(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 Auto-stitching 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 provided text is a 510(k) Premarket Notification for the SAMSUNG ELECTRONICS Co., Ltd. GU60A & GU60A-65 Digital X-ray Imaging Systems. This document primarily focuses on establishing substantial equivalence to a predicate device (XGEO GU60A, K140332) rather than providing detailed acceptance criteria and a comprehensive study report for the device's performance.
Therefore, the requested information cannot be fully extracted. Here's a breakdown of what can and cannot be provided based on the given text:
Information that can be extracted, partially or fully:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly presented in a table format with specific quantitative acceptance criteria or detailed device performance metrics. The document states that "All test results were satisfying the standards" for safety, EMC, and performance, and "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." It also mentions "A Clinical images review report...which shows the equivalent diagnostic capability to the predicate device." However, no specific numerical or statistical acceptance criteria for diagnostic capability are provided.
- Data Provenance (country of origin, retrospective/prospective): Not specified for the clinical images review.
- Ground Truth (type of): The "Clinical images review report" implies expert consensus from a qualified reviewer for diagnostic capability, but specific details about how ground truth was established are not provided.
- Standalone Performance: The "Non-clinical data" section describes testing such as MTF and DQE measurements (IEC 62220-1), which are measures of a device's standalone performance. The document states "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."
Information that cannot be extracted from the provided text:
- Sample size for the test set: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
- Effect size of human readers with vs without AI assistance: Not applicable as no AI component is described.
- Sample size for the training set: Not mentioned. This device does not appear to utilize AI/ML, so a "training set" in that context would not be relevant.
- How the ground truth for the training set was established: Not applicable.
Based on the available text, here's what can be reported:
1. A table of acceptance criteria and the reported device performance
Since specific quantitative acceptance criteria and detailed device performance for diagnostic capability are not provided, this table will reflect the general statements made in the document regarding equivalence and compliance.
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety, EMC, and General Performance | Compliance with 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. EMC testing according to IEC 60601-1-2. Wireless function tested per guidance. | "All test results were satisfying the standards." |
| Non-clinical Imaging Performance (MTF, DQE) | Equivalence to predicate device (XGEO GU60A, K140332) as measured by IEC 62220-1. | "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." |
| Clinical Diagnostic Capability | Equivalent diagnostic capability to the predicate device (XGEO GU60A, K140332). | "A Clinical images review report...shows the equivalent diagnostic capability to the predicate device." (No specific quantitative metrics or thresholds are provided for this equivalence.) |
| Safety and Performance Risks | No introduction of new potential safety & performance risks compared to predicate. | "The proposed GU60A & GU60A-65 devices...do not introduce any new potential safety & performance risks, and the proposed devices are substantially equivalent to and performs as well as the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The company is based in the Republic of Korea, but the origin of the clinical images for review is not stated, nor is whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, although a "qualified/trained doctor or technician" is mentioned in the Indications for Use for operating the system. The "clinical images review report" implies a qualified reviewer, but details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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, nor is any AI component described for the device. The device is a digital X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, standalone performance testing was done for the physical imaging components.
- "Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1."
- The results indicated that "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "Clinical images review report" implies expert consensus or review by qualified individuals for assessing "equivalent diagnostic capability." However, the exact nature (e.g., specific clinical endpoints, pathology correlation) used to establish ground truth for this review is not detailed.
8. The sample size for the training set
- Not applicable/Not mentioned, as the document describes a hardware device (X-ray system) and not an algorithm requiring a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned, for the same reason as above.
§ 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.