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The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (excluding fluoroscopic, angiographic, and mammographic applications).

The FLAATZ 750E is a radlographic image ecquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The FLAATZ 750E system includes a Detector Panel, Control Box, Switch Box, interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Delector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for Image data capture and correction of defects on the image data.

The provided text is a 510(k) summary for the FLAATZ 750E device. It details the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, especially not in the context of AI/ML performance.

The document states: "The FLAATZ 750E has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device." This indicates that the evaluation was likely focused on demonstrating performance comparable to an existing device for general radiography, rather than establishing specific acceptance criteria for AI/ML performance or conducting a comparative effectiveness study with human readers.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Sample sizes or data provenance for a test set for AI/ML evaluation.
3. Number or qualifications of experts for ground truth establishment for AI/ML.
4. Adjudication method for an AI/ML test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results of a standalone AI algorithm performance study.
7. The type of ground truth used for AI/ML (as no AI/ML performance study is mentioned).
8. Sample size for a training set for AI/ML.
9. How ground truth for a training set for AI/ML was established.

This document is a standard 510(k) Pre-Market Notification for a radiographic image acquisition device, which essentially describes a digital X-ray detector system. It is not about an AI/ML-driven diagnostic device.

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