(85 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 colored pink, yellow, green or black. It is lubricated with silicone 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 text describes a 510(k) Notification for a Male Latex Condom and does not contain information about a medical device that utilizes AI, nor does it detail a study with the specific criteria requested (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).
The information in the document pertains to the regulatory submission for a physical medical device (a latex condom) and focuses on its substantial equivalence to a predicate device based on manufacturing standards and material properties, rather than performance metrics from a clinical study as would be relevant for an AI-powered device.
Therefore, I cannot fulfill the request to provide acceptance criteria and study details for an AI-powered device from the given text.
However, based on the information provided, I can construct a table of acceptance criteria and reported device performance related to the physical specifications and regulatory compliance of the latex condom as described in the 510(k) summary.
Acceptance Criteria and Reported Device Performance (Based on Latex Condom Specifications)
| Acceptance Criteria (from ASTM D3492/ISO 4074 compliance) | Reported Device Performance (from K023129 submission) |
|---|---|
| Nominal length | 180-mm |
| Nominal width | 52-mm |
| Nominal thickness | 0.06mm |
| Material | Natural latex sheath |
| Wall type | Straight-walled |
| Tip type | Reservoir tip |
| Lubrication | Silicone |
| Dressing material | Cornstarch |
| Color options | Pink, yellow, green or black |
| Compliance with ASTM D3492 | Conforms to standard |
| Compliance with ISO 4074 | Conforms to standard |
Regarding the specific questions about an AI device study:
- A table of acceptance criteria and the reported device performance: See the table above for the physical device specifications. There is no information for an AI device.
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device.
- Adjudication method for the test set: Not applicable. This is not an AI device.
- 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. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: For a physical condom, "ground truth" would be the measured physical properties and adherence to manufacturing standards (e.g., length, width, thickness, burst strength, freedom from holes, packaging integrity). The document states conformance to ASTM D3492 and ISO 4074.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI 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.