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The Medical Video Endoscope is 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 image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

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 Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope 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 Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

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

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

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

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

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.

The provided FDA 510(k) clearance letter and summary describe a medical device (FLEX XC ureteroscope), not an AI or software-based medical device. Therefore, the information requested about acceptance criteria and studies that apply to AI/Software as a Medical Device (SaMD) are not present in this document.

The clearance is based on the substantial equivalence of the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) to a previously cleared predicate device (K141250 KARL STORZ Flexible Video-Uretero-Renoscope).

Here's an analysis of the provided information concerning the device's performance, but it does not include any of the AI/SaMD specific criteria you requested as the device is a physical endoscope.

Device: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Product Code: FGB
Regulatory Class: Class II

Acceptance Criteria and Reported Device Performance (Non-AI/SaMD)

Since this is a physical medical device (endoscope), the "acceptance criteria" primarily relate to its physical and functional specifications, and its compliance with relevant performance and safety standards.

Note on Differences: The subject device (FLEX XC) shows an improved deflection range (285° up/down vs. 270°) and a potentially wider field of view range (80-110° vs. 80-95°) compared to the predicate. The submission argues these differences do not raise new questions of safety and effectiveness, supported by non-clinical bench testing.

Study Details (Based on provided document)

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

Therefore, the following information, which is typically relevant for AI/SaMD clinical validation studies, is not applicable or not provided in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/SaMD performance was used. The reported "performance" comes from bench testing of the physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/SaMD performance was not established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device is its compliance with recognized performance standards and its physical and functional characteristics being comparable (or superior, without raising new concerns) to a cleared predicate.
7. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion: The provided FDA 510(k) clearance documentation for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) pertains to a traditional physical medical device, not a software-as-a-medical-device (SaMD) or AI-enabled device. The clearance is based on a demonstration of substantial equivalence to a predicate device through non-clinical bench testing, not through clinical studies involving human readers or AI algorithm performance analysis. Therefore, the specific criteria and study details related to AI/SaMD validation are absent from this document.

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The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract.

Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices, the intended medical indication will be defined by the connected visualization devices.

The Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope. It contains a miniature CMOS camera, light-emitting diodes (LED) illumination module at the tip and an EEPROM in the handle to store use time. The tip of the U-Scope has a bending portion with 270° ± 15° bidirectional bend angle in the bending section. The U-Scope connects to the I through a separate electrical connector for sending image data and receiving LED power. The U-Scope has an inner working channel no less than 1.20mm for the infusion fluid and instrument passage with two access ports. The insertion tube distal tip OD is available in two size configurations: Flexible Ureteroscope (2.8/1.2) and Flexible Ureteroscope (2.5/1.2). Apart from the size, the endoscopes share a similar design and working length of the ureteroscope is 670 mm. The Luer Port working lumen ID is 1.35mm and irrigation lumen ID is 1.3mm that is used for irrigation connection and accessory device access.

The reusable Images System (Camera-Controlled Unit) contains most electronics, including a power on/off button, touch screen, video processor, LCD, power management electronics and microcontrollers. The system includes the necessary hardware, software, and firmware to drive the endoscope CMOS camera and light-emitting diodes (LED), adjust live view images, capture images, save images to an external source, capture videos, save videos to an external source, manage saved image and files, and manage saved video files. The reusable Images System (Camera-Controlled Unit) has connectors for attaching and detaching the endoscope, external monitor, external memory, and DC power supply. The LCD has a touchscreen function for user interaction with the GUI to control the CCU functions. The display unit has a VESA mount incorporated into the rear of the enclosure for attachment to a cart or any existing customer mounting bracket that adheres to the same standard mounting pattern.

Both the reusable Images System (Camera-Controlled Unit) and the single-use Flexible Ureteroscope together complete the "Ureteroscope System" enabling a Flexible Ureteroscopy procedure to take place.

The provided FDA 510(k) clearance letter and summary describe a new flexible ureteroscope system. However, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets the acceptance criteria for AI/Software performance.

The document primarily focuses on the physical device (Flexible Ureteroscope) and its Camera-Controlled Unit. The "Software Verification Test was performed to verify the software functions against its intended use" is mentioned, but no detailed performance metrics, acceptance criteria, or study results are provided for any AI or algorithmic component.

