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General Usage:

For the absorption/Collection and removal of excessive saliva during dental procedures.

For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.

For the absorption/Collection and removal of saliva in General Pediatric Use.

For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.

For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ...

For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.

SIMPLEX™ SALIVA ABSORBER/COLLECTOR

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, discussing the substantial equivalence of a device (Simplex Saliva Absorber/Collector) to pre-existing devices. It explicitly states that the device is of regulatory class I.

Therefore, the document does not contain information about:

• Acceptance criteria and reported device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance or adjudication methods.
• Expert qualifications or number of experts used to establish ground truth.
• Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.

The letter is a regulatory approval document based on substantial equivalence to a predicate device, not a detailed technical study report.

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