(66 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 consists of High voltage generator (HVG), Ceiling Suspension, X-ray tube, Collimator, Detector, AEC, DAP, CIB(Control Interface Box), Wall Stand, Patient Table, Collimator, Detector, Remote controller, Grid, Foot switch, Barcode scanner and Auto-stitching stand. This 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.
This is a 510(k) premarket notification for the Samsung Electronics Co., Ltd. GC85A Digital X-ray Imaging System. The submission aims to demonstrate substantial equivalence to a predicate device, the XGEO GC80 (K140334).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with specific quantitative thresholds. Instead, the approach is to demonstrate substantial equivalence to the predicate device (XGEO GC80) by showing that the proposed device (GC85A) does not significantly differ in technical characteristics or performance in a way that would raise new questions of safety or effectiveness.
The document highlights differences and provides explanations for why these differences do not negatively impact safety or performance, and importantly, states that non-clinical and clinical data show equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance | Discussion (from document) |
|---|---|---|
| Image Quality (Non-clinical: MTF, DQE measurements) should be equivalent to or not inferior to the predicate device. | "The proposed detectors show curves and measurements of MTF and DQE that do not differ from the predicate device." (Page 8) | "The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." (Page 8) |
| Clinical Image Quality should be equivalent to the predicate device. | "Clinical images were obtained... They were evaluated by a professional radiologist and found to be equivalent to the predicate device." (Page 9) | "These images were evaluated by a radiologist with equivalent U.S. board certification and found to be equivalent to the predicate device." (Page 9) |
| Safety (Electrical, mechanical, environmental) and EMC should meet relevant standards. | "Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards." (Page 8) | This demonstrates compliance with established safety and performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): The document states "clinical images were obtained" (Page 9) but does not specify the sample size (number of images or patients) used for the clinical evaluation.
- Data Provenance: The document implies the data is prospective in the sense that the "proposed GC85A" was used to obtain the clinical images. The country of origin for the clinical data is not explicitly stated, but the manufacturer is based in the Republic of Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One professional radiologist was used.
- Qualifications: "a professional radiologist" and later specified as "a radiologist with equivalent U.S. board certification" (Page 9).
4. Adjudication Method for the Test Set
The document states that "They [clinical images] were evaluated by a professional radiologist" (Page 9). This indicates a single-reader evaluation. Therefore, there was no adjudication method (like 2+1 or 3+1 consensus) used for the clinical image evaluation described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The clinical evaluation involved a single radiologist assessing images from the proposed device against the predicate. This is not an MRMC study comparing human readers with and without AI assistance, as the device itself is an X-ray imaging system, not an AI-powered diagnostic tool. The document focuses on demonstrating that the system produces images equivalent to a predicate.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The GC85A is a digital X-ray imaging system, which means it produces images. Its performance is evaluated on the quality of these images and their equivalence to images from a predicate device, rather than the diagnostic output of an algorithm. Evaluation of "standalone" performance for such a device would pertain to its image acquisition and processing capabilities, which are covered by the MTF and DQE measurements (non-clinical data).
7. The Type of Ground Truth Used
For the clinical evaluation, the "ground truth" was established by expert consensus/opinion (though in this case, a single expert's opinion) comparing the general image quality of the proposed device's images to the predicate device's images. The radiologist "found [the images] to be equivalent to the predicate device."
For the non-clinical data, the ground truth or reference points were standardized measurements (MTF and DQE) as defined by IEC 62220-1.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device described is an X-ray imaging system, not an AI/machine learning device that typically requires a large training set for algorithm development. The development process would involve engineering design and physical testing rather than algorithmic training on vast datasets.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this type of device, this question is not applicable.
§ 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.