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SpeediCath Compact Eve is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The catheter is for female patients only.

The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The provided document is a 510(k) premarket notification letter and summary for the SpeediCath Compact Eve urinary catheter. This document does not contain information related to software or AI/ML device performance, acceptance criteria, or studies involving human readers or ground truth establishment in the context of AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document describes a physical medical device (catheter) and its testing for substantial equivalence to a predicate device, focusing on material, design, and regulatory compliance through physical and biological evaluations, not AI/ML performance.

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