(248 days)
The XGEO GU60 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 GU60 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), U-arm positioner, Detector, X-ray tube, Collimator and etc.
The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria through quantitative performance metrics. This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance beyond general safety and effectiveness standards.
However, based on the information provided, here's what can be gathered regarding safety and performance testing:
Key Takeaways from the Document:
- Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to assert that the XGEO GU60 is "substantially equivalent" to predicate devices (Revolution XR/d and Diamond-5A). This means demonstrating that it is as safe and effective as commercially available devices.
- Compliance with Standards: The document states that electrical, mechanical, environmental safety, and performance testing was conducted according to various IEC and CFR standards (e.g., IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, 21CFR1020.30, 21CFR1020.31). EMC testing adhered to IEC 60601-1-2(2001).
- Non-Clinical and Clinical Testing: It mentions that "Non-clinical testing and Clinical Testing were conducted in accordance with Solid-state X-ray Imaging System Guidance. All test results were satisfied." However, no details about these tests, their methodology, or specific acceptance criteria are provided.
- Image Quality Differences with No Safety Impact: The document transparently lists differences between the XGEO GU60 and its predicate devices in aspects like detector type (phosphor), number of pixels, pixel pitch, high contrast limiting resolution, DQE, and MTF. Crucially, it asserts that these differences "affect the image quality but it has not effect on safety" and "do not have an effect on safety and efficiency compared with the predicate device." This implies that while there might be differences in image quality characteristics, they were considered within an acceptable range for safety and intended use.
Regarding the specific questions, most of the requested information is not present in this 510(k) summary:
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Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided. The summary states that "All test results were satisfied" for various standards, but it does not specify the quantitative acceptance criteria for device performance (e.g., specific thresholds for spatial resolution, contrast detectability, or dose) or the numerical results achieved by the XGEO GU60.
- Implied Acceptance Criteria: The implicit acceptance criterion for this 510(k) is "substantial equivalence" to the predicate devices and compliance with the safety and performance standards cited. This means the device performed within the accepted ranges defined by those standards and was deemed to not introduce new safety risks or reduce effectiveness compared to the predicates.
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Sample Size used for the Test Set and Data Provenance: Not specified in the document.
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Number of Experts used to establish the Ground Truth for the Test Set and Qualifications: Not specified in the document. The mention of "Clinical Testing" implies human involvement, but no details are given.
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Adjudication Method for the Test Set: Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or implied. The focus is on the device itself and its equivalence, not on human reader performance with or without AI assistance.
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Standalone Performance Study: The document implicitly discusses standalone performance through its comparison of technical specifications (DQE, MTF, resolution) with predicate devices and its statement that "all test results were satisfied" for non-clinical and clinical testing. However, a dedicated study specifically labeled as "standalone" with detailed metrics is not described. The document largely speaks to the inherent capabilities of the device in comparison to its predicates.
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Type of Ground Truth Used: Not specified. For an X-ray imaging system, ground truth for image quality often involves phantom studies (non-clinical) and potentially clinical image review against established diagnostic criteria or other imaging modalities (clinical). The document only broadly mentions "Non-clinical testing and Clinical Testing."
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Sample Size for the Training Set: Not applicable as this document describes a traditional X-ray imaging system, not an AI/machine learning device that would require a "training set."
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How the Ground Truth for the Training Set was Established: Not applicable (see point 8).
In conclusion, this 510(k) summary primarily focuses on regulatory compliance and demonstrating substantial equivalence through adherence to recognized standards and a component-level comparison to predicate devices, rather than providing detailed quantitative performance studies with specific acceptance criteria and outcome metrics that would be expected for an AI-powered device or a more novel technology.
§ 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.