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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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