(140 days)
TROJAN® HER PLEASURE™ (Ribbed) ECSTASY® Latex Condom with Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN® HER PLEASURE™ (Ribbed) ECSTASY® Latex Condom with Lubricant is a male condom consisting of a sheath of natural rubber latex with a silicone-based lubricant, designed with ribs and a larger bulbous end than the predicate device. The condom has a nominal length of 200 mm and a maximum nominal flat-width of 52-54 mm. measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 73 mm. The condom is consistent with the specifications in ASTM D3492-08 for condoms having a shaped profile about the closed end.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance characteristics of the TROJAN® HER PLEASURE™ (Ribbed) ECSTASY® Latex Condom:
1. A table of acceptance criteria and the reported device performance
The document primarily references ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) for physical testing and presents consumer-use performance data (slip/breakage rates) for comparison to other marketed condoms. The implicit acceptance criterion for the consumer-use data is comparability to these existing products.
| Acceptance Criteria / Performance Metric | Reported Device Performance (TROJAN® HER PLEASURE™ (Ribbed) ECSTASY®) | Comparator Performance (Control Condoms) | Notes |
|---|---|---|---|
| Physical Testing | Met specifications of ASTM D3492-08 | N/A (Standard specification) | Three lots tested. The specific numerical thresholds for burst pressure, volume, etc., as per ASTM D3492-08, are not detailed in the provided text, only that the device "met specifications." |
| Consumer-Use Performance | The acceptance criterion for these metrics is implied to be "comparable to currently marketed latex condoms." | ||
| Slippage Rate | 1.99% | 1.09%, 0.99%, 0.00% | |
| Breakage Rate | 0.46% | 0.11%, 0.54%, 0.00% | |
| Total Failure Rate | 2.45% | 1.20%, 1.53%, 0.00% | Total Failure Rate = Slippage Rate + Breakage Rate. The document concludes these results "support that the slip and break rates...is comparable to currently marketed latex condoms." |
| Biocompatibility | Considered safe for consumer use | N/A | Studies included in vitro cytotoxicity extract, vaginal irritation, penile irritation, acute systemic toxicity, sensitization, and bacterial reverse mutation assay. |
| Shelf-life | Initial expiration date set at 36 months | N/A | Will be verified through real-time stability for five years. Guided by 21 CFR §801.435. |
2. Sample sized used for the test set and the data provenance
- Physical Testing: Three (3) lots of the device were tested.
- Consumer-Use Performance:
- Test Set Sample Size: Over 1250 couples participated in the study.
- 500+ couples used over 1300 TROJAN® ECSTASY® condoms (including the 510(k)-subject).
- 750+ couples used more than 2200 currently marketed TROJAN® latex condoms (control).
- Data Provenance: The study is described as a "branded consumer preference study." It is a prospective study conducted to gather real-world use data. The country of origin is not explicitly stated, but given the manufacturer's location (Princeton, NJ) and submission to the FDA, it is highly likely to be U.S.-based.
- Test Set Sample Size: Over 1250 couples participated in the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this device and its studies. The "ground truth" for condom performance studies relies on direct observation of user experience (slippage and breakage) and adherence to objective physical performance standards. There are no "experts" in the traditional sense establishing a ground truth as there would be for medical imaging or diagnostic devices.
4. Adjudication method for the test set
This is not applicable. The consumer-use study involved direct reporting of events (slippage/breakage) by the users themselves. Physical testing is based on objective laboratory measurements against a standard. No adjudication by experts is a part of this process.
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
This is not applicable. An MRMC study is relevant for diagnostic devices where human interpretation of medical images or data is involved, often with AI assistance. This submission concerns a physical medical device (condom), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.
7. The type of ground truth used
- Consumer-Use Performance: The ground truth for slip/breakage rates is based on direct observational data reported by couples during actual use.
- Physical Testing: The ground truth is established by adherence to the objective, quantitative specifications outlined in ASTM D3492-08.
8. The sample size for the training set
This is not applicable. Condom performance studies, as described, do not typically involve "training sets" in the context of machine learning or AI algorithm development. The "training" for such a device effectively comes from its design and manufacturing process, which are regulated by quality systems. The consumer-use study is a validation, not a training activity.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.