(106 days)
The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
Not Found
I apologize, but the provided FDA 510(k) clearance letter for the ONE Nitrile Condom does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/medical imaging devices.
The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general controls for medical devices. It outlines:
- The FDA's determination of substantial equivalence for the ONE Nitrile Condom (K243967).
- Regulatory classifications (Class II, Product Code MOL).
- Applicable regulations (e.g., Quality System regulation, UDI Rule).
- General information about FDA oversight of medical devices.
- The intended use of the device (contraception and STI prevention).
Therefore, I cannot extract the detailed information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in this specific FDA clearance letter for a condom.
These types of details are typically found in regulatory submissions for AI-enabled medical devices or diagnostic tools, which undergo rigorous performance validation studies. A condom, while a medical device, is evaluated based on different performance metrics (e.g., burst strength, freedom from holes, dimensions) that are validated through standard tests rather than AI-specific evaluations.
§ 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.