(168 days)
Mars1417V-PSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.
Mars1417V-PS1 Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 36cm×43cm.
The sensor plate of Mars1417V-PSI Wireless Digital Flat Panel Detector is direct-deposited with Gd2O2S scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.
The major function of the Mars1417V-PSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical Xray imaging with the DR system software.
The iRay DR used for getting Digital X -ray radiography images from the flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0), iRay DR is responsible for the DR equipment management, acquisition and processing functions, to provide patient registration, scanning, image processing and forwarding, and other functions ..
The provided document is a 510(k) Summary for the iRay Technology (Shanghai) Ltd. Wireless Digital Flat Panel Detector (Mars1417V-PSI), which is a digital X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study for the device's clinical performance.
However, based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence by comparing technological characteristics and an absence of significant difference in clinical images compared to a predicate device (ViZion DR+Wireless, K152279).
Based on the Nonclinical Considerations section, the performance characteristics evaluated are:
| Acceptance Criteria (Implicit from Nonclinical Studies) | Reported Device Performance (Mars1417V-PSI vs. Predicate) |
|---|---|
| Detective Quantum Efficiency (DQE) | 0.27 at 0.5 lp/mm (RQA5, 3.2µGy) - Matches predicate |
| Quantum limited performance | Not explicitly quantified, implied to be equivalent to predicate |
| Modulation Transfer Function (MTF) | 0.75 at 0.5 lp/mm - Matches predicate |
| Effects of aliasing | Not explicitly quantified, implied to be equivalent to predicate |
| Sensitivity linearity | Not explicitly quantified, implied to be equivalent to predicate |
| Lag | Not explicitly quantified, implied to be equivalent to predicate |
| Change in detection sensitivity | Not explicitly quantified, implied to be equivalent to predicate |
| Dose requirement and reciprocity changes | Not explicitly quantified, implied to be equivalent to predicate |
| Stability of device characteristics with time | Not explicitly quantified, implied to be equivalent to predicate |
| Uniformity of device characteristic | Not explicitly quantified, implied to be equivalent to predicate |
| Noise power spectrum (NPS) | Not explicitly quantified, implied to be equivalent to predicate |
| Spatial resolution | Min. 3.4lp/mm - Matches predicate |
| Image Acquisition time | Not explicitly quantified, implied to be equivalent to predicate |
| Black level | Not explicitly quantified, implied to be equivalent to predicate |
| Software functionality (iRayDR) | Passes 83 test cases, complies with intended design specification |
| Electrical Safety, EMC, Biological Evaluation | Meets standard requirements (IEC/ES 60601-1, IEC/EN 60601-1-2, ISO 10993-1) |
| Clinical Image Comparison | No significant difference between images of Mars1417V-PSI and predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Image Comparison: 30 clinical images.
- Data Provenance: The document does not specify the country of origin for the clinical images, nor does it explicitly state if the study was retrospective or prospective. Given the context of a 510(k) submission for substantial equivalence based on a comparison, it's highly likely these were retrospective images or images specifically acquired for comparison purposes but not necessarily part of a broader prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "A concurrence study of 30 clinical images was conducted to compare the performance of the Mars1417V-PSI to that of the predicate device (ViZion DR+Wireless,K152279)."
It does not specify the number of experts used or their qualifications for evaluating these 30 clinical images. It only mentions that "no significant difference" was found.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical image comparison, nor does it detail how the "no significant difference" conclusion was reached.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described is a comparison of the device's images to those of a predicate device, not an evaluation of AI assistance for human readers.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was performed in terms of non-clinical tests evaluating physical characteristics like DQE, MTF, spatial resolution, and others. The software (iRayDR) also underwent standalone testing with 83 test cases. The clinical image comparison, while assessing image quality, doesn't constitute a standalone algorithm performance in the context of an AI device, as this is a digital flat panel detector, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
For the 30 clinical images used in the comparison study, the "ground truth" implicitly referred to the diagnostic quality of the images produced by the predicate device. The study aimed to show "no significant difference" in image quality between the proposed device and the predicate device, implying that the diagnostic utility of the predicate's images served as the reference. There is no mention of pathology or outcomes data as ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This device is a digital flat panel detector, which converts X-rays into digital images, and the software mentioned (iRayDR) handles image processing and DICOM protocols. This is not an AI diagnostic algorithm that requires a specific training set to learn to identify pathology.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an AI diagnostic algorithm, this question is not applicable. The software components described appear to be for image acquisition, processing, and management, not for automated diagnosis based on
learned patterns.
§ 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.