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The Sunny Cup and Applicator is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.

The Sunny Cup and Applicator is an over the counter (OTC) medical device consisting of a reusable silicone menstrual cup with a lubricious coating and a reusable applicator with a nylon body and a thermoplastic polyurethane (TPU) tip with a lubricious coating. The Sunny Cup is a soft receptacle designed for placement within the vaginal canal to hold up to 25 mL of menstrual fluid and can remain within the body for up to 12 hours. The Sunny Cup is also designed with grip lines and a stem on the distal end to allow for easy location and manipulation of the Sunny Cup during removal.

The Applicator component enables the insertion process for the user and consists of a barrel, a pusher, and a pusher base, functioning similarly to a tampon applicator. For the insertion process, the Sunny Cup is folded and placed in the Applicator barrel. The pusher component is then used to deploy the Cup through the Applicator. The Sunny Cup then unfolds upon deployment to create a seal in the vaginal canal and collect menstrual fluid. After 12 hours, the Sunny Cup is removed manually by squeezing the grip lines to break the seal and pulling the Cup out by the grip lines along the base of the Cup. The Cup component should be cleaned via boiling at the start of each menstrual cycle, and the Cup and Applicator components should be cleaned with warm water and mild, fragrance-free soap between uses. The Sunny Cup and Applicator may be reused by a single patient for up to a year or until discoloration or damage is evident.

The provided text describes the "Sunny Cup and Applicator," a menstrual cup device, and its substantial equivalence to a predicate device, the "SckoonCup." However, the document does not contain information related to acceptance criteria, specific device performance metrics, or study details such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, outlining comparisons in technological characteristics, materials, and intended use. The performance testing mentioned is "Bench performance testing" and "Biocompatibility Testing," which verified certain aspects but aren't presented with acceptance criteria or specific quantitative outcomes in the provided summary.

Therefore, most of the requested information cannot be extracted from this document, as it is a 510(k) summary, not a detailed study report.

Here's a summary of the available information and the missing details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Bench Testing: Verified the Cup met the 25 mL volume capacity.
• Bench Testing: Verified the Cup met folding requirements throughout its use-life.
• Biocompatibility Testing: Demonstrated non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic for both cup and applicator.
• Reprocessing and Cleaning Validation: Demonstrated acceptability of cleaning procedures and ability to withstand repeated reprocessing. |

Missing Details: Specific numerical acceptance criteria (e.g., minimum force withstood, specific ranges for chemical levels, cleanliness thresholds) are not provided. The performance is reported qualitatively as "met the prespecified requirements" or "demonstrated acceptability."

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

• Sample Size for Test Set: Not specified.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Number of Experts: Not applicable, as no clinical study or expert-adjudicated test set is mentioned.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as no clinical study or expert-adjudicated test set is mentioned.

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:

• MRMC Study: No, a MRMC study was not done. The device is a physical medical device (menstrual cup and applicator), not an AI-powered diagnostic or assistive tool.
• Effect size of human readers with/without AI: Not applicable, as no AI component is mentioned.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: Not applicable, as the document describes bench testing and biocompatibility. The "ground truth" for these tests would be established by validated test methods and standards (e.g., ISO 10993 standards for biocompatibility), not clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device requiring a training set.

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

• How Ground Truth was Established: Not applicable.

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

Not Found

The provided text is a 510(k) premarket notification approval letter for the FemmyCycle® menstrual cup, not a study evaluating the performance of an AI-powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI device.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or ground truth for test or training sets.
• Details about experts, adjudication methods, or MRMC comparative effectiveness studies.
• Information about standalone algorithm performance.

The document is an FDA approval for a medical device (a menstrual cup) based on substantial equivalence to a predicate device, not on a detailed performance study with defined acceptance criteria in the context of an AI/software device.

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

SckoonCup is a soft, small silicone menstrual cup that is placed internally in the vagina. The SckoonCup is reusable and it holds menstrual flow instead of absorbing. It may remain in the body up to 12 hours. It is available in two sizes:
Size 1: Small-Women who have never given birth vaginally; Capacity 23ml
Size 2: Large-Women who have given birth vaginally; Capacity 30 ml
Material: SckoonCup menstrual cup is manufactured from a soft silicone elastomer.

The provided 510(k) summary for the "SckoonCup, Size 1 and 2" is for a menstrual cup, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (MoonCup, K040335) rather than providing extensive clinical study data related to acceptance criteria. Therefore, several of the requested sections below are not applicable to this type of submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (MoonCup, K040335) rather than establishing specific performance acceptance criteria for a novel device. The "acceptance criteria" here are implicitly related to conforming to the characteristics of the predicate device and relevant regulations.

The Study that Proves the Device Meets Acceptance Criteria

The provided document describes a 510(k) Premarket Notification submission, which is a regulatory pathway for demonstrating "substantial equivalence" to a legally marketed predicate device. This process typically relies on non-clinical testing and comparison to the predicate, rather than an extensive clinical study with human subjects, especially for a well-understood device type like a menstrual cup.

Type of Study: This is not a clinical study or a comparative effectiveness study in the traditional sense. It is a design verification and product comparison exercise to demonstrate substantial equivalence. The "study" involves:

• Material Characterization: Reviewing material properties, biocompatibility data, and manufacturing processes.
• Dimensional Comparison: Presenting and comparing physical dimensions (shape, diameter, height, capacity) to the predicate device.
• Intended Use Comparison: Clearly stating identical indications for use and duration of patient contact.
• Manufacturing Process Comparison: Highlighting similar manufacturing methods and a certified quality system.

