(263 days)
Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.
Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of
This document, a 510(k) Summary for the Satisfaite™ personal lubricant, describes the process for demonstrating substantial equivalence to a predicate device, not the acceptance criteria and study proving device performance in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.
The provided text details the regulatory application for a personal lubricant, a physical product, and outlines its properties, chemical composition, and testing results to ensure it is safe and effective and comparable to similar products already on the market (predicate device).
Therefore, I cannot extract the information requested about acceptance criteria and a study that proves a device meets these criteria in the context of an AI/ML-enabled medical device, because this document pertains to a traditional medical device (a lubricant).
The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set sample size) are all highly relevant to the evaluation of AI/ML medical devices, which operate very differently from the product described in the provided text.
§ 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.