(56 days)
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The Precision 500D R&F X-ray System consists of an X-ray generator, angulating table with x-ray tube, collimator and image intensifier, wall stand, overhead tube suspension operator console and digital archive system
The provided text describes a 510(k) Summary for the GE Healthcare Precision 500D R&F X-ray System. This document focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML performance metrics, clinical studies with human readers, or detailed ground truth establishment as typically associated with AI-powered diagnostics.
However, based on the non-clinical testing section, we can extract information regarding the device's performance related to dose reduction and image quality (SNR).
Here's the information extracted from the provided text, adapted to your requested format as much as possible, with notes explaining the absence of certain categories:
Acceptance Criteria and Device Performance
This 510(k) Premarket Notification is for an improved version of an existing X-ray system, focusing on dose reduction while maintaining image quality. The "acceptance criteria" presented here refer to the performance targets for dose reduction and Signal-to-Noise Ratio (SNR) in pediatric modes compared to adult modes.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target Performance) | Reported Device Performance |
|---|---|---|
| Dose Reduction (Pediatric Grid-in Mode @ 7.5 fps vs. Adult Grid-in Mode @ 30 fps) | Minimum 35% less dose when measured with a 32cm Image Intensifier (II) or 40cm II system. | Achieves "a minimum of 35% less dose" when measured with a 32cm II or 40cm II system in Pediatric Grid-in mode at 7.5 frames per second (fps) as compared to Adult Grid-in Mode at 30fps. Dose savings represent a minimum specification, averaged over all magnification modes. |
| SNR Difference (Pediatric Grid-in Mode @ 7.5 fps vs. Adult Grid-in Mode @ 30 fps) | Maximum difference in Signal to Noise Ratio (SNR) of 15%. | Quantitatively maintains image quality with "a maximum difference in Signal to Noise Ratio (SNR) of 15%" when comparing Pediatric Grid-in mode at 7.5fps to Adult Grid-in Mode at 30fps. SNR calculations are performed with "Iodine" selected as contrast agent. |
| Dose Reduction (Pediatric Grid-in Mode @ 30 fps vs. Adult Grid-in Mode @ 30 fps) | Minimum 35% less dose when measured with a 32cm II or 40cm II system. | Achieves "a minimum of 35% less dose" when measured with a 32cm II or 40cm II system in Pediatric Grid-in mode at 30fps as compared to Adult Grid-in Mode at 30fps. Dose savings represent a minimum specification, averaged over all magnification modes. |
| SNR Difference (Pediatric Grid-in Mode @ 30 fps vs. Adult Grid-in Mode @ 30 fps) | Maximum difference in Signal to Noise Ratio (SNR) of 15%. | Quantitatively maintains image quality with "a maximum difference in SNR of 15%" when comparing Pediatric Grid-in mode at 30fps to Adult Grid-in Mode at 30fps. SNR calculations are performed with "Iodine" selected as contrast agent. |
Additional Information (as per requested categories):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The testing described is non-clinical bench testing, not a study involving patient data. It refers to measurements performed on the device itself.
- Data Provenance: Not applicable. The data is from internal bench testing of the device, comparing performance characteristics under controlled conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not applicable. Ground truth, in the context of clinical interpretation, is not established for this type of non-clinical, performance-based test. The "ground truth" for dose and SNR measurements is derived from the physical capabilities of the x-ray system and measurement instruments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This was non-clinical bench testing, not an assessment requiring expert adjudication of clinical findings.
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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:
- MRMC Study: No. This submission pertains to an X-ray imaging system, not an AI/ML-powered diagnostic aid involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm-only device. It is a an X-ray imaging system with improved performance characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" for dose measurements would be the actual dose output as measured by calibrated dosimeters, and for SNR, it would be the calculated signal-to-noise ratio based on image measurements under specified phantom conditions.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable. This device does not use an AI/ML model that requires a training set.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.