(27 days)
Mercu1717V Digital Flat Panel Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging. The sensor plate of Mercu1717V is direct-deposited with CsI 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 cable. The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
The provided document does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the context of clinical performance or human reader studies. Instead, it focuses on the device's technical specifications and substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis based on the available information, noting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance (Based on provided technical specifications for comparison with predicate devices):
The document primarily compares various technical specifications of the Mercu1717V with its predicate and reference devices, aiming to demonstrate substantial equivalence rather than explicit acceptance criteria and performance against those criteria as would be typical for clinical effectiveness. However, we can extract some performance metrics from the comparison table.
| Characteristic | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Mercu1717V) |
|---|---|---|
| Image Matrix Size | Predicate: 3072x3072 pixels | |
| Reference: 5632x2816 pixels | Min. 1024x1024 pixels (@binning 3x3) | |
| Max. 3072x3072 pixels (@binning 1x1) | ||
| Pixel Size | Predicate: 139μm | |
| Reference: 154μm | 139μm | |
| Effective Imaging Area | Predicate: 427mmx427mm | |
| Reference: 867.5mm x 433.1mm | Min. 285mmx285mm (@zoom on) | |
| Max. 427mm x 427mm (@zoom off) | ||
| Spatial Resolution | Predicate: Min. 3.4 lp/mm | |
| Reference: Same as Predicate | Min. 3.4 lp/mm (Same as Predicate) | |
| MTF (Modulation Transfer Function) | Predicate: 0.66 at 1 lp/mm | |
| Reference: 0.75 at 0.5lp/mm, 0.5 at 1lp/mm | 0.78 at 0.5lp/mm, 0.55 at 1lp/mm (Better than both at 0.5lp/mm, better than predicate at 1lp/mm) | |
| DQE (Detective Quantum Efficiency) | Predicate: 0.28 at 1 lp/mm (RQA5, 2.5µGy) | |
| Reference: 0.28 at 0.5 lp/mm, 0.20 at 1 lp/mm (RQA5, 3.2µGy) | 0.4 at 0.5 lp/mm, 0.35 at 1 lp/mm (RQA5, 2.5µGy) (Better than both) | |
| Frame Rate (Dynamic Imaging) | Predicate: / | |
| Reference: 3.5fps@1x1, 15fps@2x2, 25fps@4x4 | 5fps@1x1, 20fps@2x2, 30fps@3x3 (Generally better) | |
| Electrical Safety & EMC | Standards: IEC/ES 60601-1, IEC 60601-1-2 | All test results meet standard requirements. |
Missing Information:
The document does not explicitly state acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it demonstrates an equivalence to predicate devices through technical specifications and compliance with safety standards. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed to show substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of clinical images or patient data tests for this submission. The "test set" here refers to the actual device undergoing non-clinical technical evaluations (e.g., electrical safety, EMC, image quality parameters like MTF, DQE).
- Data Provenance: Not applicable. The evaluations are technical measurements of the physical device under specific lab conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a digital flat panel detector, a hardware component for acquiring X-ray images. The submission focuses on its physical characteristics, safety, and image quality parameters, not on the interpretation of images by experts. Ground truth in this context would relate to the objective measurement of physical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication of diagnostic outcomes is mentioned or implied, as this is a device component clearance and not a diagnostic AI software submission.
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 as this submission pertains to a digital X-ray detector, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done for diagnostic purposes. The device is a hardware component. Its "standalone" performance relates to its physical performance metrics (e.g., DQE, MTF) as measured in a lab setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical studies (e.g., MTF, DQE, electrical safety), the "ground truth" would be established by standardized measurement protocols and reference instruments, as per relevant IEC or other industry standards. It's objective, physical measurements rather than clinical ground truth from patient data.
8. The sample size for the training set:
- Not applicable. This document is for a hardware device (digital flat panel detector) and its associated software (iRayDR), which is described as image acquisition, processing, and archiving software, not a machine learning model that requires a training set of medical images.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a machine learning model or a training set. The software mentioned (iRayDR) performs image acquisition and post-processing, typical for a radiological workstation, not AI-driven diagnosis.
§ 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.