(81 days)
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, nominal thickness 0.06mm and is colored. It is lubricated with silicone containing flavoring, and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided document is a 510(k) summary for a male latex condom, which is a medical device. However, it does not contain information about a study that proves the device meets acceptance criteria in the way that would typically be presented for an AI/software as a medical device (SaMD).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (LS Rubber Latex Condom; K020633) by showing that the new condom has the same intended use and technological characteristics and conforms to established voluntary standards (ASTM D3492 and ISO 4074). The acceptance criteria for medical devices like condoms are usually based on these established voluntary standards, which specify physical properties and performance requirements.
Therefore, I cannot directly answer your request in the format you provided for an AI/SaMD study. I will extract the relevant information regarding the device's conformance to standards, which serves as its "acceptance criteria" in this context, and explain why the other requested fields are not applicable.
Acceptance Criteria and Device Performance for UNIDUS Male Latex Condom
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Voluntary Standards) | Reported Device Performance |
|---|---|
| ASTM D3492 | Conforms to ASTM D3492 |
| ISO 4074 | Conforms to ISO 4074 |
| (General Performance Requirements) | Same intended use as predicate device |
| (Technological Characteristics) | Same technological characteristics as predicate device |
| (Material) | Made of natural latex condom |
| (Dimensions) | Nominal length 180-mm, nominal width 52-mm, nominal 0.06mm |
| (Features) | Straight-walled with a reservoir tip; colored; lubricated with silicone containing flavoring; cornstarch as dressing material |
Explanation Regarding Other Requested Information:
The other requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission for a physical medical device like a condom. These fields are typically relevant for AI/Software as a Medical Device (SaMD) where performance is evaluated based on algorithm output against a ground truth established by experts or other definitive methods, often using large datasets of patient cases.
For this condom, "device performance" is assessed by physical and mechanical testing as per the referenced standards, not by an AI algorithm's diagnostic accuracy. The 510(k) process for such devices relies on demonstrating substantial equivalence and compliance with recognized consensus standards, rather than a clinical study comparing AI performance.
The submission states: "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex." This statement indicates that the device has undergone testing (e.g., burst tests, sterility tests, leakage tests) as specified by these standards, and the results met the requirements laid out in those standards. The 510(k) summary doesn't detail these specific test results but asserts compliance.
§ 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.