(327 days)
ONE® Oasis 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.
ONE® Personal Lubricant (water-based formulation) is a non-sterile, aqueous-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy, odorless, gel-like liquid. This device is not a contraceptive nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.
The provided text is a 510(k) summary for a personal lubricant (ONE® Oasis Personal Lubricant). It describes the device, its intended use, and various tests performed to demonstrate its safety and compatibility. However, this document does not contain acceptance criteria or a study that uses a test set to prove the device meets acceptance criteria.
The information presented is focused on demonstrating substantial equivalence to a predicate device and includes:
- Biocompatibility testing: This confirms the product is non-toxic, non-sensitizing, non-irritating to vaginal and penile tissue, and has no evidence of systemic toxicity or negligible skin irritation.
- Condom compatibility testing: This demonstrates compatibility with natural rubber latex, polyisoprene, and polyurethane condoms.
- Shelf-life testing: This indicates a one-year shelf life based on an accelerated aging study, with a real-time study ongoing for confirmation.
Therefore, I cannot fill out the requested table and answer the questions related to acceptance criteria, test sets, ground truth, experts, MRMC studies, or standalone performance because this information is not present in the provided text.
The document describes the tests performed (biocompatibility, condom compatibility, shelf-life) and their respective positive results, which are intended to show the device's safety and effectiveness for its intended use and compatibility with condoms. These tests serve as evidence supporting the 510(k) clearance, but they are not framed as a "study that proves the device meets acceptance criteria" in the way a clinical trial or a performance study with defined metrics and thresholds would be described for an AI/ML 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.