(58 days)
The Respironics Custom II Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring.
The Respironics Custom II Oral Appliance is a mandibular repositioner that is a removable dental device that is fitted in the patient's mouth that and is indicated to treat patients who snore. The Custom II Device is fit by a trained dentist. The device is fit by boiling the custom fitting it into the patient mouth by biting on the device. Like its predicate, the Silencer (K95430), the Custom II Oral Appliance is intended to treat patients who snore.
The provided text is a 510(k) Summary for a medical device called the "Respironics Custom II Oral Appliance." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states: "Design verification tests were performed on the Respironics Custom II Oral Appliance as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." But it does not list what those specific acceptance criteria were, what the reported device performance was against those criteria, or details about the studies conducted.
Here's a breakdown of what I can answer based on the provided text, and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| (The document only states "All tests were verified to meet the required acceptance criteria." It does not detail what those criteria were or the specific performance metrics achieved.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document.
- Data provenance: Not specified in the document.
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 specific human expert evaluation study is described for ground truth establishment. The device is a physical appliance, not an AI or diagnostic tool requiring ground truth from experts for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific human expert evaluation study for ground truth is described.
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
- No, an MRMC comparative effectiveness study was not done. This device is an oral appliance for snoring, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical oral appliance, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device itself is the "standalone" product that is fitted by a dentist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For a physical device like this, "ground truth" would typically relate to objective measures of effectiveness (e.g., reduction in snoring events, patient comfort, retention) from clinical studies. The document only mentions "design verification tests" were performed.
8. The sample size for the training set
- Not applicable. This device is a physical oral appliance, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical oral appliance, not an AI algorithm that requires a training set.
Summary of what the document does state regarding performance/testing:
The submission states that "Design verification tests were performed on the Respironics Custom II Oral Appliance as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This indicates that internal testing was conducted to ensure the device met its design specifications and safety requirements. However, the specifics of these tests, the acceptance criteria, and the results are not detailed in this summary document. The focus of this 510(k) is on demonstrating substantial equivalence to a predicate device, primarily based on intended use, operating principle, technology, and manufacturing process.
§ 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.”