(51 days)
The Wired 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.
InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V17Ce is a nonprotable(wired) 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. 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. V17Ce 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 the scintillator material is cesium iodide (Csl). 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 x-ray generator (an integral part of a complete x-ray system), is not part of the submission. 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, The personal computer is not part of this submission. 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: 1. Detector status update 2. Xray exposure workflow 3. Image viewer and measurement. 4. Post image process and DICOM file I/O 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network.
This document is a 510(k) summary for the InnoCare Optoelectronics Corp.'s Yushan X-Ray Flat Panel Detector with DROC (model V17Ce). It seeks to demonstrate substantial equivalence to a predicate device (Yushan X-Ray Flat Panel Detector with DROC, model V17Ge, K201528).
Based on the provided text, the device in question is an X-ray flat panel detector, not an AI/ML medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable to this submission.
The document primarily focuses on demonstrating substantial equivalence through non-clinical performance data and technical comparisons to a predicate device.
Here's how the provided information relates to acceptance criteria and performance, as much as can be extracted for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
For an X-ray flat panel detector, acceptance criteria are typically related to technical specifications and compliance with standards. The document presents a comparison table between the new device (V17Ce) and the predicate device (V17Ge).
| Feature | Acceptance Criteria (Predicate V17Ge Performance) | Reported Device Performance (V17Ce) | Notes |
|---|---|---|---|
| Clinical Intended Use | The Wireless/Wired 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 Wired 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 intended use for the V17Ce is virtually the same as the predicate V17Ge, with the V17Ce being specifically "Wired" and including a caution for pregnant women, which is not explicitly stated for the predicate in this table but is likely a general precaution for X-ray exposure. The core application (general projection radiography) and exclusions remain identical. This indicates the V17Ce meets the acceptance criterion of having a comparable intended use. |
| Compliance Standards | - FDA Standards 21 CFR 892.1680 for stationary x-ray system |
- European Medical Devices Directive (93/42/EEC)
- EN ISO 13485
- ISO 14971
- ANSI/AAMI ES60601-1
- CAN/CSA C22.2 No. 60601-1:14
- IEC 60601-1-2
- IEC 62304
- IEC 60601-1-6
- IEC 62366-1
- ISO 10993-1
- ISO 10993-5
- ISO 10993-10
- ISO 15223-1 | - FDA Standards 21 CFR 892.1680 for stationary x-ray system
- European Medical Devices Directive (93/42/EEC)
- EN ISO 13485
- ISO 14971
- ANSI/AAMI ES60601-1
- CAN/CSA C22.2 No. 60601-1:14
- IEC 60601-1-2
- IEC 62304
- IEC 60601-1-6
- IEC 62366-1
- ISO 10993-1
- ISO 10993-5
- ISO 10993-10
- ISO 15223-1 | The V17Ce confirms to the same comprehensive set of voluntary standards as the V17Ge. This indicates the V17Ce meets the acceptance criterion of regulatory and safety compliance. |
| Dimensions (mm) | V17Ge: 460(W)×460(L)×15(H) | V17Ce: 460(W)×460(L)×15(H) | Identical dimensions. Meets acceptance criterion of physical compatibility. |
| Weight (Kg) | V17Ge: 3.5 | V17Ce: 3.6 | Slightly heavier, but this minor difference (0.1kg) is likely considered acceptable in the context of substantial equivalence for this device type. |
| Scintillator | V17Ge: GOS (Gadolinium Oxysulfide) | V17Ce: CsI (Cesium Iodide) | This is the primary difference highlighted in the document. The shift from GOS to CsI is significant for image quality. The document states that 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," implying that despite the different scintillator, the resulting image quality performance is acceptable. Specific acceptance criteria for image quality would be implied by this statement. The DQE and MTF values (below) support the performance of the CsI scintillator. |
| Pixel Pitch | 140 μm | 140 μm | Identical. Meets acceptance criterion. |
| DQE (at 1 lp/mm, RQA5) | GOS: 0.27 | CsI: 0.48 | The CsI scintillator (V17Ce) shows a significantly higher DQE (Detective Quantum Efficiency) than the GOS scintillator (V17Ge). A higher DQE indicates better X-ray signal utilization and potentially lower dose requirements for the same image quality, or better image quality at the same dose. This is an improvement that generally supports effectiveness. The acceptance criterion would be that image quality is at least equivalent or better, which this meets. |
| MTF (at 1 lp/mm, RQA5) | GOS: 0.52 | CsI: 0.69 | The CsI scintillator (V17Ce) shows a higher MTF (Modulation Transfer Function) than the GOS scintillator (V17Ge). A higher MTF indicates better spatial resolution and image sharpness. This is an improvement that generally supports effectiveness. The acceptance criterion would be that image quality is at least equivalent or better, which this meets. |
| Max. Resolution | GOS: 3.57 lp/mm | CsI: 3.57 lp/mm | Identical. Meets acceptance criterion. |
