(233 days)
The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
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This document is a 510(k) clearance letter for the "One Touch Spiral Condom" and describes its indications for use. It outlines administrative details, regulatory compliance information, and contact details for further inquiries regarding FDA regulations. However, this document does not contain information about the acceptance criteria for a device's performance, nor does it detail any study proving a device meets such criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- 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.