(26 days)
The GF50A 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 GF50A digital X-ray imaging system consists of High voltage generator (HVG), Tube Stand, Wall Bucky Stand, Patient table, Detector, X-ray tube, Collimator, Automatic Exposure Control(AEC), Dose Area Product(DAP), Control Interface Box (CIB), Grid and Barcode scanner.
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 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 provided document is a 510(k) Premarket Notification for the SAMSUNG ELECTRONICS Co., Ltd. GF50A Digital X-ray Imaging System. It focuses on demonstrating substantial equivalence to a predicate device (XGEO GF50, K140326) primarily through non-clinical data, as clinical data was deemed not required.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for rigorous clinical studies. Instead, it relies on demonstrating that the non-clinical performance (MTF and DQE) of the proposed device is not different from the predicate device. The underlying acceptance criterion for this submission appears to be substantial equivalence in non-clinical performance to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-clinical equivalence in imaging performance. Specifically, MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) measurements should not differ from the predicate device. | "the proposed detector shows curves and measurements of MTF and DQE that do not differ from the predicate device" |
| and | |
| "The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." | |
| Safety and Technical Standards Compliance. | Electrical, mechanical, environmental safety, and EMC testing performed according to ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31. Wireless function test followed FDA guidance. |
| "All test results were satisfying the standards." | |
| No adverse impact due to differences in HVG. | The differences in HVG (Max Power, Tube Voltage, Tube Current) "do not contribute any adverse impacts to the device's safety and performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for a human subject test set, as no clinical data was required or provided for this 510(k) submission. The evaluation was based on non-clinical data. For the non-clinical tests (MTF, DQE), the sample size would typically refer to the number of detectors or measurement points, but this information is not specified.
- Data Provenance: The testing was presumably conducted by the manufacturer, SAMSUNG ELECTRONICS Co., Ltd., in the Republic of Korea (their stated address). The data is non-clinical (measurements from physical devices) rather than retrospective or prospective human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No human expert ground truth was established for a test set, as no clinical data or human-in-the-loop performance study was conducted. The "ground truth" for the non-clinical tests (MTF, DQE) is based on objective physical measurements and established international standards (IEC 62220-1).
4. Adjudication Method for the Test Set
Not applicable. There was no adjudication method as no clinical test set requiring expert review or consensus was utilized. The assessment was based on objective non-clinical measurements.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data: Not required since the difference of Max Power, Tube Voltage and Current of HVG does not affect the clinical images of the detector which was cleared with the predicate device." Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned, and human reader performance was not evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. The device is an X-ray imaging system, not an AI algorithm. The performance evaluation concentrated on the physical characteristics and safety of the X-ray system itself.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical data relies on objective physical measurements (MTF, DQE) conforming to international standards (IEC 62220-1). It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is an X-ray system, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for an AI algorithm.
§ 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.