(45 days)
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."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3492 (tensile force, elongation, tensile strength (before and after aging), bursting volume, bursting pressure, freedom from holes, microbiological cleanliness, length, wall thickness, visual characteristics) | Passed all |
| ISO 10993 (Biocompatibility) | Compliant with ISO 10993 |
| FDA's guidance for male latex condoms | Test plans developed to meet specified requirements |
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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.