saw-tag mechanism present in the predicate; the sponsor justifies this by stating a desire for a simpler design, reducing debris accumulation, and facilitating cleaning. This difference is argued not to raise new questions of safety or effectiveness.
Material / Biocompatibility	Thermoplastic elastomer. Cleared for: ISO 10993-5 (Cytotoxicity), ISO 10993-4 (Hemocompatibility), USP 32, NF 27 (88) Biological Reactivity Tests. Registered under FDA DMF #10824. Material specifically intended for tissue exposure (medical tubing, mucosal membrane contact).	Similar / Sufficient: The predicate device lists ISO 10993. Noiselezz® lists specific parts of ISO 10993 and USP Class VI, demonstrating comparable or more detailed biocompatibility testing. The material choice is justified for prolonged mucosal contact.
Physical Properties of Base Material	Tested for Specific Gravity (ASTM D792), Shore A Hardness (ASTM D2240), Tensile Strength (ASTM D412), Elongation (ASTM D412), Viscosity (ASTM D3835), Color.	N/A: No specific physical property metrics are provided for the predicate in this summary document, but testing the physical properties of the material is part of demonstrating safety and performance.
Safety (Shelf-life)	Evaluated through shelf-life test of the finished device.	N/A: No specific shelf-life data for the predicate is provided, but this is a standard safety evaluation for the proposed device.

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

This document primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with a "test set" in the traditional sense of a clinical trial for efficacy.

Test Set: There is no mention of a specific clinical "test set" (e.g., patient cohort for a performance study) for validating the device's efficacy in snoring reduction. The evaluation focuses on non-clinical data (biocompatibility, physical properties, shelf-life) and a comparison to the predicate.
Data Provenance: The biocompatibility and physical property testing of the base material would have been performed in a laboratory setting (in vitro tests and animal safety studies for the base material). There is no explicit mention of the country of origin for these non-clinical tests in the provided text.
Retrospective/Prospective: The non-clinical tests are prospective laboratory studies. No retrospective or prospective clinical studies on human patients are detailed in this summary.

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

Not applicable. As described above, there was no clinical "test set" involving human patients and expert assessment of outcomes for the Noiselezz® device mentioned in this summary. The "ground truth" for this submission focuses on the technical characteristics and safety of the materials, which are assessed against recognized standards by toxicologists, material scientists, and regulatory bodies (e.g., FDA for DMF and ISO standards).

4. Adjudication Method for the Test Set

Not applicable. Since no clinical "test set" with expert assessment of endpoints (e.g., snoring severity) is described, no adjudication method (like 2+1 or 3+1 consensus) is relevant here.

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 intraoral appliance to treat snoring, not an imaging device or an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to its regulatory submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this 510(k) submission relates to:

Safety and Biocompatibility: Established through adherence to international standards (ISO 10993 parts 4 and 5), USP Class VI, and FDA's own evaluation (DMF #10824 for the material).
Performance: Established by demonstrating that the device's design and materials are substantially equivalent to a legally marketed predicate device (ZQuiet®), which itself was previously cleared by the FDA for its intended use. The presumption is that if the new device is sufficiently similar and raises no new safety/effectiveness concerns, its performance will be comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. As this is a physical device submission and not an AI/machine learning algorithm, there is no concept of a "training set."

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

Not applicable. As this is a physical device submission and not an AI/machine learning algorithm, there is no concept of a "training set" or its ground truth establishment.

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