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

Trade Name: BelleCup Common Name: Menstrual Cup Device Class: II Review Panel: Obstetrics/Gynecology Product Code: HHE Regulation Number: 21 CFR 884.5400 The device is manufactured from a single component, LIM6040-D2 silicone elastomer, which is compliant with 21 CFR 177.2600 (Rubber articles intended for repeated use). The BelleCup is not supplied sterile.

The provided text describes a 510(k) submission for a medical device called "BelleCup," a menstrual cup. The submission focuses on demonstrating substantial equivalence to a predicate device, the MoonCup (K040335).

Based on the provided text, the acceptance criteria and the study that proves the device meets those criteria are not applicable in the traditional sense of a clinical performance study with specific acceptance metrics for accuracy, sensitivity, or other performance characteristics of the device itself.

Here's why and the information that is available:

• Nature of the Device: The BelleCup is a menstrual cup, a direct collection device. Its primary function is containment, not diagnosis or therapy that requires complex performance metrics.
• 510(k) Pathway: The submission is a 510(k), which generally aims to demonstrate "substantial equivalence" to a predicate device already on the market, rather than prove de novo safety and effectiveness through extensive clinical trials for performance.
• Content of the Submission: The core of this submission focuses on comparing the BelleCup's intended use, material, and sterility to the predicate device. It explicitly states "Not applicable" for both "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence" and "Discussion of Clinical Tests Performed."

Therefore, for the BelleCup, the "acceptance criteria" are essentially met by demonstrating that it is substantially equivalent to a legally marketed predicate device (MoonCup). The "study" that proves this is the comparative analysis presented in section 5, which highlights the similarities between the BelleCup and the MoonCup.

Here's the breakdown of the requested information based on the provided text:

Reported Device Performance: The device has the "same intended use and similar characteristics as the predicate device." No new questions of safety or effectiveness are raised by differences in technology or materials. (This is the conclusion of equivalence, not a direct performance metric). |
| 2. Sample size used for the test set and the data provenance (e.g., country of origin, retrospective/prospective) | Not applicable. No clinical performance test set or data provenance is mentioned. The "test" for this 510(k) is the comparison to the predicate. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not applicable. No test set requiring expert ground truth is described. |
| 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set | Not applicable. No test set or adjudication method is described. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of human readers improve with AI vs without AI assistance | Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | Not applicable. This device is not an algorithm. |
| 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) | Not applicable. The "ground truth" for this 510(k) is the established regulatory status and safety/effectiveness profile of the predicate device. |
| 8. The sample size for the training set | Not applicable. No machine learning or training set is involved. |
| 9. How the ground truth for the training set was established | Not applicable. No machine learning or training set is involved. |

In summary, the BelleCup's regulatory acceptance is based on demonstrating "substantial equivalence" to a predicate menstrual cup, the MoonCup. This involved comparing the device's fundamental characteristics (intended use, material, sterility) rather than conducting clinical performance studies with specific acceptance criteria, test sets, or expert ground truths as would be expected for diagnostic or more complex therapeutic devices. The text explicitly states that non-clinical and clinical tests were "Not applicable" for the determination of substantial equivalence in this context.

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