(90 days)
The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
The Apnea Sciences Corporation ApneaRx is an intraoral device used at night to reduce mild to moderate obstructive sleep apnea, and/or snoring by advancing the lower jaw (mandibular repositioning) 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ApneaRx device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain explicit performance-based acceptance criteria for the ApneaRx device related to its intended use (reduction of mild to moderate obstructive sleep apnea and/or snoring). Instead, the performance testing focuses on non-clinical evaluations for safety and material characteristics to demonstrate substantial equivalence to predicate devices.
Therefore, the table will reflect the non-clinical tests conducted.
| Acceptance Criteria (Implicit from Non-Clinical Tests) | Reported Device Performance (Test Result/Conclusion) |
|---|---|
| Biocompatibility: | |
| Non-cytotoxicity (ISO MEM Elution Assay) | Passed. Non-cytotoxic |
| Non-irritancy (ISO Intracutaneous Irritation Test) | Passed. Non-irritant |
| Non-sensitization (Guinea Pig Maximization) | Passed/Negative for evidence of sensitization |
| Material Characterization: | |
| Material identity to predicate device | Concluded that materials are identical to listed predicate device. |
| Dimensional Conformance: | Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary). |
| Visual Inspections: | Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary). |
| Design Verification (Airway Passage Equivalency): | Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Clinical Data: This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."
Therefore, there is no test set of clinical data (patients, images, etc.) to evaluate device performance regarding its effectiveness in reducing sleep apnea or snoring. The tests performed are non-clinical (biocompatibility, material characterization, dimensional conformance, visual inspections, design verification). The sample sizes for these non-clinical tests are not specified in the summary but would typically involve laboratory samples of the device materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
As no clinical data was used and the submission explicitly states no reliance on clinical data for substantial equivalence, no experts were used to establish ground truth for a clinical test set.
4. Adjudication Method for the Test Set:
Since there was no clinical test set requiring expert evaluation of clinical outcomes, no adjudication method was used. The non-clinical tests have pass/fail criteria based on standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states it does not rely on clinical data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the ApneaRx is a physical oral appliance, not a software algorithm or AI-driven device. Its performance is inherent in its physical design and material properties, rather than an "algorithm-only" functionality.
7. The Type of Ground Truth Used:
The ground truth used for the non-clinical performance data can be described as:
- Standard-based criteria for biocompatibility: The "ground truth" for these tests (cytotoxicity, irritation, sensitization) is defined by the passing criteria outlined in the respective ISO 10993 standards.
- Reference material comparison: For material characterization, the ground truth is the chemical and physical properties of the materials used in the predicate device.
- Engineering specifications/design parameters: For dimensional conformance, visual inspections, and design verification (airway passage equivalency), the ground truth would be the device's design specifications and established engineering parameters.
8. The Sample Size for the Training Set:
This question is not applicable. The ApneaRx is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for a machine learning model.
§ 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.”