(80 days)
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner and Main cable. 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 retrofit system consisting of Detector, Power supply box, Battery charger, Access point, CIB (Control Interface Box), Workstation, Barcode scanner and Main cable. This retrofit system is designed to generate a digital image while using the current analogue X-ray system by upgrading only the part of an analogue cassette film to the digital panel(detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.
The GR40CW retrofit system can be applied to the existing analogue X-ray system by two ways (CIB and AED modes). 1) In CIB mode, CIB is only connected to a signal line of a hand switch for passively detecting the signal, as On or Off, coming out from the hand switch to the X-ray Generator Console, to make the digital detector ready to active or inactive to receive X-ray radiation. 2) In AED (Automatic Exposure Detection) mode, without CIB, the detector is sensing of radiation exposure. Once it recognizes the exposure, it become active right away to receive X-ray radiation. This whole process is independently operated from the existing analogue X-ray system.
This document describes the 510(k) Pre-market Notification for the SAMSUNG ELECTRONICS Co., Ltd. GR40CW Digital X-ray Imaging System (K152094), which is seeking substantial equivalence to the predicate device XGEO GR40CW (K140235).
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence by analyzing technological characteristics and non-clinical performance data, rather than defining specific acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity) for a particular clinical task. The "acceptance criteria" here are implicitly tied to demonstrating that the proposed device performs "as well as" or is "substantially equivalent" to the predicate device in terms of image quality and safety.
The document states: "In non-clinical data, the proposed detector shows curves and measurements of MTF and DQE that improved from the predicate device, and the proposed GR40CW has been shown a substantially equivalent or improved to the predicate device." And elsewhere: "The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." These statements appear somewhat contradictory or at least imprecise. Good practice would involve specific numerical targets for MTF and DQE or clearly defined thresholds for "improvement" or "no difference."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MTF and DQE performance | Improved from the predicate device (also stated "no difference") |
| Electrical safety | Satisfied ES 60601-1(2012) |
| EMC | Satisfied IEC 60601-1-2(2007) |
| Wireless function | Verified according to FDA guidance |
| Conformance to Standards | ISO14971, ISO13485, 21 CFR Subchapter J 1020.30 and 1020.31 |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "12.Clinical data: Not required since the different detector area, CPU and Memory specification, and a new CIB do not have relation to and affect the clinical images of the detector which was cleared with the predicate device."
Therefore, no clinical test set (i.e., for evaluating diagnostic performance on patient data) was used. The focus was on non-clinical engineering and image quality performance data to establish substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth establishment was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
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
Not applicable. This submission is for a digital X-ray imaging system, not an AI-powered CAD (Computer-Aided Detection) or diagnostic assistance device. Therefore, no MRMC study assessing human reader improvement with AI was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is an imaging acquisition device, not an algorithm for diagnosis or detection.
7. The Type of Ground Truth Used
For the non-clinical performance data (MTF, DQE), the "ground truth" would be established by the physical and technical specifications of the detectors and measurement protocols (e.g., JEC 62220-1). It's not a clinical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
Not applicable, as this is an imaging acquisition device. The submission does not describe a machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
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.