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K Number
K180691
Device Name
TrueDorsal Devices
Manufacturer
True Function Laboratory, Inc.
Date Cleared
2019-02-11

(332 days)

Product Code
LRK
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The use of TrueDorsal® Devices are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

TrueDorsal® Device is a prescription only device that is customized by True Function Laboratory to dentist specific instructions. It is inserted and removed by the patient and adjusted by the prescribing dentist.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the TrueDorsal® Devices. It states that the device is substantially equivalent to legally marketed predicate devices for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed study specifics requested in the prompt. The letter is a regulatory clearance document, not a detailed study report.

Therefore, I cannot fulfill the request using only the provided text. The information required (acceptance criteria, study details, etc.) is simply not present in this regulatory clearance letter.

§ 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.”