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

The Single-use Video Ureterorenoscope (SVU-220US) is intended to be used with the HUGER'S Medical Video Processor (cleared in K230475). 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 provided text is a 510(k) Summary for a medical device (Single-use Video Ureterorenoscope, model SVU-220US), seeking clearance from the FDA. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Single-use Video Ureterorenoscope, model SVU-220).

This document does not describe the specific acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The information provided is for a ureteroscope, which is an optical instrument, not an AI or computer-aided detection/diagnosis (CADe) device.

Therefore, many of the requested details about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to the information contained in this 510(k) summary.

However, I can extract information related to the device's performance testing and the comparison made for demonstrating substantial equivalence.

Here's a breakdown of the relevant information from the document, acknowledging the limitations regarding AI/CADe systems:

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

The document does not explicitly present "acceptance criteria" in the format of a table with specific thresholds for image quality or clinical performance that would be typical for an AI/CADe device. Instead, it states that the subject device (SVU-220US) and its predicate (SVU-220) comply with various standards to demonstrate performance and safety. The equivalence is primarily based on the devices being "exactly the same" in fundamental technology, optical and physical characteristics, structure, sterilization methods, and components, with one minor difference in deflection marking.

Implicit "Performance" aspects (compared to predicate or standards):

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

• Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation in a quantitative manner as would be done for an AI/CADe. The information provided heavily relies on direct comparison to the predicate device and compliance with general standards. For biocompatibility and optical/physical testing, it states tests were performed on the "predicate device" or "aged/unaged Single-use Video Ureterorenoscope (SVU-220)", implying a sample was used but the size (N) is not given.
• Data Provenance: Not specified. The manufacturer is based in Shanghai, China. The document does not indicate if the performance testing data was gathered retrospectively or prospectively, or the country of origin of the physical testing.

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 device is a direct imaging instrument, not an AI/CADe system requiring expert ground truth for classification or detection tasks. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against defined industry standards.

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

• This is not applicable for the type of device and performance testing 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 MRMC study was done, as this is not an AI-assisted device.

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

• Not applicable; this is an instrument, not an algorithm.

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

• The "ground truth" for this device revolves around its physical characteristics, material composition, optical performance, and biocompatibility conforming to established international standards (e.g., ISO, ASTM, IEC). There is no "patient outcome" or "pathology" ground truth discussed in the context of validating the device's core functionality as an endoscope. Its function is to provide video imaging to a physician, who then uses clinical judgment.

8. The sample size for the training set

• Not applicable; this device does not involve a "training set" as it is not an AI/machine learning product.

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

• Not applicable for the same reason as above.

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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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