(271 days)
The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.
This document is a 510(k) Premarket Notification for the SancDam™ Latex Oral Dam. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a Latex Oral Dam, which is a physical barrier used during oral/vaginal and oral/anal sex to reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
The document does not describe an AI/ML-driven device or study parameters that align with the request for information on acceptance criteria and study proving device meets acceptance criteria for such a device. The tests performed are standard non-clinical bench tests for a latex barrier device.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a physical medical device, not a software or AI-based one.
No information provided in the document covers the following requested points:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types related to an AI performance study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details for an AI model.
The document focuses on non-clinical testing for a physical latex product and comparison to a predicate device for substantial equivalence, not on the performance of an AI/ML algorithm.
§ 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.