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This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.

The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.

• Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
  | Product name | Single Use
  Ureteroscope | Suction Access | Single Use
  Ureteroscope | Flexible Video |
  |----------------|----------------------------|----------------|----------------------------|----------------|
  | Model | PU400A | PU411A | PU3033H | PU3033AH |
  | Suction access | Yes | Yes | Yes | Yes |
  | Buttons | Yes | Yes | No | Yes |
• . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
• The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.

The provided text describes a submission to the FDA for a medical device (Single Use Suction Access Ureteroscope and Single Use Flexible Video Ureteroscope) and its comparison to a predicate device. However, it does not contain information related to software AI performance or studies specifically designed to establish AI acceptance criteria.

The document focuses on the safety and effectiveness of the physical ureteroscope devices, including aspects like:

• Biocompatibility
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation (for the device's operational software, not AI)
• Mechanical and optical performance
• Image quality (of the physical device's optics, not AI-enhanced image analysis)
• Photobiological safety
• Luer taper
• Sterilization and shelf life

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI component, as it is not present in the given text.

The closest relevant section is "Software Verification and Validation Testing," which states:
"Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023)."

This refers to the software controlling the device's basic functions, not an AI component for medical diagnosis or image interpretation. Without specific details on AI functionality, performance metrics, or clinical studies involving AI, the requested table and study details cannot be generated from this document.

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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 Pusen Single Use Flexible Video Cystem is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Video Cystoscope 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 System includes a Single Use Flexible Video Cystoscope and an HD Medical Video Endoscope Image Processor. The Pusen Single Use Flexible Video Cystoscope 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 has two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Cystoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Cystoscope is powered by the HD Medical Video Endoscope Image Processor PV300. 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 and display the real-time video on its LCD screen, which enables visual examination of the lower urinary tract (the urethra and the bladder).

The provided FDA 510(k) summary for the Pusen Single Use Flexible Video Cystoscope System does not describe specific acceptance criteria in quantitative terms nor does it detail a study that proves the device meets such criteria in the format requested. The document outlines general categories of performance data that were used to demonstrate substantial equivalence to a predicate device.

Here's an attempt to extract and present the information based on the provided text, acknowledging where specific details are missing:

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

The document does not explicitly state quantitative acceptance criteria for the performance tests, nor does it provide specific numerical results for the device performance beyond stating that tests were "passed" or "complies with." The table below summarizes the listed performance tests and the general outcome.

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 does not specify the sample sizes used for any of the described performance tests (e.g., how many cystoscopes were tested for mechanical performance, how many individuals for biocompatibility, etc.). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though the nature of these tests (bench, lab-based) inherently implies prospective testing within a controlled environment.

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)

The document does not mention the involvement of experts for establishing ground truth, as the performance data is primarily technical and bench-test based (e.g., biocompatibility passes, electrical safety compliance). No clinical studies or expert consensus for interpretation were conducted as part of this submission.

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

Not applicable. The reported data relates to bench testing, not clinical interpretation that would require an adjudication method.

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 such study was conducted or reported. The device is a "Single Use Flexible Video Cystoscope System," not an AI-assisted diagnostic tool.

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

Not applicable, as the device is a medical instrument (cystoscope system), not an algorithm or AI.

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

The "ground truth" for the performance tests described would be derived from:

• Compliance with international standards: For biocompatibility, electrical safety, EMC, photobiological safety, Luer taper, and sterilization validation (e.g., ISO 10993-1, IEC 60601 series, IEC 62471, ISO 80369-7, ISO 11135).
• Engineering specifications/measurements: For mechanical and optical performance (e.g., working length, channel diameter, angle of deflection, field of view, depth of field, flow rates, tensile strength, resolution, color reproduction, distortion).
• Accelerated aging and package integrity testing: For shelf life validation.

8. The sample size for the training set

Not applicable, as this is a medical device approval, not an AI/machine learning algorithm submission that requires a "training set."

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

Not applicable, as there is no "training set."

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This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

The Medical Video Endoscope Image Processor PV210 is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from digital endoscope and outputs signals to a medical monitor to display. PV210 has integrated software to control the operation of the device. PV210 is a reusable device and do not require sterilization before use, as there is no direct/in-direct patient contact material. It needs to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual. The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

This document is a 510(k) summary for the Pusen™ Eview™ Medical Video Endoscope Image Processor, Model PV210. Primarily, this device processes signals from an endoscope and converts them for display on a monitor.

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

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it indicates compliance with recognized safety and performance standards. The "device performance" reported is that the device "conforms to the requirements" of these standards and "met all requirements" of performance specifications.

Study Information:

1. Sample size used for the test set and the data provenance:
   The document mentions "bench testing" and "software verification and validation testing," which implies that hardware and software components of the device were tested. However, it does not specify any sample sizes for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for the testing conducted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The testing described appears to be engineering and software validation rather than clinical performance evaluation that would typically involve expert-established ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Since the testing described is technical compliance and performance verification, adjudication methods typically associated with clinical studies (like 2+1 or 3+1 for image interpretation) are not applicable and not mentioned.

4. 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:
   An MRMC comparative effectiveness study was not done and not mentioned. This device is an image processor, not an AI-powered diagnostic tool, and the submission primarily focuses on substantial equivalence to a predicate device based on technical specifications and safety. There is no mention of AI assistance or human reader improvement.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document describes "Software verification and validation testing" and "Bench testing of performance specifications." These would be considered standalone evaluations of the device's technical functionality, but not in the context of an "algorithm only" performance for diagnostic accuracy as implied by the question. The device processes signals; it doesn't perform diagnostic algorithms.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the technical and safety testing conducted, the "ground truth" would be the requirements of the specified electrical, EMC, and software standards, and the pre-defined performance specifications. There is no mention of clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:
   This information is not applicable and not provided. The device is an image processor, not a machine learning or AI-driven system that would require a "training set."

