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The Double Springers Nonoxynol 9 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 letter from the FDA to Medtech Products Limited regarding the substantial equivalence of their "Double Springers Nonoxynol 9 Lubricated Condom." This document is an FDA clearance letter and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the regulatory requirements for marketing. However, it does not describe the specific performance characteristics or the studies conducted to demonstrate those characteristics.

Therefore, I cannot provide the requested table and study details based on the given input.

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The Double Springers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

The provided text is a 510(k) summary for a natural rubber latex condom. It does not contain any information about a study with acceptance criteria and device performance data for an AI/ML powered device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, or training set information.

The document discusses the device's proprietary name ("Double Springers"), common name ("Latex Condom"), classification, and intended use for contraception and prophylactic purposes. It also mentions that the condom design conforms with ASTM Latex Condom Standard D 3492 and is a patented design (US Patent No: 5,836,308) with a special design to enhance acceptability.

The FDA's letter (pages 2-3 of the provided text) confirms the substantial equivalence of the "Double Springers" condom to legally marketed predicate devices, allowing it to proceed to market. It also provides guidance on labeling requirements for latex condoms regarding expiration dating.

In summary, this document is for a traditional medical device (latex condom) and does not involve AI/ML technology or studies related to its performance against acceptance criteria in an AI/ML context.

Ask a specific question about this device