Given the input, I cannot answer the questions regarding AI/Software acceptance criteria and performance study details. The information provided is for a traditional medical device (endoscope and camera system) and its non-clinical testing for substantial equivalence to a predicate device, which includes:

• Electrical Safety and Electromagnetic Compatibility: Tested according to IEC 60601-1, EN 60601-1-2, IEC 60601-2-18.
• Photobiological Safety: Assessed according to IEC 62471:2006.
• Mechanical and Optical Performance: Includes bending, working channel, flow rate, tensile and torsional strength, field of view, direction of view, resolution, noise, dynamic range, geometric distortion, and image intensity uniformity (with reference to ISO 8600 series standards).
• Software Verification Test: Performed to verify software functions against intended use. (This is the only mention of software, and it's a verification test, not a clinical performance study with AI metrics)
• Biocompatibility: Assessed according to ISO 10993 standards.
• Sterilization and Shelf Life: Validation according to ISO 11135:2014, environmental conditioning, simulated shipping, package integrity, and device performance testing.

Therefore, I cannot populate the table or answer the specific questions about AI acceptance criteria and performance studies because the provided text does not contain that information. The device described here does not appear to be an AI/ML-driven device based on the provided clearance letter.

To provide the requested information, the input document would need to include details about:

• A specific AI algorithm's function (e.g., automated detection of stones, tissue classification).
• Quantitative performance metrics (e.g., sensitivity, specificity, AUC) for that AI algorithm.
• The study design used to evaluate these metrics (e.g., standalone performance study, MRMC study).
• Details about the dataset (size, provenance, ground truth establishment, expert qualifications, adjudication).
• Specific acceptance criteria tied to the AI's performance.

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The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible Ureteroscope is intended to be used with Vathin Digital Video Monitor. During diagnosis and treatment, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.

The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. It is for use in professional Healthcare Facility Environment.

The provided FDA 510(k) clearance letter and its associated summary for the "Single-use Flexible Ureteroscope" does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the way one might expect for an AI-enabled device or a diagnostic accuracy study. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Therefore, the requested information cannot be fully extracted from the provided text. I will provide the acceptance criteria as implied by the non-clinical tests conducted to prove substantial equivalence, and note where specific information is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each bench test, nor does it provide specific numerical performance results. Instead, it states that the device "complies with" or "met its design specifications" or "has been validated according to" relevant standards.

Missing Information Details:

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The studies were non-clinical bench tests and biocompatibility tests, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the studies were non-clinical bench tests and material safety tests, not studies requiring expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench tests.
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 describes a medical instrument, not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by the specified performance limits or standards outlined in the applicable international standards (e.g., ISO, IEC, ASTM). For biocompatibility, it's the lack of adverse biological reactions.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the provided FDA document details the non-clinical testing performed to demonstrate the safety and effectiveness of a physical medical device (a single-use flexible ureteroscope) for substantial equivalence to a predicate device. It does not contain information related to diagnostic accuracy studies, AI performance, or clinical trials with human readers or patient data.

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The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The F88 URE-SD Flexible Ureteroscope, Standard Deflection and the F88 URE-RD Flexible Ureteroscope, Reverse Deflection (both also collectively referred to as the "F88 URE-SD/RD Flexible Ureteroscope") is a handheld flexible ureteroscope with a flexible insertion portion length of 670 mm and a maximum outer diameter of 3.05 mm. The device includes a working channel of 1.2 mm diameter for the insertion of various compatible flexible instruments and irrigation systems. The distal tip is equipped with a CMOS imaging sensor and an LED light source for live videos. The control body has a deflection lever to deflect the distal tip up to at least 270° in the up or down directions for navigation and access to targeted areas. The push buttons can be programmed to perform functions such as white balance, brightness, picture, record, zoom and to provide access to the setup menu.

The standard deflection (SD) and reverse deflection (RD) models are functionally identical, with one primary difference: the direction of the distal tip deflection in response to the deflection lever's movement. When the deflection lever of the standard model moves upward, the distal tip deflects upward. In the reverse model, when the deflection lever moves upward, the distal tip deflects downward. The model is selected depending on the handling preference of the user.

The F88 URE-SD/RD Flexible Ureteroscope is a reusable device.

The F88 URE-SD/RD Flexible Ureteroscope is compatible for use with the F88 Flexible Camera Control Unit (FCCU) and several accessories, listed below:

• Single Luer Stopcock
• Vent Cap with Sterilization Card
• Manual Leak Tester
• Luer Port Cleaning Brush
• Cleaning Brush
• URE Working Channel Cleaning Brush

The F88 Flexible Camera Control Unit (FCCU) or F88 flexible camera console is a device that processes and produces live video images during endoscopic procedures. It is used together with the F88 URE-SD/RD Flexible Ureteroscope and compatible surgical display monitors to form the F88 Flexible Camera System.

