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The Lunette Menstrual Cup (Models 1, 2) 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 Lunette™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:

• Size 1 for light flow and women who have not had intercourse (diameter of 41 . mm, a height of 73 mm, and a volume of 25 ml)
• . Size 2 for heavy flow (diameter of 45 mm, a height of 78 mm, and a volume of 30 ml)
  The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. The user's guide provides information about how to use and care for the Lunette™ menstrual cup (Attachment 5).
  Lunette™ menstrual cup is a re-useable internal receptacle that is placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Lunette™ Menstrual Cup is positioned in the lower portion of the vagina. The cup does not touch the cervix or interfere with the menstrual flow through it.

This submission K091754 for the Lunette Menstrual Cup (Models 1, 2) is a 510(k) premarket notification. The device is found to be "substantially equivalent" to predicate devices, meaning it does not require new clinical studies to demonstrate safety and effectiveness.

Therefore, the submission does not contain acceptance criteria or study data demonstrating device performance in the way typically seen for novel devices requiring clinical validation.

Instead of a study proving the device meets acceptance criteria, the submission successfully argues that the Lunette Menstrual Cup is substantially equivalent to already cleared devices (Alicia™ Menstrual Cup (K070965) and Mooncup Menstrual Cup (K060852)). The basis for this determination is shared intended use, technological characteristics, and materials.

To address the specific points of your request for situations where a substantial equivalence determination is made, I will indicate why the information is not applicable or provided in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. For a 510(k) based on substantial equivalence, there are no specific performance acceptance criteria for a new clinical study. Instead, the device's characteristics are compared to those of already approved predicate devices. The submission indicates:

2. Sample size used for the test set and the data provenance

Not applicable. No new test set data from human subjects was required or provided in this 510(k) submission for substantial equivalence. The comparison is based on the characteristics of the device itself and its predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts for a test set was required for this substantial equivalence submission.

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

Not applicable. No test set requiring adjudication was present in this submission.

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 physical menstrual cup, not an AI or imaging device. Therefore, an MRMC study is irrelevant.

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

Not applicable. 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. No ground truth was required to be established for the purpose of this substantial equivalence determination. The "ground truth" for a 510(k) of this nature is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no AI component or algorithm that would require a training set.

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

Not applicable. As there is no training set, the establishment of its ground truth is also not applicable.

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