(163 days)
The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories. It is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.
The Dental Crafters' IST Snoring Appliance is a 2 piece upper and lower arch system designed to posture the lower jaw forward which increases the lower airway passage and alleviates snoring. It is custom-fit to a patient's teeth by a professional dentist. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) ISTplus mechanism produced by Dr Hinz Dental. The acrylic arches of the appliance are secured to the occlusal surface. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The dentist determines the position in which the lower jaw is supported in an anterior position.
The provided text is a 510(k) summary for the Dental Crafter's IST Device, an anti-snoring and obstructive sleep apnea appliance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device itself.
Therefore, the document does not contain the detailed information required to fill out your request, such as a table of acceptance criteria, specific device performance results, sample sizes for test/training sets, expert qualifications, or details about MRMC studies.
Here's a breakdown of why the information is missing based on what is provided:
1. A table of acceptance criteria and the reported device performance:
- Not found. The document states that the new device "is substantially equivalent to other legally marketed Anti-Snoring Devices" and lists predicate devices. This implies that its performance is presumed to be similar to legally marketed devices, but explicit performance criteria or a comparison table are not included in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not found. No clinical study or test set is described for the IST Snoring Appliance. Substantial equivalence claims often rely on comparison of technological characteristics and intended use, not necessarily new clinical trial data, especially for Class II devices.
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 found. As no test set is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not found. No test set or adjudication process is detailed.
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/Not found. This device is an intraoral appliance, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not found. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not found. No ground truth is described because no specific clinical performance study for the device is presented in this document.
8. The sample size for the training set:
- Not found. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on intended use, principles of operation, and technological characteristics. It does not contain a report of a specific study to prove new device performance against acceptance criteria. For such details, one would typically look for a full clinical study report or a different type of regulatory submission (like a PMA).
§ 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.”