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The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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The provided text is a 510(k) clearance letter from the FDA for a male natural rubber latex condom. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. While it mentions regulatory compliance and substantial equivalence to a predicate device, it does not describe performance metrics or study designs typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific details outlined as they are not present in this document.

However, I can extract the information that is available:

Device Name: Male Natural Rubber Latex Condom
Indications For Use: Contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Regulatory Class: II
Product Code: 85 HIS
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom

The document primarily focuses on:

• Confirming the device's substantial equivalence to a legally marketed predicate device.
• Outlining general controls provisions and potential additional controls for Class II devices.
• Emphasizing compliance with labeling regulations, specifically regarding expiration dating for latex condoms (21 CFR §801.435).

To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) submission detailing the performance evaluation of an AI-powered device.

Ask a specific question about this device