(59 days)
The Trojan XOXO Intense Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The Trojan™ XOXO™ Intense Ribbed Natural Rubber Latex Male Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Intense Ribbed condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a bulbous reservoir end shape and relies on ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) and ISO 4074:2002 Natural Rubber Latex Condoms - Requirements and test methods. The condom has ribs on the shaft and bulb. The Trojan™ XOXO™ Intense Ribbed condom has a nominal length of 185 ± 10 mm, a nominal thickness 0.09 ± .01mm, nominal flat-width of 54 ± 2 mm measured 30 mm from the open end and 65±2 mm bulb flat width. The Trojan™ XOXO™ Intense Ribbed condom is individually packaged into a foil container. Multiple individually foiled condoms may be packaged in a carton.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Biocompatibility: Cytotoxicity ISO Elution Method | Adherence to ISO 10993-5 (2009) | Passed |
| Biocompatibility: Acute Systemic Toxicity | Adherence to ISO 10993-11 (2006) | Passed |
| Biocompatibility: Primary Rabbit Skin Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Rabbit Vaginal Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Rabbit Penile Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Guinea Pig Maximum Sensitization | Adherence to ISO 10993-10 (2010) | Passed |
| Physical Testing | Met specifications of ASTM D3492-08 and ISO 4074 | Met specifications for all three tested lots |
| Shelf Life (Accelerated Stability Study) | Provide a 3-year (36 month) shelf-life | Found to have a 3-year (36 month) shelf-life |
| Shelf Life (Real-time Stability Study) | Verify 5-year (60 month) expiration dating (ongoing) | Will be verified according to 21 CFR 801.435 (ongoing) |
2. Sample size used for the test set and the data provenance
- Biocompatibility Testing: The specific sample sizes for each animal study (rabbit skin, vaginal, penile irritation, guinea pig sensitization) are not explicitly stated in the provided document, but implied by the ISO standards. The tests are prospective as they are performed on the new device according to established protocols.
- Physical Testing: "Three (3) lots" of the Trojan™ XOXO™ Intense Ribbed condom were tested. The data provenance is internal to the manufacturer's testing process. The document does not specify the country of origin of the data, but the testing conforms to international (ISO) and US (ASTM) standards.
- Shelf-Life Testing: The accelerated stability study was conducted on a sample of the product. The real-time stability study is ongoing. The specific sample sizes are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (condom) and the assessment relies on standardized physical and biological performance tests, not on expert clinical interpretation of images or data. The "ground truth" is defined by the passing criteria of the specified international and national standards (ISO and ASTM).
4. Adjudication method for the test set
Not applicable. The tests are objective and based on measurable parameters defined by the ISO and ASTM standards. There is no subjective interpretation requiring adjudication.
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 is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The ground truth for the device's performance is established by regulatory and industry standards. Specifically:
- Biocompatibility: ISO 10993 series standards.
- Physical Testing: ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) and ISO 4074: Natural Rubber Latex Condoms Requirements and Test Methods.
- Shelf-Life: 21 CFR 801.435.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set for this 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.