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This instrument has been designed to be used with an Olympus video system, light source, accessory equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.

The subject device is used for endoscopic diagnosis and treatment within the urethra, I ho storeet de roo is as optical system is modified from image guide to CCD and the resolution is improved.

The provided text is a 510(k) summary for the OLYMPUS VIDEO URETEROSCOPE, NTSC. It focuses on establishing substantial equivalence to a predicate device based on modifications to an existing device (optical system modified from image guide to CCD, and improved resolution).

This type of submission does not typically include a detailed study with acceptance criteria and device performance results in the way a clinical trial or performance study for a novel high-risk device would. Instead, the focus is on demonstrating that the new device's technological characteristics and performance are comparable to a legally marketed predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of regulatory document. The primary "study" is the comparison to the predicate device.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table. The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K951855, particularly concerning the improved resolution due to the CCD modification.

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

• Sample Size for Test Set: Not specified. This document relies on engineering and performance testing to show equivalence, not typically a clinical "test set" in the sense of a diagnostic algorithm.
• Data Provenance: Not applicable in the context of a 510(k) for an endoscopic device modification. The "data" would be engineering specifications and comparison to the predicate.

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

• Not applicable. Ground truth and expert consensus are not typically part of a 510(k) submission for a device like this, which focuses on hardware changes and their impact on image quality/resolution in comparison to a predicate.

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

• Not applicable.

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 is not an AI-assisted diagnostic device.

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

• Not applicable. This is a hardware device.

7. The type of ground truth used:

• Not applicable in the typical sense of a diagnostic algorithm. The "ground truth" for demonstrating equivalence would be the performance characteristics (e.g., resolution measurements) of both the modified device and the predicate device, against established engineering standards and clinical expectations for visual inspection.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

Summary regarding the "Study":

The "study" cited in this 510(k) is the demonstration of substantial equivalence to the predicate device (A2560, K951855). The primary and explicitly mentioned modification is:

• Predicate Device: A2560 Ureteroscope (K951855)
• Modification: "the optical system is modified from image guide to CCD and the resolution is improved."

The acceptance criteria would have been to demonstrate that the new device performs at least as well as, or better than, the predicate device in terms of image quality and resolution for its intended clinical use, and that any technological differences do not raise new questions of safety or effectiveness. The document itself does not provide the specific data from this comparison but states that the FDA found it substantially equivalent.

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