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The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.

The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated. The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted.

This document provides information about the acceptance criteria and supporting studies for the ONE Male Condom.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ONE Male Condom are based on various performance aspects, primarily referencing ISO 4074-15 and ASTM D3492-16. The reported device performance consistently met these criteria.

2. Sample Size for Test Set and Data Provenance

• Sample Size (Clinical Study - Test Set):
  • Enrollment: 252 MSM (men who have sex with men) and 252 MSW (men who have sex with women) were enrolled.
  • Sex Acts Analyzed: 4,884 total anal or vaginal sex acts using study condoms (2,351 anal intercourse acts, 2,533 vaginal intercourse acts).
  • Condom Samples: Each participant received 5 of each of the three condom types (standard, thin, fitted), totaling 15 condoms per participant. The "n" in the clinical failure table denotes the number of sex acts performed with each condom type.
  • Bench Testing: 125 samples of each proposed size for dimensional analysis, water leak, airburst, and freedom from holes testing.
• Data Provenance: Retrospective, conducted in Atlanta, Georgia at two sites of the Rollins School of Public Health at Emory University. The clinical study results were published in 2019 in the E Clinical Medicine Journal.

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

The provided text does not explicitly state the number of experts used to establish ground truth for the clinical study test set or their specific qualifications (e.g., radiologist with 10 years of experience).

• Ground Truth Establishment: The primary endpoint, total clinical failure (slippage, breakage, or both), was assessed through a self-administered electronic daily coital diary completed by the study participants. This indicates that the "ground truth" for clinical failure was largely based on participant self-reporting, not independent expert review of individual events.
• Study Investigators: While study investigators were involved in training participants and collecting information during biweekly visits, their role in establishing the "ground truth" for each specific failure event is not detailed beyond overseeing the data collection process. Participants and investigators were blinded to condom assignment.

4. Adjudication Method for the Test Set

The primary outcome of clinical failure (slippage, breakage, total clinical failure) was determined by self-reported data from electronic daily coital diaries completed by the participants. There is no mention of an independent adjudication method (e.g., 2+1, 3+1) for the reported clinical failure events.

• The study design followed ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male Condoms, clinical function studies based on self-reports.

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

No. This was not a multi-reader multi-case comparative effectiveness study. It was a clinical study evaluating the performance of the condom directly, not an AI-assisted detection or diagnosis device that would involve human readers. Therefore, there is no information about the effect size of human readers improving with AI vs without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a form of standalone performance was assessed through bench performance testing (dimensional analysis, water leak, airburst, freedom from holes, visible defects) where the device's physical properties were directly evaluated against specified static criteria. The clinical study, while involving human use, evaluated the device's performance directly and the "algorithm" here is the physical condom itself, without a human-in-the-loop for interpreting results.

7. Type of Ground Truth Used

• Clinical Study: The ground truth for clinical failure events (slippage, breakage) was established through participant self-report via an electronic daily coital diary. Adverse event rates were also self-reported.
• Bench Studies: The ground truth for bench performance was based on objective measurements against established standards (ISO 4074-15, ASTM D3492-16) for physical properties like dimensions, airburst pressure/volume, and freedom from holes.
• Biocompatibility: Ground truth was based on standardized in-vitro and in-vivo biological tests (e.g., MEM Elution Test, Guinea Pig Maximization, Vaginal Irritation Test, Acute Systemic Toxicity).

8. Sample Size for the Training Set

The concept of a "training set" as typically understood in AI/ML (machine learning) is not directly applicable here as this is a physical medical device, not a software algorithm being trained on data.

However, if "training set" refers to data used to inform the design and manufacturing of the condom, the context mentions:

• The device is identical in material composition and manufacturing to condoms cleared in K081886, K122219, K141059, and K150072. This implies a large historical manufacturing and testing dataset that "trained" the understanding of condom properties.
• Biocompatibility and bench performance testing leveraged data from these previously cleared condoms.

Therefore, while not a formal "training set" for an algorithm, the underlying knowledge base for the device's design and material properties is extensive, derived from a history of manufacturing and testing.

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

Again, in the context of a physical medical device, not an AI/ML model, the "ground truth" for the knowledge base that underpins the ONE Male Condom's design and manufacturing (analogous to a training set) was established through:

• Adherence to International Standards: The device conforms to ISO 4074-15 and ASTM D3492-16, which are established standards based on extensive research and consensus regarding condom safety and performance. These standards define the "ground truth" for acceptable physical properties and performance.
• Historical Data and Prior Clearances: Leverage of data from four previously cleared condom submissions (K081886, K122219, K141059, K150072). This means that previous rigorous testing (clinical, bench, biocompatibility) on structurally and materially identical condoms established the "ground truth" for their safety and effectiveness, which is now being applied to the ONE Male Condom.
• Manufacturing Experience: The accumulated manufacturing experience for these identical devices contributes to the understanding of consistent product quality and performance parameters.

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