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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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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.

The MoonCup® 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: Style A - After childbirth; Style B Before childbirth and/or C-section. 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 provided document, K040335, is a 510(k) Premarket Notification for the MoonCup® menstrual cup. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against acceptance criteria through a clinical study in the same way a PMA submission would.

Therefore, the document does not contain information about acceptance criteria, a specific study proving device performance against those criteria, sample sizes for test sets, expert ground truth establishment, or multi-reader multi-case studies.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on materials, dimensions, intended use, and indications for use.

Here's an analysis based on the information provided, noting what is explicitly stated and what is absent:

Summary of Device Acceptance Criteria and Performance (Based on K040335):

The K040335 submission for the MoonCup® menstrual cup is a 510(k) Premarket Notification. For 510(k) submissions, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative metrics through a clinical study. Therefore, the document does not present a table of acceptance criteria and reported device performance in the manner requested for a clinical evaluation.

Instead, the document asserts substantial equivalence based on the following:

Detailed Information as Requested (with emphasis on what is not present in a 510(k) for this type of device):

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

   • Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) because this is a 510(k) for a menstrual cup, which primarily relies on substantial equivalence to predicates for safety and effectiveness. The "acceptance" is the FDA's determination of substantial equivalence.
   • Reported Device Performance: The "performance" described is largely descriptive (e.g., made of silicone, holds one ounce, two sizes, reusable, placed internally for up to 12 hours) and aligns with the characteristics of the predicate devices. There are no performance metrics from a dedicated clinical study as would be seen for higher-risk devices or those requiring a PMA.

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

   • Not Applicable. The document does not describe a clinical test set in this manner. Substantial equivalence for this device is based on material properties, design, and intended use, not clinical trial data comparing performance in a patient cohort. Biocompatibility data for the silicone elastomer is referenced via a master file and MDSS, but this is material testing, not a clinical test set for performance.

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. There is no "test set" requiring ground truth establishment by experts in the context a diagnostic or imaging device. The device itself (a menstrual cup) does not generate diagnostic data that would necessitate expert adjudication for ground truth.

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

   • Not Applicable. No test set or expert adjudication related to performance metrics 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. The MoonCup® is a physical medical device (menstrual cup), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

   • Not Applicable. This is a physical device, not an algorithm.

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

   • Not Applicable. As there is no clinical test set for performance metrics, there is no "ground truth" established in this sense. The basis for safety and effectiveness is largely historical use and characterization of materials.

8. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI device. No "training set" in that context is mentioned or implied.

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

   • Not Applicable. As above, no training set or ground truth in this context is mentioned. The "truth" for substantial equivalence lies in the established characteristics and safety profile of identical or very similar predicate devices.

Conclusion Regarding the Document's Content:

The K040335 submission for the MoonCup® is a typical 510(k) Premarket Notification for a Class II medical device. It successfully demonstrates substantial equivalence to predicate devices (DivaCup™, The Keeper®, Tassaway) based on shared characteristics like materials (silicone), intended use (collecting menstrual flow), and general design principles. The FDA's letter of March 30, 2005, confirms that the device was found substantially equivalent, allowing it to proceed to market under general controls. The document explicitly states that the silicone elastomer's properties are described in a master file at the FDA, including data on biocompatibility and toxicity testing as required by FDA's G95-1 memorandum, further supporting the safety aspect. However, it does not present a clinical study with acceptance criteria and measured performance outcomes as one might expect for a novel device or a higher-risk diagnostic tool requiring more extensive clinical validation.

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