(151 days)
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 does not describe specific acceptance criteria and detailed study results in the common format of medical device clinical trials (e.g., sensitivity, specificity, or performance metrics against a numerical threshold). Instead, this document is a 510(k) summary for a re-submission of an existing device (SnoreRx) to change its classification from prescription use to Over-The-Counter (OTC) use, based on substantial equivalence to its own predicate device.
The "studies" mentioned are primarily non-clinical and related to demonstrating usability and safety for OTC use, rather than proving performance against specific clinical or diagnostic metrics.
Here's an attempt to extract and frame the information requested, with notable limitations due to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | - Cytotoxicity (ISO 10993) |
- Irritation (ISO 10993)
- Sensitization (ISO 10993) | All materials "determined to be biocompatible in accordance with ISO 10993." |
| Material Properties | - Flexural modulus & strength (ISO 178) - Stress & strain at break (ISO 527)
- Water absorption (ISO 62)
- Melting point (ISO 3146)
- Density & melt flow rate (ISO 1183) | "All materials met device specifications." |
| OTC Usability & Safety | - User's understanding of device labeling and Instructions for Use (IFU) in an OTC environment. - Ability of OTC consumer to appropriately prepare, fit, and adjust the SnoreRx without professional assistance.
- Low incidence of tooth movement, breakage, and other side effects for intraoral devices (retrospective review). | "A human factors assessment was also performed for the use of SnoreRx in the OTC environment."
"A usability study was performed to assess the OTC consumer's understanding... and to demonstrate that the OTC consumer can appropriately prepare, fit, and adjust the SnoreRx without assistance from a dental professional."
"A retrospective study was conducted to gain insight on the user's experience with the predicate device, including incidence of tooth movement, breakage, and other side effects..." |
| Substantial Equivalence | No substantial new questions of safety or effectiveness are raised by the OTC indication for use compared to the predicate. | "The OTC indication for use does not raise substantial new questions of safety or effectiveness. Therefore, the new device (SnoreRx) is determined to be substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
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Retrospective Study (User Experience with Predicate Device): Not specified.
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Human Factors Assessment: Not specified.
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Usability Study (OTC Consumer): Not specified.
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Data Provenance: Not explicitly stated (e.g., country of origin). The retrospective study was for "gain insight on the user's experience with the predicate device," implying existing data, likely from real-world usage. The human factors and usability studies were likely prospective, specifically designed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in the document. The studies conducted are primarily focused on material properties, biocompatibility, and user usability for an OTC product, not on diagnostic accuracy requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided. The studies detailed do not appear to involve complex interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an intraoral appliance to reduce snoring, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
No, a standalone algorithm performance study was not done. This device is a physical intraoral device, not a software algorithm.
7. The Type of Ground Truth Used
- Biocompatibility & Material Properties: Ground truth was established by adherence to recognized international standards (ISO 10993, ISO 178, ISO 527, ISO 62, ISO 3146, ISO 1183) and meeting internal "device specifications."
- OTC Usability: "Ground truth" for usability would be the objective assessment of whether participants could successfully perform the tasks (prepare, fit, adjust) and understand the IFU, typically measured by task completion rates and comprehension scores.
- Retrospective User Experience: "Ground truth" was the reported incidence of adverse events (tooth movement, breakage, other side effects) from users of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no "training set" as the device is not an AI algorithm requiring machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as above.
§ 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.”