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The MeLuna Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.

The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications. The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.

The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., sensitivity, specificity, accuracy) for the MeLuna Menstrual Cup, nor does it describe a study to prove the device meets such criteria in the context of typical AI/medical device performance evaluation.

This document is a 510(k) summary for a menstrual cup, which is a relatively low-risk medical device. The focus of the regulatory approval process for such devices is primarily on safety and substantial equivalence to a predicate device, rather than on complex performance metrics like those for diagnostic AI systems.

However, I can extract the information related to the non-clinical performance data and the overall conclusion of substantial equivalence, which serves as the "acceptance criteria" and "proof" in this context.

Summary of Acceptance Criteria and Study Findings (based on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The provided document describes non-clinical laboratory testing (biocompatibility, use-life, cleaning validation) and a comparison to a predicate device. It does not involve a "test set" of patient data or typical clinical validation with sample sizes as would be seen for AI algorithms.
• The data provenance is from laboratory testing performed according to ISO standards, not patient data from a specific country or retrospective/prospective study.

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

• Not Applicable. This type of information is not relevant to the non-clinical testing described. Laboratory tests have established protocols and endpoints, not expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. No adjudication method was used, as described above.

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 menstrual cup, a physical medical device. It is not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• For biocompatibility: ISO-10993-1:2009 (R2013) standards and their defined endpoints for cytotoxicity, sensitization, and acute systemic toxicity.
• For use-life: Presumably, established accelerated aging or physical stress test protocols to simulate 3 years of use.
• For cleaning/disinfection: Microbial reduction or other established disinfection efficacy standards.
• For substantial equivalence: Comparison against the technical characteristics and regulatory profile of the predicate device (Diva Cup).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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