The provided FDA 510(k) clearance letter for the F88 URE-SD/RD Flexible Ureteroscope does not contain information about specific acceptance criteria related to accuracy metrics (like sensitivity, specificity, or AUC) or the results of a study designed to demonstrate the device meets such criteria for diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Karl Storz Flexible Video-Uretero-Renoscope, K141250) based on:

1. Identical Indications for Use: Both devices are indicated for endoscopic examination in the urinary tract, including the kidney, for diagnostic and therapeutic procedures.
2. Similar Technological Characteristics: The differences between the devices are described as minor and not raising new questions of safety or effectiveness.
3. Performance Testing to Address Safety and Effectiveness: This testing primarily covers non-clinical aspects essential for medical devices, such as biocompatibility, reprocessing validation, electrical safety, EMC, and software validation.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this document. This is common for 510(k) submissions for devices like endoscopes, where the primary concern is the device's physical and functional equivalence and safety, rather than a quantifiable diagnostic accuracy claim that would necessitate extensive clinical performance studies.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Device Performance (as inferable from the document):

Since the device is a flexible ureteroscope, the "acceptance criteria" discussed are largely related to functional performance, safety, and equivalence to a predicate device rather than diagnostic accuracy metrics. The document states that the device "performs as intended" and "has the same or better performance than the predicate device."

Detailed Study Information (Based on provided text):

1. Sample size used for the test set and the data provenance:

   • Not Applicable/Not Provided: The document does not describe a "test set" in the context of diagnostic accuracy data (e.g., medical images or patient cases). The performance testing conducted was primarily for engineering, safety, and functional validation (e.g., biocompatibility samples, reprocessed devices, electrical/EMC test units, software code).
   • Data Provenance: Not applicable for the types of tests described.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable/Not Provided: No "ground truth" (e.g., disease presence/absence determined by an expert) for diagnostic performance was established or discussed. The device is an imaging tool, not an AI diagnostic algorithm making determinations. For human factors testing related to reprocessing, it's plausible experts were involved, but details are not provided.

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

   • Not Applicable/Not Provided: There was no diagnostic "test set" requiring adjudication of ground truth.

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:

   • No: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." MRMC studies are typically for evaluating the impact of AI on human diagnostic performance. Since this device is an endoscope and not an AI diagnostic tool, such a study would not apply in this context.

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

   • No: This is a physical medical device (an endoscope) with an accompanying camera control unit. It is not an algorithm that performs standalone diagnostic tasks. The closest equivalent would be the "Software Verification and Validation Testing" for the F88 Flexible Camera Control Unit (FCCU), but this only validates the software's functionality, not its diagnostic accuracy in a standalone capacity.

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

   • Not Applicable/Not Provided: For a ureteroscope seeking 510(k) clearance based on substantial equivalence, the "ground truth" is typically the established safety and effectiveness of the predicate device and the adherence of the new device to relevant performance standards and engineering specifications. No diagnostic "ground truth" data was used for a clinical performance evaluation.

7. The sample size for the training set:

   • Not Applicable/Not Provided: This device is not an AI algorithm that requires a "training set" of data.

8. How the ground truth for the training set was established:

   • Not Applicable/Not Provided: No training set was used.

Summary of what the document does describe:

The study proving the device meets its "acceptance criteria" (which are more focused on safety, functional performance, and technological equivalence) consists of a comprehensive suite of non-clinical tests:

• Biocompatibility Testing: According to ISO 10993-1 and FDA guidance, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity.
• Reprocessing Validation: Cleaning, sterilization, and human factors testing.
• Electrical Safety and EMC Testing: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: For the FCCU, following FDA guidance for basic software, including various stages of testing.
• Cybersecurity Testing: Vulnerability assessment and penetration testing following FDA guidance.
• Additional Performance Testing:
  • For Ureteroscopes: Design Verification, Simulated Transportation Validation, and Comparative testing with the predicate device.
  • For FCCU: Design Verification, EMC, Control Unit Feature Verification, System Reliability Testing, Video Performance and Timing, RF Interference, and Simulated Transportation Validation.

The overall approach relies on demonstrating that the new device is fundamentally similar to a previously cleared device, and that any minor differences do not adversely impact safety or effectiveness, as confirmed by robust non-clinical engineering and safety testing.

