(25 days)
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand.
These systems are 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 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 GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685).
The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.
The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.
The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image.
These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.
The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or reported device performance metrics in the format requested. The document is a 510(k) premarket notification summary for an X-ray imaging system, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an analysis of what can be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document refers to conformance with various 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 62220-1) and a guidance document for wireless technology. It also states that all test results were "satisfying the standards." However, specific numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) for the software features are not detailed.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device, or its software features (SimGrid, BSI, TLE). It only mentions that MTF and DQE measurements "show no difference in non-clinical testing data... from the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document states "The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data." This implies no clinical test set was used for the substantial equivalence demonstration of these specific software features. Non-clinical testing data (MTF and DQE) likely used phantoms, but the sample size or provenance of that data is not provided.
3. 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)
- Not applicable as no clinical data or specific test set adjudicated by experts is described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical data or specific test set with expert adjudication is described in the document.
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 is mentioned. The document explicitly states that clinical data was not required for the software features in question.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the software features (SimGrid, BSI, TLE) provide "companion images to assist diagnosis." This suggests an assistive role rather than a standalone diagnostic role, but no specific performance metrics for this assistance are provided. The fact that clinical data was not required for these features further supports that a standalone performance study was not conducted for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no clinical studies with established ground truth are described for the performance of the features. For non-clinical MTF and DQE measurements, the ground truth would be determined by the phantom properties and measurement protocols per IEC 62220-1.
8. The sample size for the training set
- Not specified. The document describes the device as a hardware system with added post-processing software features. There is no mention of an "AI" or "machine learning" algorithm in the modern sense that would require a distinct training set. The software features (SimGrid, BSI, TLE) are described as "post-image processing software option" rather than adaptive learning algorithms.
9. How the ground truth for the training set was established
- Not applicable, as a training set for an AI/ML algorithm is not described.
§ 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.