THE STORK OTC by RINOVUM WOMEN'S HEALTH, INC

The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

Device Description

The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

AI/ML Overview

The provided text describes "The Stork® OTC," a conception assistance kit, and studies conducted to support its over-the-counter (OTC) use.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
User Understanding (Self-Selection & Labeling Comprehension)	Understanding the Indications for Use	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding the Selection of the Device	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding the Contraindications for Use	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding Warnings	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding When to Use the Device	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding Activity Limitations While Wearing the Cervical Cap	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding that the Device Does Not Guarantee Pregnancy	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
	Understanding How Long To Use the Device Without Successful Results Before Contacting a Physician	All primary endpoints for self-selection and labeling comprehension were achieved. The device description explicitly states these were met.
Physical Usability (Simulated Use)	Male Endpoints:	Male Performance:
	Correctly Place the Conceptacle on a Penis	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Correctly Remove the Conceptacle from a Penis	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Correctly Separate the Condom from the Cervical Cap	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Collect and Contain Semen Using the Conceptacle (Usability only)	Successfully completed ("All primary endpoints were achieved" for simulated use, and later confirmed "All subjects were able to use the device to collect semen").
	Female Endpoints:	Female Performance:
	Correctly Place the Cervical Cap in the Applicator	Successfully completed ("All primary endpoints were achieved" for simulated use, and confirmed "All subjects were able to...effectively position and place the Conceptacle® in the vaginal tract using the applicator, and remove the cervical cap from the vaginal tract").
	Correctly Close the Applicator	Successfully completed.
	Correctly Insert the Applicator into a Vaginal Tract	Successfully completed.
	Correctly Position the Applicator Near the Cervical Os	Successfully completed.
	Correctly Open the Cervical Cap with the Applicator	Successfully completed.
	Correctly Engage the Trigger Button to Release the Cervical Cap	Successfully completed.
	Leave the Cap in Place as Directed (Usability only)	Successfully completed.
	Correctly Avoid Sexual Activity While the Cervical Cap is in Place (Usability only)	Successfully completed.
	Correctly Withdraw Device from the Vaginal Tract	Successfully completed.
	Correctly Treat the Device as Single Use	Successfully completed.
Safety (Clinical Human Factors/Usability & Physical Examination)	No evidence of trauma or injury to the vaginal tract or cervical os during use and removal.	"These steps [collection, placement, removal] were successfully completed without any evidence of trauma or injury to the vaginal tract or cervical os." This was verified by visual inspection and physical examination by the primary investigator.
Biocompatibility	Materials are non-cytotoxic, non-irritating, and non-sensitizing.	Testing demonstrated that the Stork® OTC materials are considered non-cytotoxic, non-irritating, and non-sensitizing. Colorant safety also deemed acceptable through Colorant Leachables Testing and Toxicological Risk Assessment.
Material/Mechanical Properties	Pull strength of the withdrawal cord is met.	Bench testing demonstrated that the pull strength of the withdrawal cord was met for all systems tested.
Shelf-Life	All components function properly and according to design intent after a specified shelf life.	A 6-month shelf-life study was performed, and all components were shown to function properly and according to design intent. (Note: Data from the predicate device was used for Condom Mechanical Testing and Shelf-life for the Conceptacle itself).
Human Sperm Survival Assay (HSSA)	(Implicitly, the device should not adversely affect sperm viability).	Data from the predicate device (Focus Touch® Conception System) was used for Human Sperm Survival Assay (HSSA), implying the Stork® OTC also meets this.
Condom Mechanical Testing	(Implicitly, the condom-like sheath should meet mechanical standards).	Data from the predicate device (Focus Touch® Conception System) was used for Condom Mechanical Testing, implying the Stork® OTC also meets this.

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

The document does not specify the exact sample size for the self-selection, labeling comprehension, simulated use, or clinical human factors/usability studies. It states "All primary endpoints were achieved in all three sections of the study" and "All subjects were able to use the device." Without specific numbers, the sample size remains unknown from the provided text.
Data Provenance: The studies were described as "Performance Testing - Clinical" and "Performance Testing - Bench." These were conducted prospectively to demonstrate the device's suitability for over-the-counter use and safe application by lay users. The country of origin for the studies is not explicitly stated, but given the context of a 510(k) submission to the FDA, it's highly likely they were conducted in the United States.

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

For the clinical human factors/usability testing where safety was assessed, it states: "These endpoints were verified by visual inspection and physical examination by the primary investigator." This indicates at least one expert (the primary investigator) was involved in establishing safety ground truth.
Qualifications of the expert(s): The qualifications of the primary investigator are not explicitly detailed beyond being a "primary investigator" for a clinical study involving physical examination. It can be inferred they are a medical professional, likely a physician or gynecologist, qualified to conduct such examinations and verify safety endpoints related to the vaginal tract and cervical os.

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

The document does not detail any specific adjudication method like 2+1 or 3+1 for the user studies or the primary investigator's findings. The verification appears to have been carried out by the "primary investigator" directly. Therefore, it implicitly suggests a "none" or "single expert review" adjudication for the clinical safety aspects. For user performance, the "correctness" of actions was likely directly observed and recorded.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (conception kit), not an AI-powered diagnostic tool requiring human reader interpretation of images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

Not applicable. As stated above, this is a physical medical device and does not involve an algorithm. The testing focused on the standalone performance of users correctly applying the device without professional medical supervision.

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

For Usability and Safety: The ground truth was primarily established through direct observation of user performance (for correct steps) and physical examination by a primary investigator (for safety endpoints like trauma/injury). This constitutes a form of expert assessment of physical outcomes.
For Biocompatibility and Mechanical Testing: The ground truth was established through laboratory testing against established ISO standards and internal specifications (e.g., ISO 10993-1: 2009 for biocompatibility, specific pull strength measurements).

8. The sample size for the training set:

The document does not mention a training set for the device's studies. The studies described are performance testing (self-selection, comprehension, simulated use, clinical human factors/usability, bench testing), which are typically considered validation or verification tests rather than training data for a device or algorithm.

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

Not applicable, as no training set for the device's studies is mentioned in the provided text.

Summary

Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).