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The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.

The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures.

The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapters transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media.

The provided FDA 510(k) Clearance Letter for the LumiRex Ureteroscope does not detail a clinical study with acceptance criteria and device performance in the way typically expected for an AI/software as a medical device (SaMD) clearance. The document focuses on hardware aspects of the ureteroscope, such as sterilization, biocompatibility, electrical safety, and basic bench testing (e.g., field of view, depth of field, image quality).

Specifically, there is no mention of an AI component, an algorithm, or any study involving human readers or ground truth for diagnostic accuracy. The "Software" section primarily refers to verification and validation of the device's operating software (e.g., for image processing, LED control) according to IEC 62304, not an AI or diagnostic algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device (in the context of an AI/diagnostic algorithm) meets acceptance criteria, an MRMC study, or the establishment of ground truth for a diagnostic task. The document provided does not contain this information.

Based on the provided text, the LumiRex Ureteroscope is a physical medical device (endoscope) and not an AI/SaMD product that would typically involve the type of diagnostic performance studies you are asking about.

To answer your prompt with the available information:

Acceptance Criteria and Device Performance for LumiRex Ureteroscope (as per 510(k) Summary)

Based on the provided FDA 510(k) Premarket Notification (K243532) for the LumiRex Ureteroscope, the "acceptance criteria" and "study" described are primarily focused on the physical and functional performance of the medical device itself, rather than the diagnostic performance of an AI algorithm. The rigorous detail for AI/diagnostic studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies) is not present because this is not an AI-driven diagnostic device.

The clearance is for a ureteroscope, which is a tool for visualization and intervention. Its performance is evaluated against engineering standards and comparison to a predicate device, not against clinical diagnostic accuracy metrics established by human experts reading images with or without AI assistance.

Here's an interpretation of the "acceptance criteria" and "reported device performance" based on the document, framed by the categories you requested, but noting where information is absent due to the nature of the device:

1. Table of Acceptance Criteria & Reported Device Performance

Since the device is a ureteroscope and not an AI/SaMD, the subsequent points of your request are not applicable or details are not provided in this type of 510(k) summary.

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

• Not Applicable in the context of an AI diagnostic test. The "test set" here refers to physical product units subjected to bench testing (e.g., specific endoscopes for image quality testing, or multiple cycles for endurance testing). No specific "sample size" for patient data or cases is mentioned because this is not an AI diagnostic device.
• Data Provenance: Not applicable for diagnostic data as described. The testing is laboratory-based and engineering-focused.

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

• Not Applicable. "Ground truth" in this context (pathology, clinical outcome) is not established or used for the clearance of an endoscope's basic imaging and physical functionality. Experts might be involved in evaluating usability or design, but not for "ground truth" to validate a diagnostic algorithm.

4. Adjudication Method for the Test Set:

• Not Applicable. No diagnostic test set requiring adjudication (e.g., 2+1, 3+1) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. Such a study is typically performed for AI-assisted diagnostic tools. This 510(k) does not describe any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• No. There is no standalone diagnostic algorithm described for this device.

7. The Type of Ground Truth Used:

• Not Applicable. No diagnostic ground truth (e.g., pathology, outcomes data) is used for the clearance of this device as described. Performance is measured against engineering standards and comparison to a predicate device's physical and functional attributes.

8. The Sample Size for the Training Set:

• Not Applicable. There is no AI/machine learning component described that would require a "training set" of diagnostic data.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth establishment method is mentioned.

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The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. 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, optical fibers for transmitting illumination from the LED inside the Handle, 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.

Mechanism of action:
The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera at the distal tip
• LED in the handle and transmitted to the distal tip by optical fibers
• Sterilized by Ethylene Oxide
• For single use

The provided FDA 510(k) clearance letter and summary for the Flexible Ureterorenoscope (K243857) does not contain details about a study evaluating AI performance directly or outlining acceptance criteria for such a study.

This document primarily focuses on the substantial equivalence of a medical device (endoscope) based on its physical properties, performance characteristics (mechanical, optical), electrical safety, biocompatibility, sterilization, and packaging. The "non-clinical tests summary & conclusions" explicitly state "Clinical Testing: Not Applicable."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human reader improvement with AI, or standalone AI performance, as this information is not present in the provided text.

The closest relevant information is about the device's optical performance and image quality, which are foundational for any imaging device, and would implicitly establish a baseline for an AI to process.

