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

Flexible Video-Choledochoscope is a kind of medical 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. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light 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.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a Flexible Video-Choledochoscope, which asserts substantial equivalence to a predicate device based on technical and performance characteristics.

Specifically, the document mentions:

• No Clinical Study is included in this submission. (Section 5.9 Clinical Test Data)
• Non-clinical Performance Data: "The following performance tests were conducted to substantial equivalence: mechanical performance: duodenosoone compatibility testing and flexible surgical instrument compatibility testing and comparison performance testing." (Section 5.8 Non-clinical Performance Data)

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.

I am sorry, but the provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for a device to meet those criteria. The document is a 510(k) clearance letter from the FDA for a "Biliary Pancreaticobiliary Scope System."

Here's what I can tell you based on the provided text, and what is missing:

Information Present in the Document:

• Device Name: Biliary Pancreaticobiliary Scope System
• Intended Use/Indications for Use: The system is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system, including the hepatic ducts. It provides direct visualization, illumination, and guidance for accessory devices.
• Non-Clinical Tests Summary: The document lists various non-clinical tests performed, including:
  • Biocompatibility (Cytotoxicity, Intracutaneous reactivity, Sensitization, Acute systemic toxicity, Pyrogen)
  • Sterilization and shelf life testing (ISO 11135:2014, ISO 10993-7:2008, ASTM F1980-21, ISO 11607-1.2019, ASTM F 1886/F1886M-16, ASTM F88F88M-15, ASTM F 1929-15)
  • Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2)
  • Software Verification and Validation Testing (according to FDA guidance)
  • Bench performance testing:
    • Optical performance (ISO 8600 series)
    • Color performance (color reproduction), optical performance (resolution, depth of field, image intensity uniformity), SNR, dynamic range, frame frequency, and system delay test compared with the predicate device.
    • Mechanical testing (water resistance, deflection, working channel system leakage, articulation reliability, attachment to duodenoscope reliability, irrigation pump compatibility)
  • Animal testing (referring to FDA Guidance-General Considerations for Animal Studies Intended to Evaluate Medical Devices)
• Clinical Testing: "Not Applicable." This explicitly states that clinical testing was not performed for this submission.
• Predicate Device: SpyGlass DS Direct Visualization System (K142922)

Information NOT Present in the Document (and therefore cannot be provided by me):

1. A table of acceptance criteria and the reported device performance: While various tests are listed, the document does not provide specific quantitative acceptance criteria (e.g., "resolution must be X lp/mm") or the measured performance results of the device against these criteria. It only states that the device "complies with" certain standards or that tests were "performed."
2. Sample size used for the test set and the data provenance: This information is not provided for any of the tests, nor is there a "test set" in the context of clinical or AI performance. The animal test simply states it was conducted, but no details on size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no clinical or AI performance study with human expert review is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Irrelevant due to no clinical or AI performance study.
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, as 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, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the non-clinical tests described. For the animal study, the ground truth would be based on observations during the animal procedure, but no details are given.
8. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence through non-clinical performance, safety, and compatibility testing, rather than a detailed clinical effectiveness study with acceptance criteria and performance data. The phrase "Performance testing and compliance with voluntary standards demonstrate that the proposed Biliary Pancreaticobiliary Scope System is substantially equivalent to the predicate device" serves as the overall conclusion for meeting FDA's requirements for this 510(k) pathway.

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The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller.

The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions.

The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

This document is a 510(k) summary for the Dragonfly™ Pancreaticobiliary Scope, Digital Controller, and Instrument Channel Caps. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the new device's performance against specific acceptance criteria. This type of regulatory submission typically does not include the level of detail requested in your prompt regarding specific acceptance criteria, test set characteristics, expert involvement, or training data for AI/ML-based devices.

Based on the provided text, here's what can be extracted and what cannot:

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

The document lists performance tests conducted, implying that the device passed these tests. However, it does not explicitly state specific quantitative acceptance criteria for each test. Instead, it broadly states "All testing was performed on test units representative of finished devices. The device passed the following tests."

Here's a table based on the types of tests performed, as specific numerical acceptance criteria are not provided:

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests are generally laboratory-based device performance tests, not clinical studies involving patient 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)

This information is not provided in the document. The listed tests are engineering and performance validation tests for a physical medical device, not AI/ML algorithm performance studies that would require expert-established ground truth. Expert involvement in defining test methods or interpreting results would be part of the manufacturer's internal quality system, but is not detailed here.

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

This information is not provided. Given the nature of the tests (engineering and device performance), formal adjudication methods like 2+1 or 3+1, which are common in clinical trial or AI model validation, are not typically applicable or detailed in this type of submission.

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

The document does not mention or imply that an MRMC comparative effectiveness study was done. The device is an endoscope system, not an AI-assisted diagnostic tool. Therefore, the question about human reader improvement with AI assistance is not relevant to this submission.

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

The document does not describe any standalone algorithm performance testing, as the device is a medical imaging and intervention tool, not an AI/ML algorithm.

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

For the physical device performance tests listed (e.g., dimensional verification, image quality, electrical safety), the "ground truth" is typically defined by engineering specifications, relevant international standards (e.g., ISO, IEC), and internal design requirements. This is not explicitly defined as expert consensus, pathology, or outcomes data in the context of this submission.

