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Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.

Vicks Powershot Dry Throat and Mouth Relief Liquid – For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.

Vicks Powershot Dry Throat and Mouth Relief is available for application cither as a spray or as a bulk liquid, the latter using a dispensing cup. It is a device intended for over-the-counter (OTC) consumer use. The device delivered as a spray form will be packaged in a 1.01 Fl.Oz. (30 mL) polyethylene tercphthalate (PET) plastic bottle and will be dispensed from the bottle via a positive displacement pump. The device delivered using a dispensing cup will be packaged in a 6 Fl.Oz (177mL) PET plastic bottle and will be dispensed via a polypropylene dispensing cup. The device is a clear liquid and contains polymers, including carboxymethylcellulose (CMC) that is known to coat and lubricate, as well as components that function as humectants and solvents. The device is preserved and lightly flavored for improved taste. Upon application the device coats and lubricates the mucus membrane of the mouth and oropharynx thereby providing immediate relief of dryness. The device thus functions as an artificial saliva device.

The provided text is a 510(k) Premarket Notification for Vicks Powershot Dry Throat and Mouth Relief. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive clinical study data to prove novel safety and effectiveness. Therefore, the document does not describe a study that establishes acceptance criteria for performance metrics in the way a traditional clinical trial or performance study would.

Instead, the submission focuses on comparing the new device's technological characteristics and intended use to existing predicate devices to argue for substantial equivalence.

Based on the provided text, here’s a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or corresponding performance metrics for the Vicks Powershot device. The basis for acceptance is substantial equivalence to predicate devices, which implies that its performance is considered comparable without requiring specific numerical targets beyond those inherent in the predicate's marketing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific test set or sample size for performance evaluation is mentioned. The submission relies on a comparison of device characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of experts establishing ground truth for a test set, as no such performance study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical product (artificial saliva device), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission does not describe a study involving "ground truth" establishment in the context of diagnostic accuracy. Its "ground truth" for marketing approval is its similarity to already approved devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML product, and thus no training set or ground truth for it was established in this context.

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