(333 days)
The TROJAN SUPRA® Lubricate Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth of 58 mm.
This document describes a 510(k) premarket notification for the TROJAN SUPRA® Lubricated Polyurethane Male Condom. The acceptance criteria and the study that proves the device meets those criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (TROJAN SUPRA® Polyurethane Condom) | Reference (Control Latex Condom) |
|---|---|---|---|
| Clinical Breakage Rate | Not significantly different from a standard latex condom control. | 0.6% | 1.3% |
| Clinically Significant Slippage Rate | Not significantly different from a standard latex condom control. | 1.1% | 0.5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Users/Cases): 206 couples.
- Data Provenance: Prospective, conducted in France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not explicitly provided in the document. The study involved "an In-Use Study" following an FDA guidance, and the outcomes were "clinical breakage rate" and "clinically significant slippage." It's customary for such clinical studies to involve medical professionals in assessing and recording these events, but the specific number and qualifications of experts are not detailed.
4. Adjudication Method for the Test Set
This information is not explicitly provided. Clinical studies often have adjudication committees for adverse events or endpoint assessment, but the document does not specify if one was used or the method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, an MRMC comparative effectiveness study was not conducted as this is a medical device (condom) and not an imaging-based diagnostic or AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical medical device (condom) and does not involve AI algorithms.
7. The Type of Ground Truth Used
The ground truth used was clinical observation and user reporting of objective outcomes, specifically:
- Clinical Breakage Rate: Direct observation/reporting of condom breakage during intercourse.
- Clinically Significant Slippage Rate: Direct observation/reporting of condom slippage during intercourse.
8. The Sample Size for the Training Set
No training set information is applicable or provided as this is a physical medical device, not an AI-based system.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of medical 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.