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The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.

The provided text is a 510(k) summary for the XiScan 4000 Imaging System, which is a fluoroscopic mini C-arm system. It seeks substantial equivalence to a predicate device, the XiScan 6000 Imaging System.

Based on the information provided, it is not possible to complete the request. Here's why and what information is missing:

This document is a regulatory submission for a medical imaging device. It focuses on demonstrating substantial equivalence to a previously cleared device, not on presenting a detailed study with acceptance criteria for device performance as would be done for a novel AI-powered diagnostic tool. The "study" mentioned here is a bench test comparison to establish equivalence, not a clinical performance study against established ground truth.

Here's a breakdown of why each requested point cannot be answered:

1. Table of acceptance criteria and reported device performance: This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the XiScan 4000. It states the devices have "similar technique factors, SIDs, field-of-view sizes, and image enhancement options" and that "patient X-ray exposure rates for imaging various anatomies are similar." This is the extent of the "performance" discussed, and it's relative to the predicate, not against absolute metrics.

2. Sample size for the test set and data provenance: No test set in the context of diagnostic performance (e.g., images for classification, images with known disease states) is mentioned. The "bench test comparison" likely involved physical measurements and phantom studies, not a "test set" of patient data.

3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment by experts is mentioned because no diagnostic performance study is described.

4. Adjudication method for the test set: Not applicable, as no diagnostic test set is detailed.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool. No comparison of human readers with or without AI assistance is present.

6. Standalone (algorithm-only) performance: Not applicable. This is a hardware imaging system, not an algorithm.

7. Type of ground truth used: Not applicable. No diagnostic performance study against ground truth (e.g., pathology, outcomes) is described.

8. Sample size for the training set: Not applicable. This is a hardware device; there is no mention of a "training set" in the context of an AI algorithm.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document describes a regulatory pathway for a conventional medical imaging device, focusing on substantial equivalence to a predicate. It does not contain the type of AI/diagnostic algorithm performance data that would allow for completion of the requested table and information.

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