(181 days)
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.
The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator, and associated equipment such as tube stand, patient table, and, digital imaging system.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GXR-series diagnostic x-ray system:
It's important to note that the provided document is a 510(k) Summary, which is a regulatory filing for a medical device seeking clearance from the FDA based on substantial equivalence to a predicate device. It typically focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving absolute performance against specific clinical acceptance criteria in a comprehensive clinical study. Therefore, the details provided often lean towards non-clinical testing and comparison with established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating adherence to recognized safety and performance standards, and comparison of technical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if the device meets these standards and is substantially equivalent to the predicate.
Here's a generalized interpretation based on the document's content, focusing on what would typically be implied performance requirements for an X-ray system:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Electrical, Mechanical, Radiation) | Meets international safety and EMC standards (IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-1-2), and 21CFR 1020.30. "No negative impact on safety or effectiveness" reported for differences. |
| Essential Performance (X-ray Generation Parameters) | Output Power Rating (32kW-82kW), Line Voltage (220-230VAC, 380/400/480VAC) are equivalent or within acceptable ranges of predicate. |
| Image Quality (Digital Diagnostic X-ray System) | "State-of-the-art image quality," "excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch" reported. Non-clinical performance data for new flat panel detectors. |
| Software Functionality (Image Processing, User Interface) | "System imaging software 'RADMAX'" updated GUI for "better visibility & faster workflow." Image Processing Module 4 added; "performance verification...concluded no impact on safety and effectiveness." |
| Usability | Adheres to IEC 60601-1-6 (Usability). Operator control console designed to be "simple and user-friendly." |
| Risk Management | Adheres to ISO 14971 (Risk Management). |
| Software Life Cycle Processes | Adheres to IEC 62304 (Software Life Cycle Processes). |
| Compliance with DICOM and Image Compression Standards | Adheres to NEMA PS 3.1-3.20 (DICOM) and ISO IEC10918-1 (Image Compression). |
| Exposure Index of Digital X-ray Imaging Systems | Adheres to IEC 62494-1 (Exposure Index). |
| Substantial Equivalence to Predicate Device (Overall) | "Substantially equivalent in the areas of technical characteristics, general function, application, and intended use," and "does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" sample size in terms of clinical images or patient cases for performance evaluation against specific acceptance criteria. The testing discussed is primarily non-clinical, related to hardware and software verification and validation.
- Data Provenance: The document implies that the testing data is generated from laboratory testing and verification during the development and modification of the device. There is no mention of clinical data or patient data being used for the performance evaluation in this 510(k) summary. Given the context of a 510(k), particularly for an X-ray system, the primary focus is on engineering and performance testing against standards, rather than large-scale clinical studies. The data is thus likely prospective in terms of being generated specifically for this submission but is non-clinical in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As the evaluation is non-clinical, there is no mention of "ground truth established by experts" in the context of diagnostic performance evaluation. The "ground truth" for non-clinical testing would typically be the expected technical output or adherence to a standard, rather than expert interpretation of images.
4. Adjudication Method for the Test Set
This information is not provided as the testing described and implied is non-clinical and does not involve expert adjudication of diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards, not on proving improved reader performance with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This is not applicable in the sense of an AI algorithm's standalone performance. The device is a diagnostic X-ray system, which is inherently designed to be used with a human interpreter (a medical professional). While it has image processing software ("RADMAX"), this software enhances images for human diagnosis, not to provide an automated diagnosis itself.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing is adherence to technical specifications and international standards. For example, for radiation output, the ground truth is that the device delivers the specified kVp and mA, and for electrical safety, that it meets the requirements of IEC 60601-1. For image quality, it refers to intrinsic properties like spatial resolution, MTF, and DQE, which are measured objectively, not subjective expert consensus on diagnostic findings.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is an X-ray imaging system, not an AI/ML diagnostic algorithm that requires a training set of medical images in the conventional sense. The "training" for the device would involve calibration and configuration during manufacturing and installation to ensure it meets its technical specifications. The "RADMAX" software has image processing modules, but the document does not suggest these are deep learning models trained on vast datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. If any parameters for the image processing modules are "learned" or optimized, the document does not elaborate on this process or the ground truth used for such optimization.
§ 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.