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The KARL STORZ Flexible Video-Uretero- Choledochoscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Uretero-Choledochoscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

The Flexible Video-Uretero-Choledochoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The system components are the Flexible Video- Uretero-Choledochoscope and the Image 1 SPIES Camera Control Unit (CCU). The Flexible Video-Uretero- Choledochoscope uses an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination. The video image is produced by a complementary metal-oxide-semiconductor (CMOS) imaging sensor located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image 1 SPIES CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard HD display monitor.

This change is to expand the indications for the currently cleared secondary predicate Flexible Video-Uretero- Renoscope System (K141250) to allow it to also be marketed as a Choledochoscope used for examination of the bile duct and to allow the ability to percutaneously access the abdominal cavity for examination of the kidney. No changes were made to the device design as part of this update. Only the model number and applicable labeling were updated.

The provided text is a summary of a 510(k) premarket notification for a medical device, the Karl Storz Flexible Video-Uretero-Choledochoscope System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML devices.

This document pertains to a traditional medical device (an endoscope) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing performance against quantitative acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested sections about AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this document.

However, I can provide information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance data for the secondary predicate device (which is stated to be exactly the same as the current device in terms of technology and physical characteristics). It references compliance with standards rather than specific quantitative acceptance criteria or reported performance values.

2. Sample size used for the test set and the data provenance:
Not applicable/not provided. This is a traditional device submission focused on substantial equivalence, not an AI/ML study with a test set of data. The performance data refers to physical and electrical testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/not provided. Ground truth establishment with experts is not relevant for the type of device testing described (physical and electrical safety/performance).

4. Adjudication method for the test set:
Not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is not an AI/ML CAD device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an AI/ML CAD device.

7. The type of ground truth used:
For the non-clinical performance data (e.g., electrical safety, biocompatibility), the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601-1, ISO 10993, ISO 8600). The device's performance was compared against these standard requirements.

8. The sample size for the training set:
Not applicable/not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable/not provided. This is not an AI/ML device.

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