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The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.

The BillyBoy condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is Cylindrical. These condoms have a length of 175 -185mm ±10mm, a width of 52.0 -55.0 mm ±2.0mm. The thickness is 0.04-0.08 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm². The primary packaging material is a foil package. The on surface lubricant is silicon oil.

The provided document describes the acceptance criteria and a study demonstrating that the Billy Boy Male Latex Condoms meet those criteria, primarily through compliance with ASTM D3492.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Billy Boy Male Latex Condoms are defined by their compliance with ASTM D3492, which is the standard for male latex condoms. The reported device performance is that the condoms passed all required specifications of this standard.

Additionally, specific dimensional characteristics are detailed and compared to predicate devices for substantial equivalence:

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

The document states that "BillyBoy condoms were tested to the standard and passed all required specifications." However, it does not specify the sample size used for this functional testing.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as the device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for condom performance is established by objective physical testing against a recognized standard (ASTM D3492).

4. Adjudication Method for the Test Set

This information is not applicable for physical device testing against a standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable as this is not an AI/imaging device.

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

This information is not applicable as this is a physical device and not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective performance measurements against established engineering and material standards, specifically ASTM D3492 for male latex condoms. This standard covers physical properties such as dimensions, air burst pressure and volume, and biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI device that requires a training set. The manufacturing process of condoms involves quality control and testing, but these are not referred to as "training sets" in the context of AI.

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

This information is not applicable as this is not an AI device.

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