(387 days)
The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Titan Condoms are made of a natural latex sheath which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and a cylinder shape. Titan condoms are available in a range of sizes, with different length and width combinations. Surface textures include smooth, dotted, and ribbed. Titan Condoms are provided prelubricated with a silicone-based lubricant.
The provided text describes the acceptance criteria and a clinical study conducted for Titan Condoms, but it does not pertain to an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how training ground truth was established) are not applicable.
Below is the information specifically related to the acceptance criteria and the study as presented in the document for the physical device, Titan Condoms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Failure Rate 64 mm condom: 0% clinical failure rate69 mm condom: 3.1% clinical failure rate | |
| Biocompatibility | All tested subject devices were biocompatible. |
| Compliance with ISO 4074:2015 | All Titan Condom versions met all requirements. |
| Shelf-life | 5 years |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of condoms or participants for the clinical study. It mentions that "Each couple was to use three condoms."
- Data Provenance: Prospective clinical study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as this is a clinical study for a physical device, not an AI/ML device requiring expert ground truth for image or data interpretation. The ground truth (clinical failure) was observed directly during use.
4. Adjudication Method for the Test Set
Not applicable, as this is a clinical study for a physical device, not an AI/ML device requiring adjudication for result interpretation. The clinical endpoints were clinical condom slippage and breakage during use, participant's satisfaction, and genitourinary adverse events, reported via an online individual condom use case report form.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is a clinical study for a physical device, not an AI/ML device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this is a clinical study for a physical device, not an AI/ML algorithm.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on observed clinical outcomes: clinical condom slippage, breakage during use, participant satisfaction, and genitourinary adverse events, as reported by the users themselves.
8. Sample Size for the Training Set
Not applicable, as this is a clinical study for a physical device. There is no AI/ML model to train.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
§ 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.