Search Results

The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.

This 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 flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. The irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.

The provided document describes a 510(k) summary for BillyBoy Dotted (Beaded) Condoms and BillyBoy New Condoms. This summary focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a device meets acceptance criteria through a clinical study with human or image data. Therefore, many of the requested categories regarding clinical studies, expert involvement, and ground truth are not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that the device's performance was evaluated against specific standards. The acceptance criteria are essentially defined by these standards, and the reported performance is "passed all."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample size used for the performance testing. It generally refers to "the devices" being evaluated.
• Data Provenance: The testing was conducted by MAPA GmbH in Zeven, Germany. The data provenance is from internal testing reports and certificates. The studies were likely prospective, as they involved testing newly manufactured condoms to ensure compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device (condom), and its performance is assessed against engineering and biological standards, not through expert consensus on medical images or diagnoses.

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

Not applicable. Performance testing for condoms involves objective measurements and adherence to specifications, not adjudications by experts.

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

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device's performance is established by the specified requirements and methodologies outlined in the ASTM D3492 standard for male latex condoms and the ISO 10993 standard for biocompatibility. These standards define the acceptable physical and biological properties.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. No training set exists for this device.

Ask a specific question about this device

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.

Ask a specific question about this device