Here's what I can provide based on the given information, primarily highlighting the device's tested performance attributes, which serve as foundational acceptance criteria for the hardware itself, not an AI component:

Acceptance Criteria and Device Performance (Flexible Ureterorenoscope - K243857)

Since the provided document is for a medical imaging device (uroscope) and not an AI/software as a medical device (SaMD), the "acceptance criteria" discussed are for the physical and functional performance of the endoscope itself, rather than for an AI algorithm built upon imagery from such a device. There is no mention of AI in this clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "applicable parts" of standards and general categories of testing rather than specific numerical acceptance thresholds or quantitative performance metrics. The reported performance is adherence to these standards and the successful execution of these tests.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for mechanical performance). The testing is primarily bench/lab-based.
• Data Provenance: The tests are non-clinical, hardware-focused performance evaluations. Data is generated during these laboratory tests performed by the manufacturer, Shanghai AnQing Medical Instrument Co., Ltd. (China). This is implied to be prospective testing for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. The document explicitly states "Clinical Testing: Not Applicable." Ground truth, in this context, would relate to clinical outcomes or expert review of images for diagnostic purposes, which are not part of this 510(k) submission for the device itself. Performance is evaluated against engineering standards and specifications.

4. Adjudication Method for Test Set

• Not applicable. No clinical test set or expert review requiring adjudication is mentioned.

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

• No. The document explicitly states "Clinical Testing: Not Applicable." No MRMC study or AI assistance evaluation is mentioned.

6. Standalone Performance (Algorithm Only)

• Not applicable. This submission is for the endoscope hardware, not a standalone AI algorithm. No algorithm performance is described.

7. Type of Ground Truth Used

• Engineering/Technical Standards: The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC, ISO, ASTM, ANSI AAMI) for medical device safety, electrical performance, optical quality, biocompatibility, sterilization, and mechanical integrity. Performance is measured against these technical specifications.

8. Sample Size for Training Set

• Not applicable. There is no mention of an AI component requiring a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. There is no mention of an AI component or a training set.

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This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

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

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

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

This information is not provided in the document as the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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 applicable/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance tests 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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

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Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.

Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.

Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.

The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.

The provided text is for a 510(k) premarket notification for a Single-Use Digital Flexible Ureteroscope (F-URS) and an Electronic Endoscope Imaging Processor. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a submission for a new AI/software device that requires proving clinical benefit.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device is based on substantial equivalence to existing predicate devices, not on specific performance metrics established as acceptance criteria for clinical efficacy. The "acceptance criteria" here refer to meeting recognized standards for medical devices of this type, ensuring safety, and demonstrating that any differences from the predicate do not raise new questions of safety or effectiveness.

Discussion of Differences (from Comparison Table, if differences existed):
The document states for "Maximum insertion portion width(mm)" and "Field of view (degree)" that these are "Similar" or "Same" after analysis, concluding that "Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness." This indicates that any numerical differences in these parameters were evaluated against the relevant standards and found to be acceptable.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no "test set" in the context of clinical data. The testing performed was non-clinical bench testing to demonstrate compliance with recognized industry standards and evaluate engineering performance, biocompatibility, and sterilization effectiveness.

• Sample Size for Bench Testing: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many ureteroscopes were tested for bending angle, how many samples for biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data provenance is from non-clinical laboratory and bench testing, likely conducted by the manufacturer or accredited testing facilities. There is no mention of country of origin for this testing, but it can be inferred the testing supports a device manufactured by Dongguan ZSR Biomedical technology Company Limited in the PEOPLE'S REPUBLIC OF CHINA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical study was conducted, there was no clinical "test set" requiring expert ground truth establishment. The "ground truth" for the non-clinical tests is defined by the objective metrics and thresholds established in the referenced international standards (e.g., ISO, IEC, ASTM).

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring 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

Not applicable. This device is a physical medical instrument (ureteroscope and imaging processor), not an AI/software device. No MRMC study was conducted.

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

Not applicable. This device is a physical medical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is derived from:

• International Standards and Recognized Test Methods: For performance, biocompatibility, and sterility, the ground truth is compliance with the specifications and thresholds defined in the referenced standards (e.g., ISO, IEC, ASTM).
• Predicate Device Characteristics: For determining substantial equivalence, the technological characteristics and performance of the legally marketed predicate device (K230200) serve as a baseline for comparison.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, and no machine learning algorithm development (which would require a training set) is mentioned or implied.

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

Not applicable. There was no training set.

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