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For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.

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The provided text K022287 is related to a 510(k) premarket notification for the 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters. This document is an FDA clearance letter, which means the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this type of document (a 510(k) clearance letter) typically does not include detailed study results, acceptance criteria, or performance data in the format of a clinical trial or performance study report. The FDA's substantial equivalence determination for 510(k) devices often relies on comparison to existing devices and verification of manufacturing and safety controls, rather than extensive new clinical efficacy studies.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the device's performance will not be found in this document.

The document only states the "Indications For Use" for the various types of Foley catheters offered (Two-Way, Three-Way, Radiopaque, Temperature Sensing).

If such detailed performance data and acceptance criteria exist, they would be in the original 510(k) submission itself, which is a much more extensive document not
publicly available in this format.

To answer your request based on the provided text, I must state that the information requested is not present.

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