(80 days)
The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
The subject device Yushan X-Ray Flat Panel Detector, model V14C, V14G, V17C, V17G, F14C, F14G are portable(wireless/wired) detectors, while V17Ce, V17Ge are a non-portable(wired) detector. The Yushan X-Ray Flat Panel Detector is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
Yushan series is working by using Xresta and DR console.
The Xresta is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function includes:
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- Detector status update
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- Xray exposure workflow
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- Image viewer and measurement.
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- Post image process and DICOM file I/O
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- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
The DR Console is a software/app-based device, which is a software itself. When this app is operating the OTS can be considered as the iOS system (iOS 16 or above), the safety and effectiveness of this OTS has been assessed and evaluated through the software testing (compatibility) action and also the usability test (summative evaluation). All the functions operate normally and successfully under this OTS framework.
The function includes:
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- Imaging procedure review
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- Worklist settings
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- Detector connection settings
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- Calibration
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- Image processing
The provided document is a 510(k) summary for the Yushan X-Ray Flat Panel Detector. It outlines the device's technical characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study that proves the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for a particular condition).
Instead, the document focuses on non-clinical performance data to demonstrate substantial equivalence, primarily by showing that the device adheres to recognized voluntary standards and exhibits comparable physical and image quality characteristics to previously cleared devices.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for diagnostic performance (e.g., a specific sensitivity or specificity target for a clinical task) and the device's performance against those criteria. It focuses on technical specifications and compliance with standards.
The closest to "acceptance criteria" are the technical specifications listed for the subject device and the predicate devices, implying that meeting or being comparable to these specifications is considered acceptable for substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | "The Wireless (V14C, V14G, V17C, V17G)/Wired (V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications." (Similar for all predicates) | "The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications." |
| Pixel Pitch | 140 μm | 140 μm |
| DQE (at 1 lp/mm, RQA5) | GOS: 0.27, CsI: 0.48 (predicate K201528) / GOS: 0.27, CsI: 0.50 (predicate K210988) / CsI: 0.48 (predicate K220510) | V series: GOS: 0.27, CsI: 0.48; F series: GOS: 0.27, CsI: 0.50 |
| MTF (at 1 lp/mm, RQA5) | GOS: 0.52, CsI: 0.69 (predicate K201528) / GOS: 0.52, CsI: 0.63 (predicate K210988) / CsI: 0.69 (predicate K220510) | CsI: 0.64 (V series); GOS: 0.52, CsI: 0.63 (F series) |
| Max. Resolution | 3.57 lp/mm (for both GOS and CsI in predicates) | 3.57 lp/mm (for both GOS and CsI in subject device) |
| A/D Conversion | 16 bit | 16 bit |
| Biological Safety | All material contact with patients are in accordance with ISO 10993. | All material contact with patients are in accordance with ISO 10993. |
| EMC Emission | Satisfactory results from IEC60601-1-2 testing (implied by non-clinical performance section) | Results were satisfactory as per IEC60601-1-2 testing. |
| Image Quality | Substantially equivalent to predicate device (implied by non-clinical performance section) | Confirmed to be substantially equivalent to that of the predicate device. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study. The document states: "No clinical study has been performed."
- Data Provenance: Not applicable. The evaluation relies on non-clinical (laboratory/technical) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study with expert ground truth was performed.
4. Adjudication method for the test set
Not applicable, as no clinical study with a test set requiring adjudication was performed.
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 was done. This device is an X-ray flat panel detector, not an AI software intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (X-ray detector) with associated software for image processing and display, not an AI algorithm. Its performance is inherent in its image acquisition capabilities. The "standalone" performance here refers to the detector's physical performance metrics (DQE, MTF, resolution).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the image quality evaluation mentioned: The ground truth implicitly refers to the ideal image quality parameters as defined by industry standards (e.g., IEC standards for DQE, MTF) and the performance of the legally marketed predicate devices. It is not a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a distinct training set in the typical sense. Its "training" would be the engineering and manufacturing processes to ensure it meets its design specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of an AI model for this device. The "ground truth" for the device's development would be its design requirements and engineering specifications validated through non-clinical testing.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" referenced in the document is a compilation of non-clinical performance tests and adherence to voluntary standards.
- Non-clinical Performance Data: The device conforms to voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1, and ANSI/AAMI HE75.
- FDA Guidance adherence: The "FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" (September 1, 2016) was followed to describe detector characteristics. Guidance documents for software (June 14, 2023) and cybersecurity (September 27, 2023) were also followed.
- Specific Tests Conducted:
- Risk analysis, verification, and validation activities.
- Load-bearing characteristics and protection against ingress of water (passed).
- EMC emission testing (IEC60601-1-2) – results satisfactory.
- Biocompatibility testing (ISO 10993 series) for materials in contact with patients.
- Image Quality Evaluation: Confirmed that the image quality of the Yushan X-Ray Flat Panel Detector is substantially equivalent to that of the predicate device. This is the key "performance" study, demonstrating that the new device's images are comparable to those produced by already-cleared devices, implying acceptable clinical usability for its stated indications.
Conclusion stated in the document: Based on these non-clinical studies and comparisons, the manufacturer concluded that the device is "as safe and effective" as the legally marketed predicate devices and does not raise "different questions of safety and effectiveness."
§ 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.