(137 days)
The Double Springers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
The provided text is a 510(k) summary for a natural rubber latex condom. It does not contain any information about a study with acceptance criteria and device performance data for an AI/ML powered device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, or training set information.
The document discusses the device's proprietary name ("Double Springers"), common name ("Latex Condom"), classification, and intended use for contraception and prophylactic purposes. It also mentions that the condom design conforms with ASTM Latex Condom Standard D 3492 and is a patented design (US Patent No: 5,836,308) with a special design to enhance acceptability.
The FDA's letter (pages 2-3 of the provided text) confirms the substantial equivalence of the "Double Springers" condom to legally marketed predicate devices, allowing it to proceed to market. It also provides guidance on labeling requirements for latex condoms regarding expiration dating.
In summary, this document is for a traditional medical device (latex condom) and does not involve AI/ML technology or studies related to its performance against acceptance criteria in an AI/ML context.
§ 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.