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K Number
K120552
Device Name
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
Manufacturer
BIOCOSMETICS LABORATORIES
Date Cleared
2012-06-06

(104 days)

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

Formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, mouth odors and bad breath, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication.

May be used to replace normal saliva, when salivary glands are damaged or not functioning.

  • Relieves the Problems of Dry Mouth .
  • Relieving dry mouth may be effective against oral halitosis and bad breath .
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA letter regarding a 510(k) premarket notification for a device named Air-Lift/Xerostom, with indications for use related to the relief of dry mouth symptoms. It discusses regulatory compliance and substantial equivalence but does not detail any performance studies, acceptance criteria, or specific performance metrics.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth establishment, or training set size.

N/A