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The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural rubber latex male condom

This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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Natural Rubber Latex Male Condoms [Parallel Sided, Smooth, Lubricated or Non-lubricated]
a) Parallel Sided Smooth, 53mm Condoms
b) Parallel Sided Smooth, 53mm Condoms - Ultra Thin
c) Parallel Sided Smooth, 53mm Condoms - Super Thin
d) Parallel Sided Smooth, 56mm Condoms
e) Parallel Sided Smooth, 56mm Condoms - Ultra Thin
The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural Rubber Latex Male Condoms [Parallel Sided, Smooth, Lubricated or Non-lubricated]

This document is a 510(k) premarket notification decision letter from the FDA regarding Natural Rubber Latex Male Condoms manufactured by Karex Industries Sdn. Bhd. It is not a study proving a device meets acceptance criteria.

The document states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device is considered as safe and effective as a device already on the market, but it does not provide details on specific performance acceptance criteria or the studies conducted by the manufacturer to demonstrate those criteria were met for this particular condom.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Information on experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Details of a multireader multicase (MRMC) comparative effectiveness study.
• Evidence of a standalone algorithm performance study (as this is a physical medical device, not an AI algorithm).
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training data was established.

This document is an FDA approval letter, not a scientific study report. To get the requested information, you would need to access the technical submission documents provided by Karex Industries Sdn. Bhd. to the FDA, which are not included here.

Ask a specific question about this device