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The Trojan XOXO Thin condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Thin condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a straight wall nipple end shape consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom). The Trojan™ XOXO™ Thin condom has a nominal length of 180 ± 10 mm, a nominal thickness of 0.07 ± 0.01 mm, and a nominal flat- width of 52 ±2 mm, measured 30 mm from the open end.

The provided text describes the 510(k) premarket notification for the Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant. It states that the device is substantially equivalent to a legally marketed predicate device (Trojan™ (TM-TBD) Latex Condom with Lubricant, K912901).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

First, it's crucial to understand that this document describes a medical device (condom), not an AI or software device. Therefore, the questions related to AI-specific elements like "test set," "ground truth," "MRMC study," "standalone algorithm performance," and "training set" are not applicable to this submission. The "device" in this context is a physical product.

Acceptance Criteria and Device Performance (Physical Testing):

The document explicitly states that the Trojan™ XOXO™ Thin condom was tested against the specifications of ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms). This ASTM standard defines the acceptance criteria for male condoms, which typically include properties like burst volume and pressure, tensile strength, elongation, freedom from holes, and dimensions.

While the document doesn't list the specific numerical acceptance criteria from ASTM D3492-08 in a table, it does state the device's performance relative to that standard.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Physical Testing: "Three (3) lots of Trojan™ XOXO™ Thin condom were tested and met specifications of ASTM D3492-08".
   • Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of rabbit subjects, guinea pigs, cell cultures) are not provided in this document. These would be defined within the respective ISO standards.
   • Data Provenance: The document does not explicitly state the country of origin, but it implies internal testing by Church & Dwight Co., Inc. and/or a contracted lab following international standards (ASTM, ISO). It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

   • Not applicable in the context of AI. For a physical device like a condom, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and ISO standards (e.g., laboratory measurements for dimensions, burst tests, biological responses). The "experts" would be the qualified laboratory technicians and scientists performing the tests and interpreting the results according to the standard protocols. Their qualifications are inherent in their ability to perform validated tests.

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

   • None in the sense of expert adjudication for an AI output. The adjudication for a physical device test involves meeting predefined numerical specifications or observed biological responses as per the established test methods.

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:

   • Not applicable. This device is a physical condom, not an AI system.

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

   • Not applicable. This device is a physical condom, not an AI system. The performance is the intrinsic performance of the physical product.

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

   • The "ground truth" for the physical characteristics and biocompatibility of the condom is based on objective, standardized measurements and observations as defined by:
     • ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) for physical properties.
     • ISO 10993 series (e.g., ISO 10993-5, -10, -11) for biological evaluation of medical devices (biocompatibility).

7. The sample size for the training set:

   • Not applicable. There is no "training set" for a physical device in the AI sense. The manufacturing process of condoms involves quality control checks throughout production, but this is not analogous to an AI training set.

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

   • Not applicable. As above, there is no AI training set. The "ground truth" for ensuring manufacturing quality aligns with general quality system regulations (21 CFR Part 820) and specifications derived from standards like ASTM D3492-08.

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