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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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