The "proof" stems from the detailed justifications provided in the submission that the SckoonCup is "substantially equivalent in shape, dimensions, material, technological characteristics, and Indications for Use" to the MoonCup (K040335). The FDA's issuance of the 510(k) clearance (K120107) signifies their agreement with this substantial equivalence claim.

Additional Information on Study Parameters:

Given that this is a 510(k) for a menstrual cup based on substantial equivalence, many of the typical clinical study parameters (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable or are not detailed in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate.

1. Sample Size Used for the Test Set and Data Provenance:

   • N/A. There isn't a "test set" in the context of human subjects or data classification for this type of submission. The comparison is made against the specifications and regulatory clearance of the predicate device itself.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • N/A. Ground truth, in the sense of expert consensus on disease or image interpretation, is not applicable here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device as determined by its prior FDA clearance.

3. Adjudication Method for the Test Set:

   • N/A. Not applicable, as there's no clinical "test set" requiring expert adjudication.

4. 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:

   • N/A. This is not an AI-enabled diagnostic device.

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

   • N/A. This is not an algorithm-only device.

6. The type of ground truth used:

   • The "ground truth" for this 510(k) submission is the documented characteristics and safety/efficacy profile of the predicate device (MoonCup, K040335), as previously cleared by the FDA. The SckoonCup's safety and effectiveness are inferred from its substantial equivalence to this predicate.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device. The "data" used is the engineering specifications, material data, and regulatory history of both the SckoonCup and the predicate.

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

   • N/A. Not applicable for this type of device and submission.

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The Rhea 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 Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally.

The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina.

The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.

This 510(k) submission for the Rhea Cup does not contain the specific information required to complete your request for acceptance criteria and a study that proves the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The provided document is a 510(k) summary and a clearance letter. It focuses on demonstrating substantial equivalence to predicate devices based on material, intended use, and general characteristics. It does not include a table of acceptance criteria for specific performance metrics (e.g., leakage rates, comfort levels, fluid capacity in a real-world setting) nor does it report the Rhea Cup's performance against such criteria from a clinical or non-clinical study.
• No Description of a Performance Study: The document mentions that "No applicable mandatory performance standards or special controls exist for this device," which further indicates that a specific performance study against pre-defined acceptance criteria was likely not a requirement for this 510(k) clearance. Clinical data is often not required for devices cleared through the 510(k) pathway if substantial equivalence can be shown through other means (e.g., material safety data, comparison of characteristics).
• Focus on Substantial Equivalence: The entire submission hinges on comparing the Rhea Cup to predicate devices (Tassaway, BelleCup, Lunette) and arguing that it is "substantially equivalent" in materials, technological characteristics, and intended use. This is the primary "proof" for 510(k) clearance, rather than a direct performance study of the new device against acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

The document fundamentally states that due to substantial equivalence with already cleared devices, no specific performance criteria or studies were needed beyond material compatibility. The "study" proving the device met "acceptance criteria" (which aren't explicitly stated for this new device in the context of performance) was the comparison to predicate devices, demonstrating equivalence.

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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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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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The Alicia 100 Menstrual Cup / Models 99ALXS, 100ALSM, 101ALMD, 102ALLG 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 Alicia™ 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 four sizes:
· L size: 102ALLG; for larger built women that have had children.
· M size: 101ALMD; for women who have had vaginal childbirth or C-Section; and for women who are over 30 years old and never had childbirth.
S size: 100ALSM; for women under 30 years old who have never had childbirth or C-Section.
· XS size: 99ALXS; for teenagers and very small framed women.
The cup remains entirely within the vagina and does not tough the cervix but the stem remains outside the body to ensure retrieval of the cup.
The Alicia™ menstrual cup is manufactured from a soft silicone elastomer.

This 510(k) summary (K070965) for the Alicia™ Menstrual Cup does not contain the kind of detailed performance study data typically found in submissions for AI/ML-based medical devices. The device described is a physical menstrual cup, and the submission focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, intended use, and general safety standards (biocompatibility).

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are not applicable to the type of device and submission provided.

The document states:
"Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." This implies that such tests were performed, but the details are not included in the provided 510(k) summary. These details would typically be found in the full 510(k) submission, not the public summary.

Here's what can be extracted based on the provided text, heavily indicating that the prompt's requirements for AI/ML device testing are not met by this document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The provided document is for a physical medical device (menstrual cup) and does not include performance metrics or acceptance criteria in the context of an AI/ML algorithm. The "performance" assessment is based on demonstrating substantial equivalence to a predicate device, primarily through material biocompatibility and intended use.

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

Not applicable. The document does not describe a "test set" in the context of evaluating an algorithm's performance on data. The evaluation appears to be based on compliance with standards (e.g., ISO 10993) for the device's materials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of establishing ground truth for data review, as this is not an AI/ML device.

4. Adjudication Method

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical menstrual cup, not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no algorithm to test in a standalone manner.

7. Type of Ground Truth Used

Not applicable. There is no clinical "ground truth" established from data, as typically seen in AI/ML submissions. The "truth" for this device likely revolves around material safety and functional design.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set or ground truth in the context of AI/ML.

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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.

Not Found

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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