(438 days)
SKORE Natural, SKORE Dots Natural, SKORE Bulbous Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
SKORE Natural, SKORE Dots Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms.
The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for various latex condoms (SKORE Natural, SKORE Dots Natural, SKORE Bulbous Natural, and SKORE Bulbous Dots & Ribs Natural).
This document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory clearance document, confirming that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It sets forth the general controls and regulations the manufacturer must comply with.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample sizes for test sets or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details or effect size
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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.