(113 days)
A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.
Latex Rubber Condom
I am sorry, but the provided documents (FDA 510(k) clearance letters and "Indications For Use" forms) do not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves a device meets those criteria.
These documents are primarily concerned with the regulatory clearance of the Durex® Ultra Comfort Latex Rubber Condoms, establishing substantial equivalence to a predicate device, and outlining its intended "Indications For Use."
The detailed information you are asking for, such as:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance
- Type of ground truth used
- Training set sample size
- How ground truth for the training set was established
...would typically be found in the premarket notification (510(k) submission itself, which includes detailed testing protocols, results, and often references to specific standards (e.g., ISO standards for condoms). The clearance letters only provide a summary of the FDA's decision based on that submission.
Therefore, I cannot provide an answer based on the given text.
§ 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.