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The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages.

These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology:

• Urogenital tract

• Nephroscopy

The Flexible Sensor-Ureterorenoscope BOA VISION EF (short name: BOA) and Flexible Sensor-Ureterorenoscopes COBRA VISION EF (short name: COBRA) are flexible video endoscopes used for visualizing body cavities and organs via natural and surgically created passages.

The Flexible Sensor-Ureterorenoscopes compromise a handle and a flexible shaft connected to the handle with an active controlled deflection section at the endoscope tip.

The video image of the Flexible Sensor-Ureterorenoscopes is produced by a CMOS imaging sensor located at the tip of the insertion shaft together with the objective lens. The imaging sensor with the electronics in the handle generates a signal that is transferred to the designated camera controller ENDOCAM Flex HD (cleared with K161204), which processes the signals to display them on a monitor (not part of this submission).

The Flexible Sensor-Ureterorenoscopes use integrated LED lights for illumination.

The Flexible Sensor-Ureterorenoscopes provide a working channel with 1.2 mm diameter and a working length of 680 mm length. A Luer sealing cap may be used to seal the provided Luer connectors if not used.

The Flexible Sensor-Ureterorenoscope COBRA VISION EF has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which support to move the clamped laser fiber sensitively by turning an adjustment ring for contacting the stone.

Parts of the Flexible Sensor-Ureterorenoscopes have direct patient contact. When used as intended, the duration of tissue contact is limited (up to 24 hours). The used raw material with direct or indirect patient consist of Stainless steel, optical glass, Polyurethane, Perfluoroalkoxy (PFA) and adhesives (epoxy).

I am sorry, but the provided text does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) premarket notification for Flexible Sensor-Ureterorenoscopes. It outlines the device's indications for use, comparison to a predicate device, and various performance tests conducted to demonstrate substantial equivalence, such as biocompatibility, cleaning and sterilization validation, electrical safety, photobiological safety, and some mechanical and optical performance.

However, it does not include:

• A table of acceptance criteria and reported device performance for metrics like accuracy, sensitivity, or specificity.
• Details about sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human readers with AI assistance.
• Specifics about standalone algorithm performance.
• The type of ground truth used (beyond general performance testing).
• Sample size for a training set or how its ground truth was established, as the device doesn't contain software and therefore wouldn't have a "training set" in the AI/ML context.

The document primarily focuses on demonstrating the new device's safety and effectiveness compared to a predicate device through adherence to various international and FDA standards, which are general engineering and medical device safety standards, not performance metrics for an AI/ML-based device.

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