(107 days)
The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
The Consumer Health Products SnoreRx NS 9.0 is an intraoral device used at night to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. 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. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep
The provided text describes the SnoreRx NS 9.0 device, its intended use, a comparison to predicate devices, and the results of non-clinical performance testing. However, it explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a study proving the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or relied upon for this submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed or cited for the SnoreRx NS 9.0 to evaluate its performance against specific acceptance criteria for snoring reduction, this table cannot be generated. The document focuses on non-clinical performance (biocompatibility and material characterization).
| Acceptance Criteria Category | Acceptance Criteria (from a clinical study) | Reported Device Performance (from a clinical study) |
|---|---|---|
| Clinical Efficacy (Snoring Reduction) | Not applicable; document states "This submission does not rely on clinical data" | Not applicable; no clinical data provided for SnoreRx NS 9.0 efficacy. |
| Biocompatibility | Non-cytotoxic | Passed ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells (Non-cytotoxic) |
| Bian-irritant | Passed ISO Intracutaneous Irritation Test (Non-irritant) | |
| Sensitization | Negative for evidence of sensitization | Passed Guinea Pig Maximization (Negative for evidence of sensitization) |
| Material Equivalence | Materials identical to predicate device | Material characterization testing concluded materials are identical to listed predicate device. |
| Dimensional Conformance | Not specified (general testing mentioned) | Performed |
| Visual Inspections | Not specified (general testing mentioned) | Performed |
| Design Verification (Airway Passage Equivalency) | Not specified (general testing mentioned) | Performed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable, as no clinical efficacy study was conducted.
- Data Provenance: Not applicable, as no clinical efficacy study was conducted.
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):
- Not applicable, as no clinical efficacy study with a ground truth was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical efficacy study with expert adjudication was conducted.
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 anti-snoring mouthpiece, not an AI-assisted diagnostic or imaging device used by "human readers."
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 (expert consensus, pathology, outcomes data, etc):
- Not applicable, as no clinical efficacy study with a ground truth was conducted. For the non-clinical tests, the "ground truth" is established by the standard protocols of the ISO tests performed (e.g., cell viability for cytotoxicity, skin reaction for irritation).
8. The sample size for the training set:
- Not applicable, as no machine learning algorithm or clinical training data was used for this submission.
9. How the ground truth for the training set was established:
- Not applicable, as no machine learning algorithm or clinical training data was used for this submission.
In summary: The submission for the SnoreRx NS 9.0 relied on demonstrating substantial equivalence to predicate devices based on intended use, design, operating principle, mechanism of action, and technological characteristics. Non-clinical performance data (biocompatibility, material characterization, dimensional conformance, visual inspections, and airway passage equivalency) were provided to support the device's safety and fundamental function, but no clinical data or studies proving its efficacy in reducing snoring were included or deemed necessary for this 510(k) clearance.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”