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Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.

Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope.

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

Medical Video Endoscope System is consist of a Single-use Video Ureterorenoscope and a Medical Video Processor. The proposed device 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 Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.

The Medical Video Processor is a reusable device. The Medical Video Processor is composed of a power circuit, an image processing circuit and software.

The provided text describes the Huger Medical Instrument Co., Ltd.'s "Medical Video Endoscope System" and its substantial equivalence to a predicate device (K172098). However, it does not contain acceptance criteria for specific device performance metrics or the details of a study proving the device meets said criteria in the format requested.

The document primarily focuses on:

• Indications for Use: What the device is intended for (endoscopic surgery within the urinary tract and kidney).
• Device Description: Components of the system (Single-use Video Ureterorenoscope and Medical Video Processor).
• Non-Clinical Test Conclusions: A list of standards and types of tests performed (biocompatibility, software, bench performance including optical and physical/functional, and use-life testing). These tests demonstrate compliance with relevant standards and similarity to the predicate device in certain aspects.
• Substantial Equivalence (SE) Comparison: A detailed comparison table between the proposed device and the predicate device, highlighting similarities and differences in various specifications (e.g., field of view, depth of field, dimensions, materials).
• SE Conclusion: A statement that the proposed device is as safe, effective, and performs as well as or better than the predicate.

Missing Information (from the provided text):

The input document does not detail specific acceptance criteria values (e.g., "resolution must be X lp/mm") and corresponding quantitative results from a study that explicitly demonstrates the device "meets the acceptance criteria." Instead, it states that tests were conducted according to standards and that performance is "similar to the predicate device" or "meets the requirements of ISO 8600-1, ISO 8600-4 and ISO 8600-7."

Therefore, I cannot populate the table or answer most of the specific questions about the study's methodology, sample sizes, expert involvement, or comparative effectiveness with human readers as this information is not present in the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not explicitly state acceptance criteria in a quantitative format for most parameters, and often refers to "similarity" to the predicate or "compliance with standards" without specific numerical targets, a comprehensive table cannot be precisely generated from the given information.

However, based on the comparative effectiveness section (Table 2 and subsequent analysis), here's an attempt to infer or describe reported performance relative to the predicate:

2. Sample size used for the test set and the data provenance:
The document does not specify sample sizes (number of devices, images, or data points) for any of the non-clinical tests or comparisons. Data provenance information (country of origin, retrospective/prospective) is also not provided.

3. 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 study appears to be non-clinical bench testing and comparisons to a predicate device, not involving expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set:
Not applicable, as there's no indication of a clinical study or expert adjudication process described.

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, the document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance effectiveness is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not explicitly stated or described. The document refers to "Software verification and validation testing," but does not detail a standalone algorithm performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" would be established by physical measurements, adherence to standards, and direct comparison of specifications and optical properties between the proposed and predicate devices, rather than clinical ground truth types.

8. The sample size for the training set:
Not applicable/not provided. This device description pertains to hardware and its performance, not an AI/ML component with a training set.

9. How the ground truth for the training set was established:
Not applicable/not provided, as there's no mention of a training set for an AI/ML component.

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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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