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wettrust D2care is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.

wettrust D2care is a water-based personal lubricant that is packaged in a single use prefilled one-push syringe. The primary ingredients include water, glycerin, and hydroxethylcellulose. The device specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

Here's an analysis of the provided text, focusing on acceptance criteria and the study data:

1. Table of Acceptance Criteria and Reported Device Performance

For the wettrust D2care personal lubricant, the acceptance criteria are generally established by compliance with various national and international standards. The document doesn't explicitly list "acceptance criteria" then "reported performance" side-by-side in a single table, but rather states that the device was tested in accordance with standards and demonstrated compliance.

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

The document provided does not specify the sample sizes used for the test sets for any of the non-clinical performance data. It mentions the types of tests and the standards they adhere to, but not the number of units/samples tested.

The data provenance is for a manufacturing company based in Korea (Wettrust Korea Co., Ltd.). The studies are non-clinical performance tests conducted to demonstrate substantial equivalence, which are typically prospective in nature for a new device.

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

This information is not applicable and not provided in the document. The studies performed are non-clinical, laboratory-based performance tests (e.g., biocompatibility, microbial counts, condom compatibility) against established standards. These types of tests do not involve human expert adjudication for a "ground truth" in the way a diagnostic AI study would. The "ground truth" here is the adherence to the methodologies and pass/fail criteria of the specified international/national standards.

4. Adjudication Method for the Test Set

This is not applicable and not provided. As mentioned above, these are non-clinical hardware/chemical performance tests, not studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. The device is a personal lubricant, not a diagnostic imaging device or an AI-powered tool that would typically undergo an MRMC study. The studies performed are non-clinical performance and safety tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical product (personal lubricant), not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance studies is compliance with the methodologies and acceptance criteria defined by the referenced international and national standards. For example, the "ground truth" for biocompatibility is that the device passes all tests outlined in ISO 10993-1. For condom compatibility, it's that the device meets the performance requirements specified in ASTM D7661 after exposure to synthetic polyisoprene condoms.

8. The Sample Size for the Training Set

This is not applicable as the device is a personal lubricant and not an AI/ML algorithm or software that requires a training set.

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

This is not applicable as the device is a personal lubricant and not an AI/ML algorithm or software.

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