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Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.

The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.

The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.

The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models: CH-M50, CH-M52, CH-M40, CH-M32. The four models are the same except for the difference in the characteristics of the insertion tube, including diameter of the insertion tube, maximum insertion portion width and minimum insertion channel width.

The image processor is a reusable monitor.

The single-use choledochoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the choledochoscope and outputs video signals to a display.

The provided text describes the regulatory clearance of a medical device, the "Choledochoscope System," and highlights the tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not include the detailed information needed to answer many of the questions regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics related to AI or image analysis beyond general optical performance.

Specifically, the document states: "No clinical study is included in this submission" which is critical. This means the device's performance was primarily demonstrated through bench testing and compliance with standards, not through clinical trials or comparative effectiveness studies with human readers.

Therefore, for many of the requested points, the answer will be that the information is "Not available in the provided text" or "Not applicable as no clinical or AI-based performance study was conducted."

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions several performance tests and compliance with standards, but does not provide a table with specific acceptance criteria (e.g., minimum resolution, specific SNR values) and reported performance values for each. It generally states "Comply with" or "evaluated in accordance with."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable for human-data based test sets, as "No clinical study is included in this submission." For bench tests (e.g., optical, mechanical), the sample sizes are not specified in the document.
• Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company is based in Shenzhen, Guangdong, China. The testing appears to be primarily bench-top and engineering performance testing rather than human clinical data.
• Retrospective/Prospective: Not applicable, as no clinical studies were conducted using human data.

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)

• Number of experts: Not applicable. No clinical expert-driven ground truth was established, as no clinical study was conducted.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable. No clinical test set requiring expert adjudication was used.

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

• MRMC study: No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
• Effect size: Not applicable, as no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone performance: Not applicable. This device is an endoscope system (hardware and image processor), not an AI algorithm analyzing medical images. Its performance is related to its ability to capture and display images, not interpret them. The document refers to "Software Verification and Validation Testing" but treats the software as a "moderate" level of concern, indicating it's mainly for control and image processing, not diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of ground truth: For the engineering and performance tests (optical, mechanical, electrical, biocompatibility), the "ground truth" would be established physical measurements, engineering standards, chemical analyses, and standardized test methodologies. There is no biological/clinical "ground truth" in the form of expert consensus or pathology within this submission.

8. The sample size for the training set

• Sample size (Training Set): Not applicable. This submission is for a medical device (endoscope system), not an AI/ML model for which a training set would be described in this context. The software mentioned is for device operation and image display, not for learning from data.

9. How the ground truth for the training set was established

• Ground truth (Training Set): Not applicable, as this device does not involve a machine learning training set with biological or clinical ground truth.

In summary, the provided document focuses on demonstrating the substantial equivalence of the Choledochoscope System to a predicate device through adherence to established regulatory standards for medical device safety and performance (biocompatibility, sterilization, electrical safety, mechanical, and optical bench tests), rather than clinical efficacy or AI-driven performance.

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The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.

This system is intended for use in a hospital environment or medical office environment.

The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor.

This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.

• The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S, and PC200-R.
• The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter.
• The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.

This document is a 510(k) premarket notification for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." It seeks to establish substantial equivalence to a predicate device for an expanded indication (examination of bile ducts) from a previously cleared device (Pusen Single Use Flexible Video Cystoscope System K222602) which only covered the lower urinary tract.

The information provided does not contain acceptance criteria for device performance measured against the indicated use for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System," nor does it describe a study to prove its performance in meeting such criteria. Instead, it relies on non-clinical performance data (bench testing) and substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document presents a comparison of technological characteristics between the subject device, a predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686), and a reference device (Pusen Single Use Flexible Video Cystoscope System, K222602). This comparison (found on pages 5 and 6) lists specifications such as field of view, depth of field, working length, etc., but these are not presented as acceptance criteria for performance related to clinical outcomes or diagnostic accuracy.

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

This information is not provided. The document states, "No animal study or clinical study is included in this submission." This means there was no "test set" of patient data in the context of a clinical performance study. The "non-clinical performance data" mentioned refers to bench testing, for which sample sizes of tested units are not specified.

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

This information is not applicable/provided. Since no clinical or animal studies were conducted, there was no need for experts to establish ground truth based on patient or animal data.

4. Adjudication Method

This information is not applicable/provided. No clinical studies with expert adjudication were performed.

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

This information is not applicable/provided. No such study was performed, as explicitly stated by "No animal study or clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance can be reported.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/provided. The device described is an endoscope system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

This information is not applicable/provided for clinical performance. As stated, no clinical studies were performed. The "ground truth" for the non-clinical performance data would be based on engineering specifications and measurements (e.g., measuring angles of deflection, illumination intensity, image resolution in a lab setting).

8. Sample Size for the Training Set

This information is not applicable/provided. Since no AI or machine learning component is described for clinical decision-making, there is no "training set" in that context.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/provided. As above, there is no training set for an AI algorithm.

