(58 days)
The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.
The Respironics Custom I 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 and patients who have obstructive sleep apnea. The Custom I Device is fit by a trained dentist. The device is fit by boiling the device then custom fitting it into the patient mouth by biting on the device. Like its predicate, the Silencer (K95430), the Custom 1 Oral Appliance is intended to treat patients who snore and who have obstructive sleep apnea.
The acceptance criteria and study proving the device meets them are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No impact on the safety and effectiveness of the device due to modifications. | Design verification tests were performed and all tests were verified to meet the required acceptance criteria. The modifications have no impact on the safety and effectiveness of the device. |
| Compliance with "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA," November 2002. | The modified device complies with this guidance document. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a separate test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study. The summary references "design verification tests" as the basis for meeting acceptance criteria related to safety and effectiveness. This suggests an engineering or bench testing approach rather than a clinical trial with human subjects for efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The document does not describe a clinical study involving ground truth established by experts for a test set. The evaluation seems to be based on design verification.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or a comparison of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The device is a physical oral appliance, not an algorithm or AI system. Therefore, a standalone algorithm performance study is irrelevant.
7. Type of Ground Truth Used:
The ground truth for demonstrating device performance appears to be based on successful completion of design verification tests which confirm the device's functional integrity and that modifications had no impact on safety and effectiveness. This is implicit rather than an explicitly stated ground truth for clinical efficacy.
8. Sample Size for the Training Set:
Not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a device of this nature.
§ 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.”