8. How the ground truth for the training set was established:
   This information is not applicable and not provided for the reasons stated above.

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This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The optical fiber transmits the light emitting from the LED light built in the handle to the coelom. The complementary metal-oxide-semiconductor CMOS imaging sensor in the distal tip of the insertion shaft receives the reflected light from the surface of mucosa and transforms the light into electric signal. The cable transfers the electric signal to the data processing center of the Eview, where the electric signal is processed. As a result the color imaging of the capillary network and mucosal morphology is displayed on the screen of the Eview.

The Medical Video Endoscope system is a digital flexible ureteroscope system that consists of the Eview (the video system, touch PC with data processing center) and the Uscope. The Uscope is provided sterile (sterilized by EO) and intended to be single-use.

The Uscope, as provided sterile, contains an insertion portion, handpiece and the cable. The handpiece is made with polymer plastic, Contacted with users. The insertion portion, as the part connected with patients, includes the sheath which is braided tube made of SUS 304 stainless steel and PEBAX, the controllable portion and the distal tip. The controllable tip is made of SUS 304 stainless steel, covered with silicone rubber. The distal tip is made with ABS. There is a working channel that terminates at the distal tip, which is indirect patient-contacting component, made of Fluorinated ethylene propylene.

The Eview, the video system contains touch PC with data processing center and provide energy to Uscope. The Eview can be powered by the main line or lithium battery.

The provided text describes a 510(k) premarket notification for a "Medical Video Endoscope System," which is a device for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. The document discusses device characteristics, intended use, and non-clinical performance data to establish substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria for a study showing device performance in the context of an AI/ML algorithm or a human-in-the-loop scenario. The performance data presented is related to safety, electrical safety, EMC, biocompatibility, sterilization, and general functional characteristics of the endoscope itself, rather than performance in terms of diagnostic accuracy or treatment efficacy compared to a predefined benchmark.

Therefore, many of the requested information points, particularly those related to AI/ML specific studies, human reader performance, expert consensus, and ground truth establishment for diagnostic performance, are not available in the provided text.

Here's a summary of what can be extracted from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests performed and states that "All evaluation acceptance criteria were met." However, it does not provide the specific quantitative acceptance criteria or detailed results for device performance in a diagnostic or clinical efficacy context. The tests reported are primarily related to safety and functional specifications.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance data (electrical, EMC, biocompatibility, sterilization, and functional testing), not a diagnostic or clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as this is not a diagnostic performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe a study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope system, not an AI algorithm.

7. The type of ground truth used: For the non-clinical performance evaluations, the "ground truth" or reference was against established engineering standards (e.g., IEC, ISO) and regulatory guidance for safety and performance.

8. The sample size for the training set: Not applicable, as this is not a machine learning device.

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

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This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The optical fiber transmits the light emitting from the LED light built in the handle to the coelom. The complementary metal-oxide-semiconductor CMOS imaging sensor in the distal tip of the insertion shaft receives the reflected light from the surface of mucosa and transforms the light into electric signal. The wire transfers the electric signal to the data processing center of the Eview , where the electric signal is processed. As a result the color imaging of the capillary network and mucosal morphology is displayed on the screen of the Eview.

The Medical Video Endoscope system is a digital flexible ureteroscope system that consists of the Eview( the video system, touch PC with data processing center) and the Uscope. The Uscope is provided sterile( sterilized by EO) and intended to be single-use.

The Uscope contains an insertion portion, handpiece, cable and water tube.

The Eview, the video system contains touch PC with data processing center and provide energy to Uscope. The Eview can be powered by the main line or lithium battery.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The document (a 510(k) summary) describes a "Medical Video Endoscope System" and its performance testing. However, it does not provide a detailed table of acceptance criteria with specific numerical targets and reported performance values. Instead, it generally states that evaluation acceptance criteria were met. It also does not describe a study focused on proving that humans improve with AI assistance. The device appears to be a standalone system that performs image acquisition and display for endoscopic procedures with a single-use ureteroscope.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not include a specific table with numerical acceptance criteria and corresponding reported performance. It mentions several standards and states that "All evaluation acceptance criteria were met" for specific tests.

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

The document does not explicitly state the sample size for any of the performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests appear to be laboratory/bench testing of the device itself rather than clinical studies with patient data.

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

This information is not provided in the document. The performance tests described (electrical safety, EMC, biocompatibility, sterilization, and basic functional characteristics) do not typically involve human experts establishing a "ground truth" in the way a diagnostic algorithm might. These tests rely on established engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. The tests described are primarily objective engineering and biological evaluations, not human-interpreted diagnostic assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to this document. The device is a "Medical Video Endoscope System," which is a viewing and surgical tool, not an AI diagnostic aid designed to improve human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, in a sense. The described "Non-Clinical Performance Data" are for the device's standalone operation and functionality (e.g., image quality, illumination, safety standards). There is no mention of an algorithm or AI component in the traditional sense; the "processing center" mentioned handles the video signal. The tests verify the device's ability to perform its core function: acquiring and displaying video from an endoscope.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Compliance with recognized international standards (IEC 60601 series, ISO 10993, ISO 11607, ISO 11135, ISO 8600).
• Functional specifications of the device (e.g., image quality, illumination, articulation, leak, flow rate).

This is not "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance studies. It's engineering and safety compliance.

8. Sample Size for the Training Set

Not applicable. This device is an endoscope system, not an AI or machine learning model that requires a training set.

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

Not applicable. As noted above, there is no AI training set for this device.

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