(120 days)
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GC85A digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
The Image Post-processing Engine is exclusively installed in S-station, which is a Samsung Digital X-ray Operation Software for Samsung Digital X-ray System. It has an image processing algorithm to improve an acquired image and previously cleared with K160997.
The proposed Image Post-processing Engine is upgraded with employing an advanced noise reduction algorithm to improve image quality. The proposed Engine is shown of a post-processed image as substantially equivalent as the image by the predicate Image Post-processing Engine at a certain low dose level.
The acceptance criteria and the study proving the device meets them are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device is an upgraded Image Post-processing Engine for the GC85A Digital X-ray Imaging System, featuring an advanced noise reduction algorithm. The primary acceptance criterion is achieving substantially equivalent image quality at a 50% reduced radiation dose compared to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Image quality substantially equivalent to predicate device with 50% dose reduction (for PA radiograph for average adult chest). | Phantom study: Images using the proposed engine, taken at 50% reduction in radiation dose, are substantially equivalent to those using the predicate engine. Clinical study: Images using the proposed engine taken at 50% reduction in radiation dose are substantially equivalent to those using the predicated engine without sacrificing diagnostic confidence. |
| Improved image quality (noise reduction, distinction between background and object, clarity) | SNR and CNR measured to determine image quality showed overall images using the proposed engine make it easy to distinguish between background and the object and is clearer than images using the predicated engine. |
| Maintained diagnostic confidence | Clinical study confirmed that diagnostic confidence was not sacrificed with the 50% dose reduction images. |
| Conformance to safety and performance standards (Electrical, mechanical, environmental, EMC, wireless function) | All test results were satisfying the standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2. Wireless function tested and verified. |
| Conformance to FDA guidance for Solid-State X-ray Imaging Devices (MTF and DQE measurements) | Non-clinical testing data provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices," including MTF and DQE measurements as tested by IEC 62220-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Study: 78 in-vivo data sets of chest PA images.
- Phantom Study: Not explicitly stated as a number, but "a semi-anatomical chest phantom at a various radiation dose" and "anthropomorphic chest phantom images" were used.
- Data Provenance: The clinical study was conducted at "one facility" and involved "in-vivo data sets." This implies the data is prospective clinical data collected specifically for this study. The country of origin is not explicitly mentioned but the submitter is from the Republic of Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three professional radiologists.
- Qualifications: "Three experienced radiologists." Specific years of experience are not provided, but they are described as "professional" and "experienced."
4. Adjudication Method for the Test Set
- The text mentions that "Anthropomorphic chest phantom images were scored by Bureau of Radiological Health (BRH) method and inter-observer agreement was calculated."
- For the clinical images, "Seven anatomical landmarks were evaluated for image quality assessment by three readers."
- While it states that inter-observer agreement was calculated for phantom images and multiple readers evaluated clinical images, it does not explicitly describe a specific adjudication method like 2+1 or 3+1 for resolving discrepancies in reader interpretations for either phantom or clinical studies. It implies a consensus or agreement was sought, but the formal process isn't detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- A MRMC study comparing human readers with AI vs. without AI assistance was not conducted. The study evaluated whether images processed by the new engine at reduced dose were substantially equivalent to those from the predicate engine, evaluating the device's standalone performance in producing equivalent diagnostic images, rather than its assistive role to humans.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone evaluation of the algorithm's output was critically performed. The primary goal was to demonstrate that the images generated by the new Image Post-processing Engine at 50% dose reduction are diagnostically equivalent to those from the predicate device at full dose. This means the algorithm's ability to process images to an acceptable diagnostic quality was the focus, rather than its interaction with a human reader. SNR and CNR measurements and the radiologists' evaluations of image quality were direct assessments of the algorithm's output.
7. The Type of Ground Truth Used
- The ground truth was established through expert consensus/reader interpretation (three experienced radiologists) during the evaluation of both anthropomorphic phantom images (scored by BRH method) and clinical images (evaluation of seven anatomical landmarks and 18 cases of featured lung lesions). There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for the training set used to develop or train the advanced noise reduction algorithm in the Image Post-processing Engine.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. It focuses primarily on the testing and validation of the device's performance.
§ 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.