(20 days)
The Wireless/Wired 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.
InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model F14C, F14G are portable digital detector system. 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 F14C, F14G support both wireless and wired/tethered data communication between the detector and the system. 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, roundededge 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 by using DROC(Digital Radiography Operating Console). 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
This document describes the premarket notification for the "Yushan X-Ray Flat Panel Detector with DROC," models F14C and F14G. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K201528).
Acceptance Criteria and Device Performance:
The document focuses on non-clinical performance data to demonstrate substantial equivalence. It does not provide a table of acceptance criteria with specific numerical targets for particular metrics (e.g., sensitivity, specificity, or specific image quality metrics like DQE or MTF at certain conditions) and corresponding reported performance values for a clinical study with a human-in-the-loop component or standalone AI performance.
Instead, the performance data presented primarily confirms adherence to voluntary standards and established guidance documents for X-ray imaging devices. The comparison table (pages 6-7) outlines technical specifications of the new device and the predicate.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a "table of acceptance criteria" with numerical performance targets for an AI algorithm's diagnostic performance. The context is a 510(k) submission for an X-ray flat panel detector, not an AI diagnostic software. Therefore, the "acceptance criteria" discussed are related to the hardware's technical specifications and compliance with established standards, and the "reported device performance" are measurements of these technical specifications and confirmations of compliance.
| Technical Characteristic | Acceptance Criterion (Predicate Device K201528) | Reported Performance (New Device F14C, F14G) |
|---|---|---|
| Scintillator | V14G: GOS, V14C: CsI, V17G: GOS, V17C: CsI, V17Ge: GOS | F14G: GOS, F14C: CsI |
| Pixel Pitch | 140 µm | 140 µm |
| DQE (at 1 lp/mm, RQA5) | GOS: 0.27, CsI: 0.48 | GOS: 0.27, CsI: 0.50 |
| MTF (at 1 lp/mm, RQA5) | GOS: 0.52, CsI: 0.69 | GOS: 0.52, CsI: 0.63 |
| Max. Resolution | GOS: 3.57 lp/mm, CsI: 3.57 lp/mm | GOS: 3.57 lp/mm, CsI: 3.57 lp/mm |
| A/D Conversion | 16 bit | 16 bit |
| Dimensions (WxLxH) | V14G/V14C: 460x383x15mm, V17G/V17C/V17Ge: 460x460x15mm | F14G/F14C: 460x383x15mm |
| Weight | V14G/V14C: 2.7 Kg, V17G/V17C/V17Ge: 3.2-3.5 Kg | F14G: 2.3 Kg, F14C: 2.5 Kg |
| Substrate | Glass | Non-Glass (polyethylene terephthalate laminate) |
| Interface | Wired: Gigabit Ethernet, Wireless: IEEE802.11 ac/a/g/n | Wired: Gigabit Ethernet, Wireless: IEEE802.11 ac/a/g/n |
| Biocompatibility | All material contact with patients in accordance with ISO 10993. | All material contact with patients in accordance with ISO 10993. |
| EMC | Compliance with IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489-17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017 | Demonstrated compliance through testing. |
| Load-bearing & Ingress Protection | Tested and passed | Tested and passed. |
Key finding for substantial equivalence: "Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device." (Page 10)
2. Sample Size for the Test Set and Data Provenance:
The document states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." (Page 10)
Therefore, there is no "test set" in the context of clinical image data for evaluating AI or human reader performance. The "testing" referred to is for the physical and electrical characteristics of the device. The data provenance is non-clinical, likely laboratory measurements conducted by the manufacturer, InnoCare Optoelectronics Corp. in Tainan City, Taiwan (R.O.C.).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical study or test set for diagnostic performance (such as for an AI algorithm) was used.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical study or test set for diagnostic performance was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. The device is an X-ray detector, not an AI-powered diagnostic tool requiring this type of clinical evaluation. The submission relies on non-clinical data to demonstrate substantial equivalence to the predicate device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an X-ray detector, a hardware component for acquiring images, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is established through objective measurements of technical specifications (e.g., DQE, MTF, pixel pitch), and compliance with recognized industry standards (IEC, ISO, FCC, etc.) and FDA guidance documents for medical devices. There is no biological or diagnostic ground truth (e.g., pathology, outcomes data, or expert consensus on disease presence) associated with this submission, as it relates to the performance of the image acquisition hardware.
8. The Sample Size for the Training Set:
Not applicable. The device is hardware, an X-ray detector, not an AI algorithm that requires a training set of images.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI algorithm.
§ 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.