(14 days)
The Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Revolution XR/d Digital Radiographic Imaging 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 XR/d Digital Radiographic Imaging System consists of an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and tilting radiographic wall stand with integrated digital detector. The configuration can consist of digital table and digital wall stand, digital table only, or digital wall stand only.
This document is a 510(k) summary for the GE Medical Systems Revolution XR/d Digital Radiographic Imaging System. It describes the device, its intended use, and its substantial equivalence to a previously cleared device. Due to the nature of this document (a 510(k) summary focused on substantial equivalence), it does not contain the detailed clinical study information typically found in a full clinical trial report or a more extensive submission for novel devices.
Here's the breakdown of the requested information based solely on the provided text, with explicit notes about what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes the device as being "substantially equivalent" to a previously cleared device (K992066). For devices seeking 510(k) clearance based on substantial equivalence, the primary "acceptance criterion" is often that the new device performs as safely and effectively as the predicate device, or that any differences do not raise new questions of safety or effectiveness. Specific quantitative performance metrics (e.g., sensitivity, specificity, image quality scores) and their associated acceptance thresholds are not provided in this 510(k) summary.
The document states:
- "The Revolution XR/d Digital Radiographic Imaging System is substantially equivalent to the presently marketed Revolution XR/D Digital Radiographic Imaging System (K992066)."
- "The Revolution XR/d Digital Radiographic Imaging System does not include any new indications for use, nor does use of this device result in any new potential hazards."
Therefore, the reported device performance is implicitly considered to be equivalent to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K992066) | Achieved; device is substantially equivalent to Revolution XR/D Digital Radiographic Imaging System (K992066). |
| No New Indications for Use | Achieved; no new indications for use. |
| No New Potential Hazards | Achieved; no new potential hazards. |
| Conformance to applicable sections of 21CFR 1020.30, 1020.31, and 1020.32 | Stated for the system. |
| Conformance to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3 | Stated for the system. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. Given that it's a submission for substantial equivalence to an existing device, it's possible that no new clinical data or a specific "test set" of patient images was explicitly used in the public summary. The focus is on demonstrating that the technical modifications (e.g., new SSXI - presumably a detector technology from the FDA letter) do not alter the fundamental safety and effectiveness of the existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not mentioned in this 510(k) summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid meant to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an imaging system, not a standalone algorithm. Therefore, "standalone" algorithm performance is not applicable and not discussed.
7. The Type of Ground Truth Used
This information is not provided in the 510(k) summary. For a general radiographic system, the "ground truth" would typically refer to the clinical utility of the images produced for diagnostic purposes, which is often inferred from successful use of predicate devices, rather than a specific "ground truth" established for this submission.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document does not describe a machine learning algorithm or a "training set" in the context of this device's submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the 510(k) summary as there is no mention of a training set or ground truth for such in this document.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.