Summary of what the document does provide regarding performance:

The document relies on the following points to support the substantial equivalence:

• Non-Clinical Performance Data: "The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System and reference Pusen Single Use Flexible Video Cystoscope System (K222602) share the same fundamental technology and physical characteristics except for the Direction of view and the Maximum insertion portion width, verification reports on these two performances are provided." This indicates that specific bench tests were performed to verify these two differences. The document asserts that "The other performance data described in the cleared Pusen Single Use Flexible Video Cystoscope System, K222602, is also applicable to the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." This implies that prior bench testing for the K222602 device is considered sufficient for this new expanded indication, with only the differences verified.
• Substantial Equivalence Argument: The core of the submission is that the device is substantially equivalent to existing legally marketed devices, primarily the predicate device (K211686), which already has indications for both urinary tract and bile duct examination. The subject device is a modification of a previously cleared device (K222602), with the only change being an expanded "Indications for Use" to include bile ducts, matching the predicate. "No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated."
• Conclusion: "Performance testing and compliance with voluntary standards, demonstrate that the subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use."

In essence, the device's "performance" for its intended use, particularly the newly added choledochoscope indication, is justified by its similarity in design and technology to a predicate device that already holds that indication, combined with non-clinical (bench) testing to confirm that minor physical differences do not raise new questions of safety or effectiveness. No clinical studies directly demonstrating performance for the bile duct indication were submitted or required for this 510(k) clearance based on substantial equivalence.

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The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source).

The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.

Flexible Video-Choledochoscope System is composed of sterile Flexible Video-Choledochoscope and a non-sterile Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is composed of Operation section, Light-guide Section, Insertion a Distal tip and bending section. The Operation Section is pulled by the wire rope to control the bending direction of the Distal tip.

The Light-guide section transmits the illumination light from the image processor to the Distal tip. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal tip 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-Choledochoscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human 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 its monitor output for doctor observation and diagnosis.

The provided FDA 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it details the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

Therefore, I cannot provide the requested information.

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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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The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.

The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

The provided text describes the ACMI® DUR-Digital Ureteroscope and Choledochoscope System. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or quantitative performance metrics typically found in a clinical study or even a rigorous design verification and validation report for a complex medical device.

The information primarily focuses on demonstrating substantial equivalence to predicate devices for 510(k) clearance, rather than a standalone performance study with defined acceptance criteria and statistical proof.

Here's an analysis based on the provided text, highlighting what is and is not available:

Acceptance Criteria and Device Performance (Based on Provided Text)

The document states that the new device met performance requirements by demonstrating comparable performance to predicate devices. It does not define explicit, quantitative acceptance criteria in this summary.

Study Details and Missing Information:

Here's a breakdown of the requested information, indicating what is present and what is absent from the summary:

1. A table of acceptance criteria and the reported device performance

   • Availability: Partially available (implied criteria, general statement of performance). No specific quantitative criteria are provided.
   • Details: The "acceptance criteria" are implied to be "performance characteristics comparable to predicate devices." The "reported device performance" is a general statement that these characteristics were met or exhibited.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Availability: Not available.
   • Details: The document refers to "design verification" and "testing" but does not specify the sample size of devices tested or the data provenance. It's likely these were internal engineering tests rather than a clinical study.

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)

   • Availability: Not available.
   • Details: No information is provided about experts, ground truth establishment, or any form of expert review for testing. This type of submission focuses on technical equivalence rather than clinical performance evaluated by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Availability: Not available.
   • Details: No adjudication method is mentioned, as there's no reported expert-based evaluation.

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

   • Availability: Not available.
   • Details: No MRMC study was mentioned. This device is an endoscope system (a direct visualization tool), not an AI-powered diagnostic or assistive tool, so such a study would not be applicable or expected for this type of 510(k) submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Availability: Not applicable/Not available.
   • Details: This device is a manual medical imaging instrument (endoscope) used by a medical professional, not an algorithm, so a standalone algorithm performance study is irrelevant. The comparison focused on the technical performance of the device itself (e.g., image quality, physical dimensions) against predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Availability: Not available.
   • Details: Since the "testing" focused on comparing physical and visualization characteristics against predicate devices, the "ground truth" would likely be the established performance specifications or measured characteristics of those predicate devices, rather than clinical ground truth (like pathology or outcomes) for this type of submission. The summary does not elaborate on how this was established.

8. The sample size for the training set

   • Availability: Not applicable/Not available.
   • Details: This device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense.

9. How the ground truth for the training set was established

   • Availability: Not applicable/Not available.
   • Details: As there is no training set, this question is not relevant.

Summary of the Study:

The "study" described is a design verification and validation process conducted internally by the manufacturer (ACMI Corporation). Its purpose was to demonstrate substantial equivalence to already legally marketed predicate devices, the ACMI® DUR®-8E (for flexible endoscope technology, physical characteristics, and indications for use) and the ACMI® Invisio™ ICN System (for basic video imaging technology).

The core of the study involved:

• Comparing the physical performance characteristics of the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) against the predicate DUR®-8E.
• Comparing the digital visualization characteristics of the DUR®-D against the predicate Invisio™ ICN.

The conclusion was that the new device met its performance requirements and exhibited comparable performance characteristics to both predicate devices, thus presenting "no new questions of safety or efficacy." This type of demonstration is standard for a Traditional 510(k) submission, where the focus is on showing similarity to existing products rather than proving novel clinical effectiveness through large-scale trials.

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