(82 days)
Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is lubricated by a water based lubricant system. Typical (Average) Product Characteristics are as follows: • Straight walled, reservoir end • Nominal length (mm): 190mm+/-10mm • Nominal width (mm): 52 mm +/- 2mm • Nominal thickness (mm) .04 -0.01 Kimono MicroThin with Aqua Lube: .049mm +/- 0.01 Reality Ultra Lubricated: .065mm +/- 0.01mm
The provided text describes a 510(k) submission for new latex condoms and the FDA's clearance of the device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone study with detailed performance metrics and ground truth establishment, as would be typical for a novel AI/medical imaging device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this document because the device is a physical product (condom) and not a diagnostic AI system.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards and Specifications) | Reported Device Performance (Summary) |
|---|---|
| ASTM D3492 (National Standard for Latex Condoms) | Conforms to required standards, including ASTM D3492. |
| ISO 4074 (International Standard for Latex Condoms) | Conforms to required standards, including ISO 4074. |
| Company specifications | Conforms to Company specifications. |
| Physical testing | Revealed results in conformance with required standards and Company specifications. |
| Air inflation testing | Revealed results in conformance with required standards and Company specifications. |
| Other in-process and final release testing | Revealed results in conformance with required standards and Company specifications. |
2. Sample sized used for the test set and the data provenance
Not explicitly stated for the testing confirming conformance to standards. The document outlines a 510(k) submission for substantial equivalence based on adherence to standards, not a specific clinical trial with a defined test set sample size for a diagnostic AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) is not relevant for the physical testing of condoms against established standards.
4. Adjudication method for the test set
Not applicable.
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 physical product, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical product.
7. The type of ground truth used
The "ground truth" in this context is adherence to established national and international standards (ASTM D3492 and ISO 4074) and the manufacturer's own specifications for physical properties and performance (e.g., air inflation). This does not involve expert consensus on clinical cases or pathology as would be used for diagnostic devices.
8. The sample size for the training set
Not applicable. This is a physical product, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.