(529 days)
The Thai Nippon Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.
The provided text is a 510(k) summary for a male latex condom. It does not describe a study involving an algorithm or AI. Therefore, it is not possible to extract information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of AI or algorithm performance, nor can I provide details related to sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm.
The document discusses the substantial equivalence of their male latex condom to a predicate device, focusing on its physical characteristics and adherence to established industry standards for condoms (ASTM D3492:2008 and ISO 4074:2002).
However, I can extract the acceptance criteria (standards) that the physical device is designed to meet as per the document's reference to industry standards:
| Acceptance Criteria (Standard) | Reported Device Performance (Conformance) |
|---|---|
| ASTM D3492:2008 | Conforms |
| ISO 4074:2002 | Conforms |
Further information regarding this specific device:
- Sample size used for the test set and the data provenance: Not applicable to an AI or algorithm study in this context. The document implicitly refers to testing done to conform to the ASTM and ISO standards, but does not provide specific sample sizes or data provenance for these physical tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical product and not an AI or algorithm.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical condom, "ground truth" would be established by physical testing against the parameters defined in the ASTM and ISO standards (e.g., burst pressure, leakage, dimensions).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (male latex condom) and does not contain information relevant to AI or algorithm performance studies.
§ 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.