(84 days)
Dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief
The XEROS Dry Mouth Pump is a microprocessor driven device which releases small amounts of water for a user-set duration at user-set intervals. It includes a rechargeable battery, water container, pump, and pump controller. The mouthpiece is a small comfortable fitting sponge attached to 1/8" tubing. All components of the XEROS Dry Mouth Pump are placed within a waist pack. It can be worn around the waist, on the shoulder, or placed on the nightstand for example.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance.
The document is a 510(k) Notification for the XEROS Dry Mouth Pump, focusing on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and technological characteristics but does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study (like sample size, data provenance, number/qualifications of experts, adjudication methods) to prove performance against specific criteria.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Specifics about ground truth establishment for test or training sets, or training set sample sizes.
The submission focuses on comparing the XEROS Dry Mouth Pump to existing artificial saliva products (Vicks Powershot and TGO Spray) based on their intended use, method of use, application, disease state, area of use, dispensed mechanism, and presentation, stating that the data supports its substantial equivalence to these predicates. It does not present novel performance data against pre-defined acceptance criteria.
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