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

The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing.

The single-use Ureterorenoscope 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 Ureterorenoscope and outputs video signals to a display.

The provided text is a 510(k) summary for the Ureterorenoscope System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on bench performance, biocompatibility, sterilization, and electrical safety.

Crucially, the document explicitly states "Clinical study: Not applicable." This means that the submission did not include a study that proves the device meets specific acceptance criteria based on clinical performance with human subjects, especially concerning AI-driven functionalities for diagnosis or assistance.

Therefore, I cannot provide details regarding acceptance criteria for a study related to AI performance, sample size for a test set, ground truth experts, adjudication methods, MRMC studies, or standalone algorithm performance, as such a study was not part of this 510(k) submission.

The "performance data" section (Section 8 of the 510(k) summary) details various engineering and safety tests, not clinical efficacy or AI performance.

Below is a breakdown of what can be extracted from the provided text regarding device performance, categorized to best fit your request, while acknowledging the absence of AI-specific clinical study data.

Table of Acceptance Criteria and Reported Device Performance (Based on Bench Testing and Safety Standards)

Since no clinical study data for AI performance is present, the "acceptance criteria" here refer to compliance with various engineering, safety, and manufacturing standards. The "reported device performance" indicates that the device met these standards.

Regarding AI-Specific Questions (Not Applicable Based on Provided Text):

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI study is provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth data from an AI study is provided.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set data from an AI study is provided.
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. The document explicitly states "Clinical study: Not applicable."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical ureterorenoscope system, not a standalone AI algorithm for diagnostic interpretation in this submission.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance. The ground truth for bench testing is defined by engineering specifications and measurements against the predicate device.
7. The sample size for the training set: Not applicable. There is no mention of an AI training set.
8. How the ground truth for the training set was established: Not applicable. There is no mention of an AI training set or its ground truth establishment.

In summary, this 510(k) submission for the Ureterorenoscope System focuses on the physical and functional aspects of the endoscope and image processor, along with compliance to relevant safety and performance standards, rather than clinical performance from an AI perspective.

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The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.

The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Flexible insertion portion
• Camera and LED light source at the distal tip

The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.

However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.

Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.

Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.

Based on the provided text, here is what can be inferred:

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

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.

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The Ureterorenoscope System consists of a sterile single-use Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary track and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Ureterorenoscope System consists of a sterile single-use Flexible Ureteroscope to be introduced within the urinary tract and a non-sterile repeat use Video Processor for clinical image processing.

The provided document is a 510(k) Summary for the AnQing Medical Instrument Co., Ltd. Ureterorenoscope System (K201293). This document declares no clinical performance data was required or conducted to demonstrate substantial equivalence to the predicate device. Therefore, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt regarding acceptance criteria and a study proving the device meets those criteria with specific performance metrics, sample sizes, expert qualifications, or ground truth details.

The document focuses on non-clinical performance data and a comparison to a predicate device (Shanghai AnQing Medical Ureterorenoscope System K180367) to establish substantial equivalence.

Here's a breakdown of the relevant sections from the document that explain why no clinical study or specific performance criteria are described:

• Non-Clinical Performance Data: "The subject and predicate devices have the same fundamental technology, insertion section length, field and direction of view, light source, image display, number of uses and sterilization. The subject ureteroscope differs from the predicate in patient-contacting materials, and size of the primary package. These differences do not raise different questions of safety and effectiveness as compared to the predicate."
• Non-Clinical Performance Data (cont.): "As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the endoscope material changes and package size change. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K180367). The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device."
• Clinical Performance Data: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
• Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Ureterorenoscope System is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested table or study details because the submission states that no clinical studies were performed for this 510(k) clearance. The device's substantial equivalence was based on non-clinical bench testing and comparison to a predicate device, focusing on material and packaging changes.

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The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device 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 Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.

The provided text describes a 510(k) premarket notification for a Ureterorenoscope System. It outlines the device, its indications for use, comparison with predicate devices, and performance data provided in support of substantial equivalence. However, it does not contain information related to acceptance criteria, specific study designs, or performance metrics in a way that would allow for a detailed response to all aspects of your request.

Specifically, the document discusses "performance data" in general terms, such as "Biocompatibility testing," "Sterilization and shelf life testing," "Electrical safety and electromagnetic compatibility (EMC)," "Software Verification and Validation Testing," "Optical performance testing," and "Mechanical performance testing." It states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies with" various ISO and IEC standards for other tests, but it does not provide:

• A table of specific acceptance criteria and reported device performance values. It only gives broad statements of compliance.
• Sample sizes used for test sets or data provenance for these performance tests (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for AI/diagnostic support systems, which this device is not described as.
• If a standalone (algorithm only) performance study was done. This is not an AI algorithm; it's a medical device.
• The type of ground truth used (e.g., pathology, outcomes data). While it mentions testing, it does not specify how "ground truth" was established for, say, optical or mechanical performance beyond compliance with standards.
• Sample size for the training set. This is not an AI device that would typically have a "training set" in the machine learning sense.
• How ground truth for the training set was established.

Therefore, based on the provided text, I can only extract the following limited information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

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