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I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) substantial equivalence determination letter from the FDA to Toaster Labs, Inc. regarding their Pulse™ Aloe-ahh product (a condom).
This letter states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, device performance metrics, study design (sample size, data provenance, expert qualifications, adjudication methods), or details about standalone/MRMC studies or ground truth establishment.
The letter is primarily focused on regulatory compliance and the substantial equivalence determination, not the specific technical details or performance study results.
§ 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.