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Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.

OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.

The provided text describes a 510(k) premarket notification for a medical device (OASIS® Dry Mouth Relief Discs OR OASIS® Mouth Moisturizing Discs). It is a submission for a substantially equivalent device, not a new device requiring extensive clinical trials with acceptance criteria and performance studies in the way a novel AI/software medical device would.

Therefore, many of the requested categories (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. This document focuses on demonstrating similarity to already cleared devices.

Here's a breakdown of what is available from the provided text, aligning with the spirit of your request where possible, and indicating N/A where information for AI/software device studies is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices with a similar intended use and technological characteristics. The criteria are thus implied by the characteristics of the predicate devices and the safety/effectiveness assessment by the FDA.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable for this type of submission. This is not a study comparing the device to a control group or assessing its performance on a dataset of clinical cases in the way an AI/software device would. The evaluation is based on functional and performance assessment and comparison to predicate devices.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this device submission.

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

• Not applicable.

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/software device that assists human readers.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable in the typical sense. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate devices and the consistency of the new device's characteristics with those predicates and known medical principles regarding dry mouth relief.

8. The sample size for the training set

• Not applicable. There is no training set for this type of device.

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

• Not applicable.

Study that proves the device meets the acceptance criteria:

The provided text states: "Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory."

This statement, combined with the detailed comparison to predicate devices (Section 6, Table provided), constitutes the "study" or evidence demonstrating that the device meets the implied acceptance criteria for a 510(k) submission. The FDA, by issuing the 510(k) clearance, concurred that the device is substantially equivalent to legally marketed predicate devices and therefore is considered safe and effective for its intended use. The actual details of the "functional and performance evaluation" are not provided in this summary document, as is typical for 510(k) summaries which often highlight conclusions rather than raw data.

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