(141 days)
The CareView 3600RF 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-purposic procedures. This product is not intended for mammography applications.
The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).
The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.
The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device.
The information provided indicates that the CareRay Digital Medical Technology Co., Ltd. CareView 3600RF X-ray Flat Panel Detector is seeking market clearance through a 510(k) submission, asserting substantial equivalence to the iRay Technology (Shanghai) Ltd. Mars1417V-PSI Wireless Digital Flat Panel Detector (K161730). Since this is a 510(k) submission for a traditional medical device (X-ray Flat Panel Detector) and not a software-as-a-medical-device (SaMD) or AI/ML-driven device with clinical performance endpoints based on diagnostic accuracy, the acceptance criteria and study detailed primarily focus on technical performance metrics rather than clinical efficacy involving human readers or AI algorithms.
Here's a breakdown of the available information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
For an X-ray Flat Panel Detector, the "acceptance criteria" and "reported device performance" are typically defined by various technical specifications and physical performance metrics, often compared against a predicate device and industry standards. The submission highlights several of these:
| Performance Metric | Acceptance Criteria (Predicate Device K161730) | Reported Device Performance (CareView 3600RF) |
|---|---|---|
| X-ray Absorber | GOS Scintillator | GOS Scintillator |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2800 pixels | 5632 x 2816 pixels |
| Pixel Pitch | 150 µm | 154 µm |
| Effective Imaging Area | 355 mm x 434 mm | 867.5 mm x 433.1 mm |
| Grayscale | 14 bit | 16 bit |
| Spatial Resolution | 3.4 lp/mm | 3.4 lp/mm |
| MTF (@ 0.5 lp/mm) | 0.75 (75%) | 75% |
| MTF (@ 1 lp/mm) | (Not specified explicitly, but generally expected to be comparable based on spatial resolution) | 50% |
| DQE (@ RQA5, 3.2 µGy, 0.5 lp/mm) | 0.27 (27%) | 28% |
| DQE (@ RQA5, 3.2 µGy, 1 lp/mm) | (Not specified explicitly) | 20% |
| Communications | Wired: Gigabit Ethernet, Wireless: IEEE 802.11a/b/g/n (2.4 GHz/ 5 Glz) | Gigabit Ethernet (Wired only) |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Operation Temperature | +5 ~ +35°C | +10 ~ +40°C |
| Operation Humidity | 30 ~ 75% RH (Non-Condensing) | 30 ~ 75% RH (Non-Condensing) |
| Operation Atmospheric Pressure | 700 ~ 1060 hPa | 700 ~ 1060 hPa |
| Operation Altitude | Max. 3000 meters | Max. 3000 meters |
| Storage/Transport Temperature | -20 ~ +55°C | -20 ~ +55°C |
| Storage/Transport Humidity | 10 ~ 90% RH (Non-Condensing) | 10 ~ 90% RH (Non-Condensing) |
| Storage/Transport Atmospheric Pressure | 700 ~ 1060 hPa | 700 ~ 1060 hPa |
| Storage/Transport Altitude | (Not specified explicitly for predicate) | Max. 3000 meters |
| Electrical Safety & EMC | Compliance with IEC/ES 60601-1, IEC/EN 60601-1-2 | All test results satisfactory |
The acceptance criteria here are implicitly drawn from the predicate device's characteristics and the relevant performance standards for X-ray detectors. The "reported device performance" are the measurements taken from the CareView 3600RF. The statement "All test results are satisfactory" for electrical safety and EMC indicates compliance with relevant standards as the acceptance criteria.
2. Sample size used for the test set and the data provenance
The document describes non-clinical studies that evaluated the device's technical performance. These studies typically use physical phantoms or test objects rather than patient data. Therefore, the concept of "sample size" in terms of patient images or clinical cases, and "data provenance" (country of origin, retrospective/prospective) as it applies to clinical studies, is not directly applicable here. The "test set" would consist of various physical measurements performed on the detector itself, following standardized protocols (e.g., those for DQE, MTF, NPS).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is based on technical, physical performance characteristics of the X-ray detector (e.g., DQE, MTF), not on diagnostic interpretation of medical images by human experts. The "ground truth" for these technical metrics is established by physical measurement methods and calibrated equipment, compared against defined industry standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert disagreement on ground truth needs resolution.
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
There is no indication that an MRMC comparative effectiveness study was performed. This submission is for an X-ray Flat Panel Detector, which is a hardware component for image acquisition, not an AI-driven image analysis or diagnostic assistance software. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no indication of a standalone algorithm performance study. The device is a hardware detector, and the software mentioned (CareRay software, APIs) is for controlling the detector and transferring images, not for independent diagnostic interpretation or AI-driven analysis.
7. The type of ground truth used
For the non-clinical studies mentioned (Detective quantum efficiency (DQE), Modulation transfer function (MTF), Noise power spectrum (NPS), Spatial resolution, etc.), the "ground truth" is based on objective physical measurements and standardized phantom evaluations. These measurements assess the intrinsic performance characteristics of the detector itself, following recognized international and national standards for medical imaging devices.
8. The sample size for the training set
This information is not applicable. The CareView 3600RF is an X-ray Flat Panel Detector, a hardware device. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as 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.