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The Revolution TX/ Digital Radiographic Table System 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. This device is not intended for mammographic applications.

The Revolution TX/i Digital Radiographic Table System is designed to perform radiographic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Revolution TX/i Digital Radiographic Table System consists of a an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, and generator. A separate, conventional SG100 vertical bucky stand is provided for chest or other general purpose radiographic procedures.

The provided text is a 510(k) summary for the GE Medical Systems Revolution TX/i Digital Radiographic Table System. It states that the device is substantially equivalent to a predicate device and does not contain detailed acceptance criteria or a comprehensive study report with the requested specifics.

Here's a breakdown of the information that can be extracted versus what is not available from the provided text, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available: The document does not specify acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores, etc.) nor does it report specific device performance against such criteria.

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

• Not available: No information is provided about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective).

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

• Not available: Since no specific test set or performance evaluation is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set

• Not available: No information on an adjudication method for a test set is provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.

• Not available: The document does not mention an MRMC study or any effect size related to human reader improvement with or without AI assistance. The device predates widespread AI integration in such systems.

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

• Not available: This is a hardware system, not an AI algorithm, so a standalone performance study in that context is not applicable and not mentioned.

7. The type of ground truth used

• Not available: No ground truth methodology is described, as a formal performance study against a specific clinical condition is not presented.

8. The sample size for the training set

• Not available: Since this is a hardware device submission focusing on substantial equivalence, there is no mention of a "training set" in the context of an algorithm.

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

• Not available: As above, no training set is discussed.

Summary of the "Study" Mentioned in the Document:

The document states:

• "Summary of Studies: The device has the same detector and acquisition system as the predicate device, and the same intended uses. It will be evaluated for conformance with UL and IEC safety standards. We consider the device to be substantially equivalent to the predicate device."

This indicates that the "study" conducted for this 510(k) submission was primarily a comparison to a predicate device to establish substantial equivalence, focusing on:

• Identical detector and acquisition system.
• Identical intended uses.
• Conformance with UL and IEC safety standards.

It is not a clinical performance study in the sense of demonstrating diagnostic accuracy against a ground truth for specific clinical conditions, but rather a demonstration that the new device functions similarly and is as safe as a previously cleared device. The conclusion states that the TX/i system provides "radiographic images that result in equivalent or better diagnostic capabilities than film / screen images," but this is a general statement of equivalence rather than a result from a specific comparative clinical trial detailed in this document.

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