(160 days)
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).
A condom is a sheath which completely covers the penis with a closely fitting membrane.
The provided document, a 510(k) summary for the Royale® Brand Latex Condoms, explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies on adherence to voluntary standards and results from physical and in-process testing.
Therefore, many of the requested details, such as sample size for test sets, expert involvement, and ground truth establishment, are not applicable or cannot be extracted from this specific document as they pertain to clinical studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|
| ASTM-D-3492-96 requirements | Conformed to required specifications |
| ISO 4074, Part 1 requirements | Conformed to required specifications |
| ISO 4074, Part 6 requirements | Conformed to required specifications |
| May 1, 1995 FDA Biocompatibility Guidance | Conformed to required specifications |
| FDA Modified C. Matrix of ISO-10893 requirements | Conformed to required specifications |
| Air inflation testing requirements | Conformed to required specifications |
| Color fastness testing requirements | Conformed to required specifications |
| Other in-process testing requirements | Conformed to required specifications |
| Final release testing requirements | Conformed to required specifications |
| Shelf-life of 5 years | Supported by real-time testing data |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." All testing mentioned (physical, air inflation, color fastness, in-process, final release, and shelf-life) appears to be non-clinical, likely performed in a lab setting. The document does not specify sample sizes for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical studies were performed that would involve experts establishing ground truth for a test set.
4. Adjudication method for the test set:
- Not Applicable. No clinical studies were performed.
5. 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 device is a condom, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device is a condom, not an algorithm.
7. The type of ground truth used:
- Not Applicable for clinical ground truth. For the non-clinical tests, the "ground truth" was adherence to the specifications outlined in the referenced voluntary standards (ASTM, ISO, FDA guidances).
8. The sample size for the training set:
- Not Applicable. No machine learning or AI algorithm was involved.
9. How the ground truth for the training set was established:
- Not Applicable. No machine learning or AI algorithm was involved.
§ 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.