(125 days)
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, tomography, and angiography applications.
InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V14C, V14G, V17C, V17G are portable digital detector system, while V17Ge is a non-protable digital detector. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model V14C, V14G, V17C, V17G support both wireless and wired/tethered data communication between the detector and the system, while model V17Ge is only applicable for wired use. 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. Every model have memory exposure mode, and extended image readout feature. 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.
The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (CsI)).
The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
Yushan series is working due to the combination of SDK(software development kit) and DROC(Digital Radiography Operating Console).
The SDK provides the interface for DROC to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the DROC will take the image data from SDK for further image process and display.
The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:
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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 provided text describes the Yushan X-Ray Flat Panel Detector with DROC, a device for capturing radiographic images. However, it does not include detailed acceptance criteria or a study proving its performance against such criteria in the way typically expected for an AI/CADe device.
The document is a 510(k) summary for a medical device that integrates software (DROC) for processing, annotating, and storing x-ray images, but the primary device is still a flat panel detector. The regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on specific AI performance metrics or clinical studies comparing AI-assisted vs. non-AI-assisted reads.
Here's a breakdown of the requested information based on the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (Related to image quality and features) |
|---|---|
| Image Quality: Substantial equivalence to predicate device. | Image quality evaluation confirmed equivalence to predicate. |
| Compliance with voluntary standards (e.g., 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). | Device confirms to all listed standards. |
| Compliance with FDA guidance for Solid State X-ray Imaging Devices. | Followed FDA guidance for submission of 510(k)s for Solid State X-ray Imaging Devices. |
| Wireless features testing (FCC, ETSI). | Passed FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E, FCC SAR, ETSI EN 301 489-17 V3.1.1:2017, and ETSI EN 301 489-1 V2.1.1:2017. |
| Software Level of Concern: Moderate. | Determined to be Moderate based on "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Cybersecurity risks addressed. | Cybersecurity risks addressed through device risk analysis, controls treated and implemented. |
| Load-bearing characteristics and protection against ingress of water. | Tested and passed. |
| Biocompatibility with ISO 10993 series. | Demonstrated through ISO 10993 series. |
| DQE at 1 lp/mm, RQA5 | GOS: 0.27; CsI: 0.48 |
| MTF at 1 lp/mm, RQA5 | GOS: 0.52; CsI: 0.69 |
| Max resolution | GOS: 3.57 lp/mm; CsI: 3.57 lp/mm |
| A/D Conversion | 16 bit |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned for any AI/software performance evaluation. The document states "No clinical study has been performed." The "image quality evaluation" mentioned is a non-clinical study, but details about the number of images/phantoms used are not provided.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not mentioned. The document focuses on demonstrating substantial equivalence through non-clinical performance and engineering tests, rather than a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication method for the test set
- Not applicable as there is no described clinical test set with ground truth established by experts.
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. The document explicitly states: "No clinical study has been performed." and "The substantial equivalence has been demonstrated by non-clinical studies."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies that an "image quality evaluation" was performed for the device's output. While the DROC includes processing software, the submission appears to treat it as an integral part of the flat panel detector system rather than a separate AI algorithm with standalone performance metrics. No specific standalone algorithm performance (e.g., sensitivity, specificity for a specific condition) is provided or discussed, as the device's primary function is to capture and display radiographic images, not to automatically interpret them or provide diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical image quality evaluation, the ground truth would likely be based on established physical phantoms and objective measurements (e.g., DQE, MTF under controlled conditions) rather than expert consensus on clinical findings, pathology, or outcomes data, as no clinical study was performed.
8. The sample size for the training set
- Not applicable / Not mentioned. The device is a flat panel detector system. While it has software (DROC) for image processing and display, the document does not describe it as an AI/CADe device that performs automated diagnostic interpretations requiring a training set in the conventional sense. The "processing software" mentioned is for general image display and manipulation, not for machine learning-based diagnostic assistance.
9. How the ground truth for the training set was established
- Not applicable / Not mentioned. (See point 8).
§ 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.