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The Karex Large and Extra Large condom is used for contraceptive and for . prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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This document is an FDA 510(k) clearance letter for "Large and Extra Large Condoms" manufactured by Karex Industries Sdn. Bhd. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical imaging or AI-based diagnostic devices.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means that the FDA reviewed documentation demonstrating that the new device is as safe and effective as a legally marketed device. For condoms, this typically involves manufacturing quality control and performance testing against established standards (e.g., ISO or ASTM standards) for burst strength, freedom from holes, dimensions, etc., rather than clinical studies with human subjects in the same way an AI diagnostic would be evaluated.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as this type of information is not present in the provided document because it is a clearance letter for a medical device that gained approval via substantial equivalency, not a clinical study report for an AI/diagnostic device.

If you have a document describing a clinical study or performance evaluation for an AI-based device, I can analyze that.

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