(105 days)
TROJAN® MAGNUM® Condom with WARMING™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN® MAGNUM® Condom with WARMING™ Lubricant is a male condom consisting of a sheath of natural rubber latex with a lubricated coating consisting of a glycol-type base to create a perception of warming. The condom is a taper-walled, non-textured, nipple-end condom as described in K 895640. The 510(k)-subject condom's physical specifications are substantially equivalent to the predicate device, the lubricant has been modified.
The provided text describes a 510(k) submission for the "TROJAN® MAGNUM® Condom with WARMING™ Lubricant." This is a medical device submission seeking clearance for a new product, not a study evaluating an AI algorithm's performance or a diagnostic device. Therefore, many of the requested fields related to AI, ground truth, experts, and comparative effectiveness studies are not applicable.
Below is an analysis of the available information based on the provided text, focusing on the device itself and its acceptance criteria as a traditional medical device (condom).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Reference Standard) | Reported Device Performance (TROJAN® MAGNUM® Condom with WARMING™ Lubricant) |
|---|---|---|
| Safety | Biocompatibility (cytotoxicity, irritation, acute systemic toxicity, sensitization, bacterial reverse mutation, mouse lymphoma assay) | Considered safe for consumer use under normal and reasonably foreseeable misuse conditions. |
| Physical Properties | ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) | Met the specifications of ASTM D 3492-08. |
| Shelf-life / Stability | 21 CFR §801.435 (evaluation of physical testing data) | Initial expiration date set at 36 months, to be verified through real-time stability up to five (5) years. Chemical compatibility between latex and lubricant established. |
| Intended Use | Contraception and prophylactic purposes (prevent pregnancy and STIs) | Remains the same as the predicate device. |
| Technological Characteristics | No significant changes in intended use, method of operations, materials, or design compared to predicate. Similar base lubricant formulation to secondary predicates, consistent with Special Controls of 21 CFR §884.5300. | Substantially equivalent to predicate MAGNUM condom in design and material. Glycol-based lubricant (different from predicate's silicone-based) but similar to secondary predicates (K073016, K000748). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Biocompatibility Studies: Not explicitly stated how many condoms or batches were used for the in vitro and in vivo biocompatibility tests.
- Sample Size for Physical Testing Data: "Three (3) lots of condoms with the WARMING™ lubricant were tested."
- Sample Size for Shelf-life: Not explicitly stated beyond "results of physical testing data."
- Data Provenance: The studies were performed on the 510(k)-subject device, indicating prospective testing by the manufacturer (Church & Dwight Co., Inc.). Country of origin of data is not specified but implied to be related to the manufacturer's testing facilities or contract labs. The submission is to the US FDA, so standards relevant to the US market were followed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device clearance, not an AI algorithm study requiring human expert ground truth for classification or diagnosis. The "ground truth" for condom performance is established by adherence to recognized national and international standards (e.g., ASTM D 3492-08) and regulatory requirements related to safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device clearance, not an AI algorithm study requiring adjudication of expert opinions. Performance is assessed against predefined quantitative and qualitative standards.
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 a medical device clearance for a condom, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (condom), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Regulatory Standards: Adherence to specific parts of the Code of Federal Regulations (e.g., 21 CFR §884.5300, 21 CFR §801.435).
- Consensus Standards: Meeting the specifications of industry-recognized standards like ASTM D 3492-08 for physical properties of male condoms.
- Biocompatibility Testing: Results from established in vitro and in vivo tests for toxicity, irritation, and sensitization.
- Predicate Device Performance: The primary ground truth for substantial equivalence is demonstrating that the new device performs "as well, or better, than the predicate MAGNUM condom" and "does not incorporate any significant changes in intended use, method of operations, materials, or design that could affect the safety and effectiveness."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device clearance, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #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.