(234 days)
The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.
This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.
The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).
The condoms will be offered in the following Colors and Flavors:
- Yellow Banana
- Red Strawberry
- Green Mint
The provided document is a 510(k) Pre-Market Notification for a male latex condom (Trust Dams). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with detailed acceptance criteria and expert-read studies.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving it meets those criteria. Specifically:
- No acceptance criteria table or reported device performance is present because this is a physical medical device (condom), not an AI algorithm. The performance is assessed against established standards for latex condoms.
- No sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details are provided, as these are concepts relevant to AI/algorithm validation, not to the pre-market notification for a physical medical device like a condom.
- No training set details are relevant here.
The document indicates that the device (Trust Dams) is made from natural rubber latex condoms that conform to established national and international voluntary standards, specifically ASTM D3492:2008 Male Latex Condom Standard. The predicate device is "Sheer Glyde Dams (K990067)", and the condoms from which the oral dams are made were previously cleared by the USFDA (K070830).
The "technological characteristics" section states: "This oral dam has the same technological characteristics as the listed predicate device identified above. The latex condoms (sheaths) from which the dams are made conform with the ASTM D3492:2008 Male Latex Condom Standard." This conformity to an established industry standard is the primary basis for demonstrating substantial equivalence for this type of device.
In summary, the provided text does not contain information about an AI or algorithmic device study. It details the 510(k) submission for a physical medical device (latex dam) and bases its substantial equivalence on adherence to existing condom standards.
§ 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.