(43 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, and nominal thickness 0.06mm. It is either lubricated with silicone or non-lubricated; with cornstarch as a dressing material, and Benzocaine (an over-the-counter drug generally recognized as safe and effective by the USFDA) placed inside the condom for desensitizing the male genitals. 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) submission for a male latex condom. It mostly focuses on the regulatory process, the device's description, and its intended use, rather than a detailed study proving the device meets specific acceptance criteria in the way a medical imaging AI device study would.
Therefore, for many of the requested points, the information is not available in the provided document. I will fill in what can be inferred and state when information is not present.
Acceptance Criteria and Device Performance
The core of the acceptance criteria for this device (a male latex condom) is compliance with established national and international voluntary standards. The document specifically mentions ASTM D3492 and ISO 4074. While it doesn't provide a table of performance against specific measurable criteria within these standards, the statement "The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex" implies that the device meets the criteria outlined in these standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Conformance to ASTM Latex Condom Standard D3492 | The design is in conformance with ASTM D3492. |
| Conformance to ISO 4074 (International Voluntary Standard) | The design is in conformance with ISO 4074 (stated as a general goal). |
| Nominal length 180-mm | Nominal length 180-mm |
| Nominal width 52-mm | Nominal width 52-mm |
| Nominal thickness 0.06mm | Nominal thickness 0.06mm |
| Use of Benzocaine as a male genital desensitizer | Benzocaine is placed inside the condom. |
| Lubrication with silicone or non-lubricated with cornstarch | Lubricated with silicone or non-lubricated with cornstarch. |
Note: The document states the device "is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." It then explicitly states "The design is in conformance with ASTM Latex Condom Standard D3492." The actual performance data (e.g., burst pressure, leakage, tensile strength tests specified by these standards) is not included in this summary but would have been part of the full 510(k) submission.
Study Details
- Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The evaluation is focused on adherence to standards rather than a clinical trial with a "test set" in the context of an AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a condom, "ground truth" is typically defined by adherence to manufacturing specifications and performance standards, not expert interpretation of diagnostic images.
- 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. 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 (expert consensus, pathology, outcomes data, etc.): For this type of device (male latex condom), the "ground truth" would be the device meeting the physical and material specifications outlined in the applicable standards (ASTM D3492, ISO 4074). This would involve laboratory testing for properties like burst strength, freedom from holes, dimensions, etc.
- 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.