(108 days)
The XGEO GC80 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 XGEO GC80 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), Ceiling suspension, Detector, X-ray tube, Patient table, Wall stand, Collimator and etc.
The provided text describes the Samsung XGEO GC80, a digital X-ray imaging system, and its 510(k) premarket notification. However, the document does not contain specific acceptance criteria, a detailed study description, or performance data in the format requested.
It primarily focuses on establishing substantial equivalence to a predicate device (General Electric Company's Revolution XR/d) by comparing technical characteristics and outlining safety, EMC, and general performance testing against regulatory standards.
Therefore, I cannot fulfill all parts of your request with the input provided. Below is a summary of what can be extracted and what cannot.
Summary of Device Acceptance Information (Based on Provided Text):
The document largely focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for an X-ray system. It does not present a detailed study with specific acceptance criteria and performance metrics for a novel algorithm or diagnostic aid in the way a clinical performance study would.
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as specific performance targets (e.g., sensitivity, specificity, accuracy) for image interpretation. The "acceptance criteria" here implicitly refer to meeting established safety and performance standards relevant to X-ray systems and demonstrating substantial equivalence to a predicate device.
- Implicit Acceptance Criteria:
- Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 (Electrical, mechanical, environmental safety and performance).
- Compliance with IEC 60601-1-2(2001) (EMC testing).
- Demonstration that differences from the predicate device do not introduce new safety risks or negatively impact performance.
- Resolution of detector being "higher than that of the predicate device" for high contrast, which is considered "more advantageous."
- Image stitching functionality providing "more efficiency" for long areas of anatomy without affecting safety.
- Implicit Acceptance Criteria:
- Reported Device Performance:
- "All test results were satisfactory" for the safety, EMC, and performance testing against the listed IEC standards.
- The high contrast resolution of the XGEO GC80's detector is reported to be "higher than that of the predicate device," which is deemed "more advantageous."
- The device is concluded to be "safe and effective and substantially equivalent to predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document does not describe a clinical test set or patient data used to evaluate a diagnostic algorithm's performance. The testing mentioned pertains to engineering, safety, and physical performance of the X-ray system itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. This information would be relevant for evaluating a diagnostic AI algorithm's performance against expert-derived ground truth. The presented text describes a traditional X-ray system, not an AI-powered diagnostic device requiring such expert evaluation in this context.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. As no clinical test set or expert ground truth establishment is described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. This device is a diagnostic imaging system, not an AI-assisted interpretation tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The XGEO GC80 is an X-ray imaging system, not a standalone AI algorithm. It produces images for human interpretation.
7. The Type of Ground Truth Used:
- Not applicable/Not provided. For the system's performance, the "ground truth" corresponds to meeting engineering specifications and regulatory standards via physical tests, rather than a clinical ground truth like pathology or patient outcomes for a diagnostic algorithm.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This information is relevant for machine learning or AI models. This document describes an X-ray system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided. As no training set or AI algorithm is mentioned, this information is not relevant to the document.
In summary: The provided 510(k) summary focuses on demonstrating that the Samsung XGEO GC80 X-ray system is substantially equivalent to a legally marketed predicate device through engineering and regulatory compliance testing. It does not detail a clinical study with acceptance criteria and results related to diagnostic performance as would be expected for an AI-enabled medical device.
§ 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.