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Used for collection of cells in the biliary system.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush and Fusion® Cytology Brush (predicate devices) cleared to market via 510(k) K171573 by Wilson-Cook Medical, Inc.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or an IDE port, a detachable extension line with a leur lock for optional flushing of the wire guide hub and a pinvise handle.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

This document is a 510(k) summary for a medical device (Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device based on modifications and non-clinical bench testing. It does not present a clinical study or performance data related to AI/algorithm performance, which is what your request is specifically asking for regarding acceptance criteria, training/test sets, ground truth establishment, or human reader improvement with AI assistance.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document does not contain any details about:

1. Acceptance criteria and reported device performance (in the context of an AI/algorithm). The "performance data" mentioned here refers to mechanical and material properties, not clinical diagnostic accuracy or AI metrics.
2. Sample sizes used for a test set or data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for a test set for an AI/algorithm.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for an AI/algorithm.
8. Sample size for the training set for an AI/algorithm.
9. How ground truth for the training set was established for an AI/algorithm.

The document states: "Performance testing consisting of non-clinical bench testing that demonstrates the subject devices met the performance requirements to fulfill their intended use. This testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices." This highlights that the evaluation was primarily focused on bench testing for mechanical and material properties, not clinical performance metrics typical for AI-powered diagnostics.

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