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The KARL STORZ Flexible Video-Uretero-Renoscope System is Indicated for endoscopic examination In the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The system components are the Flexible Video-Uretero-Renoscope and the Image 1 SPIES Camera Control Unit (CCU). The Flexible Video-Uretero-Renoscope 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 is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 SPIES CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard HD display monitor. The modifications made to the Flexible Video-Uretero-Renoscope System (K131369) are the conversion to the Image 1 SPIES CCU (K135319), material changes for STERRAD compatibility, a reduction in the insertion portion from 700mm to 675mm, and revision of the reprocessing instructions.

This document is a 510(k) summary for the KARL STORZ Flexible Video-Uretero-Renoscope System. It describes modifications to a previously cleared device (K131369) and asserts substantial equivalence to that predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it describes general compliance with standards and successful testing.

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify a sample size for any test set (e.g., number of devices tested, number of simulated uses, etc.).
• The data provenance is non-clinical testing performed by the manufacturer, Karl Storz Endoscopy-America, Inc. There is no mention of country of origin of the data beyond implied internal testing by the applicant. The testing described is prospective in nature, as it's for a modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not applicable as the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above; no clinical test set was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document states "Clinical testing was not required."

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• This device is a physical medical instrument (Flexible Video-Uretero-Renoscope System) with an imaging sensor, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The testing described is for the device's physical and functional performance, optical characteristics, and safety.

7. The Type of Ground Truth Used:

• For the non-clinical performance and safety testing, the "ground truth" was established by compliance with recognized international standards (e.g., ISO 14971, ISO 8600, IEC 60601-1, IEC 60601-1-2, ISO 10993) and the validated functional specifications of the device.

8. The Sample Size for the Training Set:

• This device is a physical medical instrument, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable.

9. How the Ground Truth for the Training Set Was Established:

• As above, the concept of a "training set" is not applicable for this device.

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The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The crucial components of the system are the Flexible Video-Uretero-Renoscope and the Image 1 HD Camera Control Unit. The Flexible Video-Uretero-Renoscope 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 is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 HD CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard SD or HD monitor. The Karl Storz Flexible Video-Uretero-Renoscope System is a Class II device under 21 CFR 876.1500.

The provided text describes a 510(k) summary for the Karl Storz Flexible Video-Uretero-Renoscope System. This device is not an AI/ML medical device, therefore, the information requested in the prompt related to acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical performance and safety testing.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table; rather, it refers to successful testing against established standards. The performance is summarized qualitatively.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device for visualization, not an AI/ML device that uses data for a test set. The validation methods involved physical device testing, not data analysis sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of expert-established ground truth related to diagnostic performance or image interpretation, as the device is for direct visualization.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML diagnostic device with a test set requiring adjudication.

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
Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an endoscope system that is used with a human in the loop for live visualization and procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its physical and optical performance characteristics as measured against engineering specifications and international standards (e.g., ISO 8600, IEC 60601 series).

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

9. How the ground truth for the training set was established
Not applicable.

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