(72 days)
Lubricating Liquid is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
PharmaPac Personal Lubricant is a water-based personal lubricant formulated to be a non-greasy, non-sticky, non-staining clear gel-like liquid. The water-soluble formula allows this product to be rinsed off with water.
The provided text is a 510(k) summary for the PharmaPac Personal Lubricant. It documents the submission for FDA clearance of a medical device, in this case, a personal lubricant. The content of this document does not contain the specific type of performance data and study details requested in the prompt, as it is a summary for a device that is substantially equivalent to a predicate device, and thus relies on the predicate's established performance rather than extensive new clinical studies.
Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.
The "Performance Data" section specifically states:
"Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards."
This indicates a stability study was performed, which is a chemical/physical performance test, not a study involving human subjects or expert review for diagnostic accuracy. This type of device (personal lubricant) does not typically require the kinds of studies (e.g., MRMC, standalone algorithm performance, expert consensus on images) that would involve the criteria you've outlined, as it's not an AI/imaging diagnostic device.
§ 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.