Search Results

This instrument is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA MVM 7.5 French Ureteroscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Ureteroscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the Karl Storz Endoscopy - America, Inc. MVM 7.5 French Ureteroscope. This document does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device.

The content focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway means the manufacturer is asserting the new device is as safe and effective as a legally marketed device, and therefore does not require new widespread clinical trials or detailed performance studies with strict acceptance criteria as might be seen for novel devices or AI-powered diagnostics.

Here's why the requested information cannot be extracted from the provided text:

• No specific performance metrics are mentioned for the device itself. The device is a video endoscope, and the performance is implicitly handled by showing it's similar to previously approved models.
• The document does not describe a "study" in the traditional sense of a clinical trial or performance evaluation with a test set, ground truth, or expert readers. It's a regulatory submission demonstrating equivalence based on design, materials, and intended use.
• There is no AI/ML component. The device is a physical endoscope.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies because these details are not present in the provided 510(k) summary for this type of medical device.

Ask a specific question about this device