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

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The provided text is an FDA 510(k) clearance letter for the Mooncup Menstrual Cup. This document is a regulatory approval, not a scientific study describing device performance against acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document.

The document confirms that the Mooncup Menstrual Cup (K060852) has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Here's a breakdown of what is available in relation to your request, and why other parts cannot be answered from this text:

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

• Not provided. This document is an approval letter, not a performance report. It states that the device is "substantially equivalent" to predicate devices, but does not detail specific performance metrics or acceptance criteria for that substantial equivalence.

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

• Not provided. This document does not refer to a "test set" in the context of a performance study. "Substantial equivalence" typically involves comparing device features and indications for use to an existing device, rather than a clinical trial with a test set.

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/Not provided. No "ground truth" establishment for a test set is discussed. The FDA's determination is based on a review of the company's submission against regulatory requirements and comparison to predicate devices, not on an independent expert adjudication of performance data.

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

• Not applicable/Not provided. No "test set" or adjudication method is described.

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/Not provided. This device is a menstrual cup, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI performance is irrelevant to this product.

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

• Not applicable/Not provided. This device is a physical menstrual cup, not an algorithm.

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

• Not applicable/Not provided. No "ground truth" as it pertains to performance evaluation of a diagnostic or AI device is mentioned. The "ground truth" for regulatory approval in this context is the existing regulatory framework and the characteristics of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided. There is no "training set" for this device.

In summary: The provided text is a regulatory approval letter based on "substantial equivalence" to existing devices, not a study report detailing performance data against specific acceptance criteria. Therefore, most of your questions are outside the scope of this document.

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