(270 days)
The device is intended to aid in the reduction of snoring for adults at least 18 years old.
The Anti-Snore Mouthguard+ is a thermoforming mandibular advancement device to reduce snoring. The device works by pulling the lower jaw forward. As such, the entirety of the device is tissue-contacting. The device combines an upper and lower molding with thermal impression material to conform to user's teeth morphology with an adjustable mechanism to position the user's lower jaw according to the user's need. The Anti-Snore Mouthguard+ is a "Boil and Bite" device where both the upper and lower moldings are constructed out of moldable material when heated in a water bath with rigid frames that allow for the straps to be attached to adjust the fitting. The device additionally comes with a ventilated storage box and Instructions for Use. This ventilated storage box is only provided for storage when the device is not in use and does not impact intended use of the device.
The provided text is a 510(k) summary for a medical device (Anti-Snore Mouthguard+). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain the kind of detailed information about acceptance criteria, specific study design (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or multi-reader multi-case studies that would be expected for a software-based AI/ML device study.
The testing performed for this device appears to be primarily related to the physical properties and functionality of a mechanical device, rather than the performance of an AI algorithm. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists "Strap Tensile Testing," "Validation of Temperature Indicator," and "Force Measurement and Mandibular Advancement Testing." These are mechanical/physical tests. There is no mention of an AI component or software that would require the type of rigorous validation usually seen for AI-enabled medical devices.
Therefore, I cannot extract the requested information about acceptance criteria and study details related to an AI/ML device's performance from this document. The questions posed in your prompt (e.g., "Number of experts used to establish the ground truth," "Multi reader multi case (MRMC) comparative effectiveness study," "Standalone (i.e. algorithm only without human-in-the loop performance)") are relevant to AI/ML device validation, but the provided text does not describe a study involving an AI/ML component.
To answer your request based on the provided text, I must state that the document does not contain the specific information you are asking for, as the device described is not an AI/ML device.
§ 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.”