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The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth.

The provided text describes a 510(k) premarket notification for the SnoreRx device, which is an intraoral device for the reduction of snoring. The document primarily focuses on establishing substantial equivalence to a predicate device (SnoreRx NS 9.0) rather than presenting a detailed clinical study with pre-defined acceptance criteria and reported device performance against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The document emphasizes nonclinical testing for biocompatibility and physical properties to demonstrate that minor material differences do not raise new safety or effectiveness concerns.

Here's a breakdown of the information that can be extracted or explicitly stated as not available based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device based on technological aspects and nonclinical testing, not on clinical performance against specific acceptance criteria.

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

This information is not provided. The document describes nonclinical testing of materials, but not patient-based testing with a "test set" in the context of clinical performance.

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)

This information is not applicable/not provided. There is no mention of a "test set" requiring expert ground truth in the context of clinical performance. The evaluation is based on nonclinical material properties and a comparison to a predicate device.

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

This information is not applicable/not provided. There is no mention of a "test set" requiring an adjudication method.

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

This information is not applicable and not provided. The device is an anti-snoring intraoral device, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable and not provided. The device is an anti-snoring intraoral device, not an algorithm.

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

This information is not applicable/not provided in the context of clinical performance or a test set. The "ground truth" implicitly used for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device and the nonclinical testing of the new device's materials and design.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as the device is not algorithm-based.

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

This information is not applicable/not provided.

Summary of available information regarding compliance/testing:

The document focuses on nonclinical testing to support substantial equivalence.

• Nonclinical Testing Performed:
  • Biocompatibility Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993 and were determined to be biocompatible.
  • Physical Properties Testing:
    • Tray material: Tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62).
    • Liner material: Tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183).
  • Results: "All materials met device specifications." (Specific specifications are not detailed in this summary).

The core argument for acceptance is that the device is "substantially equivalent" to the predicate device (SnoreRx NS 9.0) because:

• They are "nearly identical in design and functionality."
• They both are mandibular repositioning devices, use a "boil and bite" method for molding, and allow jaw adjustment.
• Minor differences in material (polycarbonate resin with higher tensile strength, copolymer with slightly different durometer) and manufacturing (streamlined process, larger frontal airway opening) "do not raise any new questions of safety or effectiveness."

In essence, the "acceptance criteria" here are met by demonstrating that the new device's materials are biocompatible and meet physical property specifications, and that the overall design and intended use are sufficiently similar to a legally marketed predicate device such that no new safety or effectiveness concerns are raised. No specific clinical performance metrics (e.g., reduction in AHI, reduction in snoring incidence by a certain percentage) are presented for the new device.

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