(59 days)
The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
This condom is a male contraceptive and prophylactic device which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. This condom is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600.
The provided document is a 510(k) Pre-market Notification for a latex condom, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its effectiveness against a set of acceptance criteria in the way medical diagnostic or AI-driven devices typically would.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader studies, and ground truth types is not explicitly detailed within this regulatory submission.
However, I can extract the information related to conformance with required specifications and physical testing which implies a form of acceptance criteria and performance evaluation.
Here's an attempt to answer your request based on the available information, noting the absence of detail for many of your points:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied) Reported Device Performance Conformance to ASTM D3492 standards "revealed results in conformance with required specifications" Conformance to ISO 4074 standards "revealed results in conformance with required specifications" Conformance to EN 600 standards "revealed results in conformance with required specifications" Biocompatibility: Not toxic (local or systemic) "The condom is not toxic (local or systemic)" Biocompatibility: Not sensitizing "not sensitizing" Biocompatibility: Not locally irritating "not locally irritating" Biocompatibility: Not otherwise harmful "not otherwise harmful" Colorfastness "revealed results in conformance with required specifications" Air inflation testing "revealed results in conformance with required specifications" Other in-process and final release testing (physical properties) "revealed results in conformance with required specifications" -
Sample sizes used for the test set and the data provenance: Not explicitly stated. The document mentions "All physical testing, air inflation testing, colorfastness testing, including other in-process and final release testing." The provenance would be from manufacturing batches of the device, likely from India where the manufacturer is located. It is an intrinsic part of the manufacturing quality control process, not a separate clinical "test set" in the sense of a diagnostic device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for condom performance in this context refers to adherence to international and national standards for physical properties and biocompatibility. This is assessed through laboratory testing, not expert interpretation of results.
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Adjudication method for the test set: Not applicable. Laboratory testing against predefined standards does not typically involve adjudication in the expert consensus sense.
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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 device is a physical product (condom), not an AI-driven diagnostic tool or imaging system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical device like a condom.
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The type of ground truth used:
- External Standards: ASTM D3492, ISO 4074, and EN 600 for physical properties.
- Biocompatibility Standards: Methods of ISO 10993 Biological Evaluation of Medical Devices and ODE Guidance Memorandum G95-1 (for 24 hours or less contact with skin/mucosal membrane).
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The sample size for the training set: Not applicable. There is no "training set" in the context of a physical product's regulatory submission for demonstrating substantial equivalence. All testing mentioned relates to quality control and final product verification against established standards.
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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.