| A/D Conversion | 16 bit | 16 bit | Identical. Meets acceptance criterion. |
| Pixels | V17Ge: 3072 x 3072 | V17Ce: 3072 x 3072 | Identical. Meets acceptance criterion. |
| Interface | Wired: Gigabit Ethernet (100BASE-TX or 10BASE-T) | Wired: Gigabit Ethernet (100BASE-TX or 10BASE-T) | Identical. Meets acceptance criterion. |
| Power Source | Rechargeable Lithium Battery (Not applicable on V17Ge) | Not applicable | The V17Ce is described as a "nonportable (wired) digital detector," indicating it does not use a battery for operation. This is a distinction from the predicate (V17Ge), which could be wireless/wired and had an optional battery. For the wired V17Ce, "Not applicable" for power source aligns with its wired nature, differentiating it from the predicate's wireless capability (which leveraged a battery). This is not an acceptance criterion but a design difference explained by the "wired" nature. |
| Biological Safety | All material contact with patients are in accordance with ISO 10993. | All material contact with patients are in accordance with ISO 10993. | Identical. Meets acceptance criterion related to biocompatibility. |
| Image Quality Evaluation| Implied to be acceptable (as predicate is cleared) | Confirmed to be "substantially equivalent" to predicate device. | This is a high-level statement confirming that the overall image quality meets the necessary standard for substantial equivalence, overcoming the difference in scintillator material. Specific quantitative criteria for this "evaluation" are not detailed in this summary. |
| Mechanical Integrity | Implied to be acceptable | Load-bearing characteristics and protection against ingress of water were tested and passed. | Demonstrates robustness. Meets implied acceptance criteria for physical durability. |
| EMC Emission | Implied to be acceptable | IEC60601-1-2 testing resulted in "satisfactory" results. | Confirms electromagnetic compatibility. Meets acceptance criterion. |
| Cybersecurity Risks | Implied to be addressed | Addressed to assure no new or increased risks. Device software used unchanged from predicate. | Meets acceptance criteria for cybersecurity risk management for medical devices. |
| Software Level of Concern | Implied to be acceptable | Determined to be "moderate" based on FDA guidance; verification and validation activities performed. | Meets acceptance criterion for software safety and documentation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A) for AI/ML device.
- For this traditional X-ray detector, the performance evaluation is based on non-clinical bench testing:
- Compliance with various international standards (e.g., IEC 60601-1-2 for EMC, ISO 10993 series for biocompatibility).
- Specific technical measurements (DQE, MTF, resolution).
- Mechanical tests (load-bearing, water ingress).
- The document implies that these tests were conducted on the V17Ce device. There is no mention of "data provenance" in the sense of clinical image datasets or patient data, as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A for AI/ML device.
- For this detector, "ground truth" is established through physical measurements and adherence to engineering standards and specifications. There are no human experts "reading" images for ground truth in the context of device performance in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A for AI/ML device. Adjudication relates to resolving disagreements among human readers or experts, which is not relevant here as there are no human readers or clinical image interpretations involved in establishing device performance.
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
- N/A. This is not an AI-enabled device. No MRMC study was conducted. The evaluation is solely based on the physical and image quality characteristics of the detector itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm. Its performance is inherent to its hardware and associated processing software, which is evaluated against engineering benchmarks and standards.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not "ground truth" in the AI/ML sense. For this device, performance is evaluated against:
- Engineering specifications and measurements: DQE, MTF, resolution, pixel pitch, dimensions, etc.
- Compliance with international safety and performance standards: e.g., IEC 60601 series, ISO 10993 series, FDA regulations.
- Comparative technical characteristics to a legally marketed predicate device.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/ML device subject to machine learning model training.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth for it.
In summary: The substantial equivalence determination for the Yushan X-Ray Flat Panel Detector with DROC (V17Ce) is based on thorough non-clinical bench testing and comparison of technical specifications to a predicate device, focusing on compliance with established safety and performance standards. The primary difference (scintillator material) and its impact on image quality (improved DQE and MTF) were evaluated and deemed to result in performance that is substantially equivalent to the predicate, not raising new questions of safety or effectiveness. No clinical studies or AI/ML-specific evaluations were performed or required for this 510(k) submission.
§ 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.