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K Number
K160477
Device Name
The Luco Hybrid OSA Appliance
Manufacturer
LUCO HYBRID OSA APPLIANCE INC.
Date Cleared
2016-07-29

(161 days)

Product Code
OCO,MQC
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. A device to be used for the treatment of sleep bruxism and
    1. As an aid in the treatment of associated tension/migraine type headaches in adults.
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Luco Hybrid OSA Appliance." It states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses. However, it does not contain details about a clinical study, acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily covers:

  • The FDA's decision to clear the device for marketing.
  • The device's trade name and regulation details.
  • A reminder about general controls and additional controls for Class II/III devices.
  • Contact information for FDA resources.
  • The "Indications for Use" for the device, which are:
    1. Treatment of sleep bruxism.
    2. An aid in the treatment of associated tension/migraine type headaches in adults.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

N/A