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TONGUE KILEAN IS INDICATED AS PART OF THE ORAL HYSIENE DALLY TO REMOVE PLAQUE FROM THE SURFACE Of THE TONGUE

Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.

The provided document is a 510(k) premarket notification for a medical device called "Tongue Klean," a tongue scraper. It primarily establishes substantial equivalence to a predicate device ("OOLITT") and details regulatory communication from the FDA.

Based on the content, here's an analysis against your requested information:

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

No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this document. The submission is for a simple, unclassified device (tongue scraper) and focuses on substantial equivalence rather than performance data from a clinical study.

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

Not applicable. No test set or clinical data is mentioned.

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. No ground truth establishment or expert involvement for a test set is mentioned.

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

Not applicable. No test set or adjudication method is mentioned.

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 a manual tongue scraper, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a manual tongue scraper, not an algorithm.

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

Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for this submission is based on the functional equivalence to a legally marketed predicate device for the purpose of removing plaque from the tongue.

8. The sample size for the training set

Not applicable. This device is a manual tongue scraper, not a machine learning model.

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

Not applicable. No training set is mentioned.

Summary of Device and Approval Context:

The "Tongue Klean" is a simple, unclassified medical device (tongue scraper) intended to remove plaque from the surface of the tongue as part of daily oral hygiene.

The approval for this device (K973175) is based on substantial equivalence to a predicate device, the "OOLITT." This means the FDA determined that "Tongue Klean" is as safe and effective as the predicate device because it has similar design, technological characteristics, and indications for use. For such a low-risk, unclassified device, extensive clinical trials or performance studies with acceptance criteria and ground truth are typically not required. The regulatory pathway relies on demonstrating that the new device is fundamentally no different in safety and efficacy than an already legally marketed device.

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