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The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.

Subject Devices:
Model A2765 Working element, for probes
Model A0561 Guiding tube, for probes, with retractor
Model A0562 Guiding tube, for probes
Model A2891 Injection cannula, 1,2 mm x 420 mm

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Olympus Working Element for Probes.

Crucially, the provided document is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than presenting detailed, independent clinical studies with specific acceptance criteria and performance metrics like those for a novel AI device.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI-specific metrics is not available in this type of regulatory document. This summary primarily outlines the device's intended use and lists predicate devices.

Let's break down what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are stated, nor is there a report of device performance against such criteria.

This document is a 510(k) premarket notification, which establishes substantial equivalence through comparison to legally marketed predicate devices, not through a formal clinical trial with quantitative performance outcomes and pre-defined acceptance criteria. The "performance" demonstrated is implicitly that the device is as safe and effective as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a "test set" in the context of an AI or diagnostic performance study. The 510(k) process relies on equivalence to predicate devices, material safety, and functionality, not a clinical study on a specific test set.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. There is no mention of a study involving experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is more common for evaluating diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This document is for a medical instrument, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical working element for endoscopic procedures, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. As a mechanical device, the "ground truth" concept in the statistical sense for diagnostic or AI performance does not apply. Safety and efficacy are typically established through engineering tests, biocompatibility, sterilization validation, and comparison to predicate devices, not "ground truth" derived from patient data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is irrelevant.

In summary: The provided 510(k) document is a regulatory submission for a medical instrument. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment, which are typical for diagnostic or AI-powered devices.

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