(72 days)
The HAVE IT condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the SAFE™ Male Latex Condom in the way a modern AI device submission would. Instead, it focuses on the device being "substantially equivalent" to legally marketed predicate devices and complying with existing regulations for latex condoms.
However, based on the context of condom regulation, general implied performance criteria would be:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Material & Design | Substantially equivalent to predicate devices for contraception and STD prevention. | Determined to be substantially equivalent. |
| Shelf Life/Stability | Complies with 21 CFR 801.435 regarding expiration dating and shelf life. | Must comply retrospectively, data not provided in 510(k). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail a specific "test set" or sample size in the context of a study for this device. The approval is based on "substantial equivalence" to predicate devices and adherence to established regulations. Therefore, there's no explicitly mentioned test set for evaluating the device's performance that would typically be described for a software or AI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert-established ground truth in the way a diagnostic AI device would. The ground truth for condom effectiveness is based on historical performance of predicate devices and regulatory standards built on extensive public health data.
4. Adjudication Method for the Test Set:
Not applicable. There was no specific "test set" and thus no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is a pre-market notification for a physical medical device (latex condom), not an AI algorithm. Therefore, an MRMC study is not relevant and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the SAFE™ Male Latex Condom is based on:
- Established performance of predicate devices: The FDA determined that this condom is "substantially equivalent" to other legally marketed condoms, which have a track record of effectiveness for contraception and STD prevention.
- Regulatory standards and scientific understanding: The regulations like 21 CFR 884.5300 and 801.435 are built upon decades of scientific evidence and public health data regarding the efficacy and safety of latex condoms.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process.
§ 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.