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The Flexible Video-Choledo-Cysto-Ureteroscope 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-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.

This document is a 510(k) premarket notification for a new medical device, the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. Therefore, the "study" referred to is primarily a non-clinical performance evaluation comparing the proposed device to a predicate device, rather than a clinical trial or AI-specific validation study typically associated with AI/ML devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table between the proposed device (PL-2100) and its primary predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686, Model: PL-1000). The "acceptance criteria" are implied by the predicate device's characteristics, and the "reported device performance" are the proposed device's characteristics. The goal is to show they are "Same" or "Similar" in ways that don't raise new questions of safety or effectiveness.

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

The document explicitly states: "No Clinical Study is included in this submission." This means there isn't a "test set" in the sense of patient data used for algorithm validation. The evaluation is primarily based on non-clinical engineering and performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no clinical study or expert-adjudicated ground truth dataset was used for device efficacy or performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study or expert adjudication process for a test set was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is an endoscope system, not an AI/ML-assisted diagnostic device that would typically undergo an MRMC study to evaluate human reader improvement with AI assistance.

6. Standalone Algorithm Performance:

Not applicable. The device is a hardware system (endoscope and imaging processor), not a standalone algorithm.

7. Type of Ground Truth Used:

For the non-clinical performance and safety evaluations, the "ground truth" is established by international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993) and the specified performance characteristics of the predicate device. The proposed device's performance is measured against these established engineering and safety benchmarks.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The Flexible Video-Choledo-Cysto-Ureteroscope 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-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Flexible Video-Choledo-Cysto-Ureteroscope System is composed of sterile Flexible Video-Choledo-Cysto-Ureteroscope and an non-sterile Imaging Processor System (Including Light Source).The Flexible Video-Choledo-Cysto-Ureteroscope is composed of Control Section, Light-guiding Section, Connector Section, Insertion Tube and Distal End. The Control Section is pulled by the wire rope to control the bending direction of the Distal End.

The Light-guide section transmits the illumination light from the image processor to the Distal End. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal End contains a camera system and a lighting system for illumination and observation.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface.

Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends.

The product is equipped with tiny size digital imaging parts --photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Flexible Video-Choledo-Cysto-Ureteroscope System." As such, it does not contain the information requested regarding acceptance criteria, study details (sample sizes, expert involvement, ground truth methods), or the performance of an AI/algorithm.

The document primarily focuses on establishing substantial equivalence to a predicate device (Flexible Video-Uretero-Choledochoscope System, K142556) based on:

• Indications for Use: The current device has similar indications for endoscopic examination in the urinary tract and bile ducts.
• Technological Characteristics: Comparison of features like imaging technology (CMOS), illumination source (LED), distal end size, deflection, field of view, and imaging processor system capabilities.
• Non-clinical Performance Data: Mention of testing against ISO standards for function, performance, electrical safety (IEC 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993). Sterilization process and EO residual validations are also mentioned.

Crucially, Section 5.8 "Clinical Test Data" explicitly states: "No Clinical Study is included in this submission." This means there is no data presented here about human performance (with or without AI assistance), standalone algorithm performance, or a comparative effectiveness study.

Therefore, I cannot provide a response filling in the requested details about acceptance criteria or a study proving the device meets those criteria, as that information is not present in the provided text. The device approval here is based on substantial equivalence to a predicate, not on a clinical trial demonstrating performance against specific quantitative acceptance metrics.

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