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The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.

Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:

• Transurethral inspection of the ureters and renal pelvis for diagnosis
• Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
• Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
• Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.

The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.

The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels.

The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use.

The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.

This document is a 510(k) summary for the Olympus OES Elite Ureteroscopes and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or AI performance metrics.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone AI performance, etc., cannot be directly extracted from the provided text. The document pertains to the device's physical and optical characteristics and reprocessing validation, not an AI component.

However, I can extract the acceptance criteria and performance data that are present in the document, which relate to the ureteroscope's physical and optical properties.

Here's the information that can be derived from the text, formatted as closely as possible to your request, but acknowledging the limitations for AI-specific data:

Acceptance Criteria and Device Performance for Olympus OES Elite Ureteroscopes and Accessories

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

The document presents a comparison of the subject device (OES Elite Ureteroscopes) to predicate devices, implying that the subject device's performance is acceptable if it is comparable to or better than the predicate, and does not raise new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and the internal design specifications of the new device that were verified.

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical performance and verification tests to ensure the subject devices function as intended and meet design specifications, as well as being substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "nonclinical testing," "design verification and validation testing," and "comparative testing" of the physical devices. Data provenance is implied to be from internal testing by the manufacturer (Olympus Winter & Ibe GmbH). The nature of these tests (e.g., mechanical, optical) means they are conducted in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for device performance (e.g., resolution, dimensions, flow rate) is established through standardized engineering and laboratory measurements, not through expert human interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set
Not applicable, as ground truth is based on direct measurement and engineering standards, not subjective expert assessment.

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 is for a medical device (ureteroscope), not an AI-powered diagnostic or assistive tool. No human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device.

7. The type of ground truth used
The ground truth for the device's physical and optical characteristics is based on engineering specifications, direct measurements, and adherence to established international and national standards (e.g., ISO 8600 series for endoscopes, IEC for electrical safety, ASTM for transport, ISO 10993 for biocompatibility, FDA guidance for reprocessing).

8. The sample size for the training set
Not applicable. There is no AI "training set" for this device.

9. How the ground truth for the training set was established
Not applicable. There is no AI "training set" for this device.

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