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The Monarch® Platform, Urology and its accessories are intended to access and visualize anatomical locations within the urinary tract and interior of adolescents and adults, aged 12 and up, for diagnostic and therapeutic procedures with transurethral access or transurethral access in conjunction with percutaneous access.

The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Monarch® Platform, Urology ("Proposed Device") is a capital equipment platform that enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. The ureteroscope and suction catheter move only under continuous and direct physician control, via the Monarch Controller.

The proposed device consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Software, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch Urology diagnostic and therapeutic procedures. The device as well as its instruments and accessories are used together during urological diaenostic and therapeutic procedures and are bundled in this 510(k) submission so they can be addressed during one review. The summary descriptions of each component are outlined below.

Monarch® Tower: The Monarch® Tower (Tower) contains the primary procedural display interface for the physician that is provided by a touchscreen monitor for physician viewing and computers running the Monarch software. The monitor has a touchscreen and allows for user input during setup and intra-operative use. The tower has integrated electromagnetic (EM) tracking and video signal processing components. In addition, the tower provides connectivity for the endoscope camera as well as the fluidics pump.

Monarch® Cart: The Monarch® Cart (Cart) contains a touchscreen, three robotic arms and electronic systems required to power and operate the robotic arms. The Cart touchscreens accepts user input and shows instructions for arm deployment and cart functions. The robotic arms possess multiple degrees of freedom. The cart transmits the physician directed movement to the Ureteroscope and other instruments during a procedure.

Monarch® Fluidics Pump: The Monarch® Fluidics Pump (Fluidics Pump) controls the irrigation and suction during a procedure. The Fluidics Pump is connected to the Monarch Tower via an umbilical cable allowing electrical and data communication. The Fluidics Pump provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures.

Monarch® Software: The Monarch® Software provides the user with the ability to safely drive the Monarch® Ureteroscope and Monarch® Mini-PCNL suction catheter around the kidney and within the calyces of interest as well as provides optional navigation guidance to the user to insert the needle to the target during Monarch® PCNL procedure. It receives user input from the Monarch® Controller, computes the appropriate robotic motion to coordinate the movement of the robotic arms and endoscopic devices loaded onto the Cart. It provides a graphical user interface where the endoscopic camera view is shown in real time and displays important system status information.

Monarch® Controller: The Monarch® Controller) is a handheld device that serves as the user interface that allows the physician to control the system during a procedure. An Umbilical cord connects the Controller to the Tower.

Monarch® Ureteroscope: The Monarch® Ureteroscope (Ureteroscope) is comprised of an endoscope that provides vision, illumination, and a working channel to the distal tip of the device. The Ureteroscope can be navigated by the user within the bladder, urinary tract, and kidney. It contains a working channel to accommodate compatible commercially available working channel instruments. The Ureteroscope can be articulated 2-directions (along a single plane) when manually driven or can be articulated 4-directions (along two planes) when mounted to the electromechanical arms under command by the physician using the endoscopic controller. The shaft of the ureteroscope can also be rolled 155° in either direction to reorient the camera and working channel. The Ureteroscope is packaged within the Monarch® Ureteroscopy Kit. The Monarch® Ureteroscopy Kit also includes Ureteroscope Valve, Ureteroscope Driver and Laser Driver (accessories for Ureteroscopy procedure).

Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO.

• Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope.
• Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes:
  • 8Fr dilator
  • 10Fr catheter
  • Percutaneous Sheath Dilator ●
• Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

The provided text describes performance data but does not specify quantifiable acceptance criteria for the Monarch® Platform, Urology device. Instead, it states that the device was tested against internal design specifications and applicable performance standards to demonstrate safety and effectiveness, and that "all intended user needs evaluated met their acceptance criteria." However, what those specific quantitative acceptance criteria were for different aspects (e.g., accuracy, reliability, image quality) and the reported performance against them are not detailed in the provided document.

Therefore, the following information is based on what can be extracted or inferred from the provided sections, recognizing the absence of explicit quantitative acceptance criteria and specific performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not provide a table of explicit acceptance criteria with specific quantitative targets and corresponding reported device performance values. The general statements are that all tests "Passed" or "met acceptance criteria."

Therefore, I cannot construct the requested table with specific numerical values for acceptance criteria and reported device performance.

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

The document mentions "live porcine model" for Design Validation and "Acute Animal Safety" studies.

• Sample Size for Test Set: Not explicitly stated as a numerical count for either the Design Validation or Acute Animal Safety studies. The phrasing "live porcine model" and "live animal model" are general.
• Data Provenance: The studies were conducted using "live porcine model" and "live animal model," indicating animal testing (pre-clinical). The location or country of origin is not specified, but it suggests a controlled laboratory setting. The studies are prospective in nature, as they involve active testing and data collection.

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

The document mentions "intended users" and "representative users" in the context of Human Factors and Usability evaluation and Design Validation. However, it does not specify the number of experts used to establish ground truth for any test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for any test set. The term "ground truth" itself is not explicitly used in the context of expert review in the provided text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The Monarch® Platform is described as a capital equipment platform with electromechanical articulation and control, and software for navigation, but there is no indication of an AI component designed to assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the Monarch® Platform as a system that requires "continuous and direct physician control" and where "Device movement is only at the command of the physician." The software provides "optional navigation guidance." This indicates that the device is designed for human-in-the-loop operation, and the description does not support the idea of a standalone (algorithm-only) performance study.

7. The Type of Ground Truth Used

Based on the descriptions:

• Design Validation and Acute Animal Safety: The "ground truth" for these studies would implicitly be established through direct observation, physiological measurements, and potentially post-mortem examination in the animal models, assessing safety and functionality in a simulated use environment. This is a form of direct-measurement or observation-based ground truth specific to animal model performance.
• Other tests (Reprocessing, Sterility, Biocompatibility, Electrical Safety, Software, Verification Testing, Human Factors): These rely on adherence to established standards and internal specifications, where "ground truth" is defined by the objective pass/fail criteria of technical tests rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

The document describes pre-market testing and validation for a medical device (Monarch® Platform, Urology). It does not mention a "training set" in the context of machine learning or AI, as the primary focus seems to be on the electromechanical system and software components rather than a learning algorithm that requires a training set.

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

As no "training set" for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text.

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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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