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Kimberly-Clark* U by KOTEX Click* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The tampon component is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons, formatted according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set of the preclinical or effectiveness studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies listed (e.g., biocompatibility tests, syngyna absorbency) are laboratory-based tests with objective criteria, rather than expert-driven assessments requiring a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are laboratory-based and do not involve human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or implied. The submission is for a modification (new applicator colors) to an already legally marketed device, and the focus is on demonstrating equivalence through preclinical and performance tests, not on improving human reader performance with AI.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a physical menstrual tampon and not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria mentioned generally refers to:

• Established biological responses/endpoints: For biocompatibility tests (e.g., cell viability for cytotoxicity, inflammatory response for irritation/sensitization, systemic effects for toxicity).
• Standardized physical measurement: For syngyna absorbency, the ground truth is a specific absorbency value determined by the standardized test method outlined in 21 CFR § 801.430.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm that requires a training set. The existing device (predicate) serves as a basis for substantial equivalence for the modified device.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

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