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510(k) Data Aggregation
(63 days)
The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.
This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.
This document is an FDA 510(k) summary for the Galaxy R Digital Radiography Upgrade, a device intended to replace radiographic film/screen systems in general-purpose diagnostic procedures (excluding mammography). The submission aims to demonstrate substantial equivalence to the predicate device, Atlaim ATAL 8C (K113812).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" is not explicitly defined in terms of specific performance thresholds that the device must meet in a formal, quantifiable sense within this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved through a comparison table highlighting technological characteristics. The "performance" is implicitly compared to the predicate, with minor differences deemed not to have a material effect on safety or effectiveness.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Galaxy R Digital Radiography Upgrade) | Conclusion (Relative to Predicate) |
|---|---|---|---|
| Indications for Use | For generating radiographic images of human anatomy, to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications. (ATAL 8C) | For generating radiographic images of human anatomy, to replace a radiographic film/screen system in all general-purpose diagnostic procedures. Not for mammography. | SAME |
| Panel Communication | Tethered Gigabit Ethernet, one panel (ATAL 8C) | SAME | SAME |
| Sensor Type | a-Si TFT array Panel detector (ATAL 8C) | a-Si TFT array Panel detector | SAME |
| Scintillator | CSI & GOS (ATAL 8C) | CSI & GOS | SAME |
| Panel Resolution | 3072 x 3072 pixels, 3.1 lp/mm (ATAL 8C) | 3,072 x 3,072 pixels, 3.7 lp/mm. Also available in 3072x2560 pixels (14 x 17 size). | SAME (with additional size option) |
| Panel Size | 17" X 17" (ATAL 8C) | 17" X 17" SAME or available in 14" x 17" | SAME (with additional size option) |
| Weight | 3.8kg (ATAL 8C) | 3.3 kg or 2.9kg (14 x 17) | NOT A MEANINGFUL DIFFERENCE |
| Pixel Size | 139 μm (ATAL 8C) | 140 μm | NOT A MEANINGFUL DIFFERENCE |
| Image Depth | 16 bits (ATAL 8C) | 16 bits | SAME |
| Preview Image | 2-5 seconds (ATAL 8C) | Less than 3 seconds | EQUIVALENT |
| DICOM | Yes (ATAL 8C) | SAME | SAME |
| Safety/EMC | EN/IEC 60601-1, Safety; EN/IEC 60601-1-2 EMC (ATAL 8C) | SAME, plus tested to IEC 60601-1-6, Medical electrical equipment, Part 1-6: General requirements for safety - Collateral Standard: Usability, including IEC 62366: Application of usability engineering to medical devices. | SAME (with additional testing for usability) |
| Operating Environment | 10°-35°C, 20%-75% RH (non-condensing) (ATAL 8C) | Sensor unit: 10-35°C, 40-80% RH (non-condensing) | EQUIVALENT |
| MTF @2 lp/mm | 28% CSI, 22% GOS (ATAL 8C) | 25% CSI, 20% GOS | Slightly lower than predicate, but implied as a non-meaningful difference. |
| Trigger | Auto sense or manual (ATAL 8C) | SAME | SAME |
| Power Source | 100-250V ~ 50/60Hz 250V ~ (ATAL 8C) | 100-250V ~ 50/60Hz 250V | SAME |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): Not explicitly stated with a specific number of images. The document states "Clinical images of actual patients were submitted."
- Data Provenance: Not explicitly stated (e.g., country of origin). The images were from "actual patients," implying retrospective or prospective clinical acquisition, but the specific study design for the clinical images is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Singular, "Board Certified Radiologist."
- Qualifications of Experts: "Board Certified Radiologist." No specific experience in years is mentioned.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the clinical images "were evaluated by Board Certified Radiologist and found to be of excellent diagnostic quality." This implies a single expert review for quality, not a consensus-based adjudication for ground truth for diagnostic accuracy.
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
No MRMC comparative effectiveness study was mentioned. The device is an upgrade to a digital radiography system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "non-clinical tests" section describes bench testing for imaging characteristics like MTF and DQE, which are measurements of the device's technical performance independent of human interpretation. The "clinical images" were used to show the complete system works as intended, evaluated by a radiologist. This suggests standalone performance of the image acquisition hardware, with a human validating the output quality.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (MTF, DQE), the "ground truth" is derived from physical measurements and technical standards in accordance with the FDA Guidance Document on Solid State Imaging Devices.
For the clinical images, the ground truth is expert opinion/evaluation by a single Board Certified Radiologist, who deemed them to be "of excellent diagnostic quality." This is a qualitative assessment of image quality for diagnostic purposes, not a definitive ground truth for specific pathologies or outcomes.
8. The Sample Size for the Training Set
The document does not mention any training set. This device is a digital radiography upgrade, not an AI/machine learning algorithm requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this type of device submission.
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