(130 days)
The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives.
The provided document is an FDA 510(k) clearance letter for a medical device: Remed Pharma Male Latex Condom (Extra Strength). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device. This letter is for a traditional medical device (condom) and primarily addresses regulatory clearance based on substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, or effect size with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a 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.