8. The sample size for the training set

This information is not provided. There is no indication in the document that the device incorporates an AI/ML component requiring a training set.

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

This information is not provided, as there is no mention of a training set or AI/ML components for which ground truth would need to be established.

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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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AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

The Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a sterile single-use endoscope which is used with the video processor (Model: EOS-H-01. FDA cleared #K211169) produced by AnQing for providing endoscopic imaging within the bile duct for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version). The Flexible Choledochoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, an aspiration button, an aspiration connector, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning a Flexible Choledochoscope. This type of document is for a medical device that does not rely on complex algorithms or AI for its primary function. Therefore, the concepts of "AI algorithm," "acceptance criteria for an AI model," "training dataset," "test set," "ground truth establishment," "MRMC studies," and "standalone performance" as they relate to AI are not applicable to this submission.

The acceptance criteria and performance data provided in this document are entirely related to the physical and functional characteristics of the choledochoscope itself, not an AI component.

Here's an analysis of the document in relation to the questions asked, noting where the questions are not applicable due to the nature of the device:

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is a physical medical device (a choledochoscope), the "acceptance criteria" are related to its physical properties, safety standards, and functional performance compared to a predicate device.

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

The document presents a comparison table between the subject device (Flexible Choledochoscope, Models CS50H-20EU, CS50H-20US) and its predicate device (Olympus CHF TYPE V), showing "acceptance criteria" as functional and physical similarities and differences. The "reported device performance" is essentially that the subject device meets or is comparable to the predicate device in these aspects, and where there are differences, non-clinical tests were conducted to demonstrate equivalence without raising new safety/effectiveness concerns.

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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 Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.

The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Pancreaticobiliary Video System consists of:

Single-Use Video Pancreaticobiliary Scope:

• CDS11001
• CDS11002
• CDS11003
• CDS11004
• CDS11005
• CDS22001 ●
• CDS22002
• CDS22003
• CDS22004
• CDS22005

PB Digital Controller:

• BS-W-100

The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.

The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Insertion port
• Suction port
• Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope

The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.

CMOS and optical components are identical for all specifications of products.

• Working channel port
• Lever which can lock the control

The Single-Use Video Pancreaticobiliary Scope have different size as follows:

• Maximum insertion portion width
• Effective working length
• Minimum accessories channel width

The PB Digital Controller has the following physical and performance characteristics:

• Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
• Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
• Can connect to an external monitor
• Reusable device

The provided text describes a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd.'s Single-use Video Pancreaticobiliary Scope and PB Digital Controller. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study proving an AI device meets acceptance criteria.

The document discusses bench testing to demonstrate the performance of the proposed device against a predicate, but it does not involve an AI device or a study structured to prove an AI's performance against specific acceptance criteria, including human expert evaluation.

Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for an AI device, sample sizes for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The relevant sections of the document explicitly state:

• "No animal study is included in this submission."
• "No clinical study is included in this submission."

This indicates that clinical (human) performance data, which would be crucial for evaluating an AI device's effectiveness, was not part of this submission for market clearance. The "Performance Data" section (page 10-11) lists a series of bench tests for physical and electrical characteristics of the scope and controller, not for an AI algorithm.

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The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller.

The SpyGlass Discover Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic

Controller:

The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The SpyGlass Discover Digital System comprises two components: (1) a sterile, single-use endoscope, the SpyGlass Discover Digital Catheter (the "Catheter"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass Discover Digital Controller (the "Controller").

The SpyGlass Discover Digital Catheter comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The catheter cable connects the catheter handle to the Controller for transmitting illumination and video signals.

The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the catheter, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the catheter. The user interface of the Controller comprises a power button, a receptacle to connect the catheter connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.

It appears you've provided documentation for a 510(k) submission to the FDA for the SpyGlass Discover Digital System. This document is a "510(k) Summary" and a "Clearance Letter." These documents describe the device and its indications for use, but they do not contain any information about acceptance criteria or actual device performance study results.

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical efficacy or safety through new clinical studies. While substantial equivalence often relies on performance testing, the provided text does not describe the specific acceptance criteria for a study or the results of such a study in the format you requested.

Therefore, I cannot extract the information to fill out your table and answer your questions regarding acceptance criteria and performance study details from the provided text. The document states:

• "The proposed SpyGlass Discover Digital System shares the same intended use and fundamental scientific technology as the predicate SpyGlass DS Direct Visualization System (K183636)." This suggests that Boston Scientific is primarily relying on the established performance of the predicate device and engineering design changes, rather than a new de novo clinical performance study with specific acceptance criteria and results for this submission.
• "Most of the SpyGlass Discover Digital Catheter components are identical in dimensions and in mechanical performance to its predicate." This further supports the reliance on the predicate's performance.

To answer your questions, you would typically need a separate clinical study report or a more detailed technical file that outlines the validation testing, acceptance criteria, and specific performance outcomes of the device.

If you have a document that describes a specific performance study (e.g., a "clinical report," "verification and validation report," or "performance data" section), please provide that, and I would be happy to help.

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