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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 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

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

• Not specified in the provided text. The document states that various performance tests were conducted (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) but does not provide details on the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These are typically bench and lab tests, not clinical studies with patient data in the sense of AI/diagnostic algorithms.

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

• Not applicable/Not specified in the provided text. The "ground truth" for these types of engineering and biocompatibility tests is typically established by fulfilling predefined engineering specifications and international standards, rather than expert human interpretation of data in the way medical images are interpreted. No information about experts or their qualifications is provided.

4. Adjudication method for the test set:

• Not applicable/Not specified in the provided text. Adjudication methods like 2+1 or 3+1 are relevant for interpreting medical data (e.g., images) where human judgment might vary. For the performance tests described (e.g., electrical safety, mechanical, biocompatibility), the assessment is typically against objective, quantifiable standards, not subjective expert adjudication.

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, an MRMC comparative effectiveness study was not done. The Ureterorenoscope System is described as a medical device (endoscope) for visual examination and procedures, not an AI or diagnostic assistance tool that would typically involve human readers interpreting output or benefiting from AI assistance.

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

• Not applicable. This device is a physical ureterorenoscope system, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the various performance tests (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) was compliance with established international and national standards (e.g., ISO 10993-1, ISO 11135, IEC 60601 series, ISO 8600 series) and predefined engineering specifications. This is not medical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. The Ureterorenoscope System is a hardware medical device and does not involve AI or machine learning that would require a "training set."

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

• Not applicable. As the device does not involve AI/ML, there is no training set or corresponding ground truth establishment process.

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