(29 days)
The ANY VIEW DR SERIES (Anyviw-500DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.
This system can be applied in emergency room, operation room, cast room or etc. of hospital.
The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) are mobile x-ray fluoroscopic imaging systems used by radiation experts. ANYVIEW DR SERIES are a digital fluoroscopic imaging systems with Flat Panel Detector (FPD) used in diagnostic and interventional procedures. ANYVIEW DR SERIES are composed of C-arm, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motor-type collimator), FPD, and workstation (console computer and monitor).
ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, ANYVIEW FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System.
ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm imaqes taken during an exam are stored in the database for further review. I Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system.
The ECOTRON Co., Ltd. ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm (ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR) is a radiation medical equipment designed to provide fluoroscopic and spot film images for diagnostic and interventional procedures. The device was found to be substantially equivalent to its predicate device, Anyview-500R Fluoroscopic Mobile X-ray System (K160279), based on non-clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state formal "acceptance criteria" in a go/no-go format for performance metrics. Instead, it presents a comparison of technical characteristics and performance data of the subject device against its predicate and reference devices, demonstrating equivalent or improved performance without raising new safety or effectiveness concerns.
| Characteristic | Acceptance Criteria (Implied by Predicate/Reference) | Subject Device Performance (ANYVIEW DR SERIES) | Predicate Device Performance (Anyview-500R, K160279) | Reference Device Performance (D2RS AT, K150306) |
|---|---|---|---|---|
| Intended Use | Fluoroscopic and spot film images for diagnostic and interventional procedures. | Same | Same | N/A (Reference device details less explicit for this) |
| Energy Source | 220V~230V, Single 50/60 Hz | Same | Same | N/A |
| X-ray Generator Type | HFG INVERTER TYPE | Similar (HFG INVERTER TYPE) | HFG INVERTER TYPE | N/A |
| Fluoroscopy Continuous Mode | 0.5-10mA | Same | Same | N/A |
| Fluoroscopy Pulsed Mode | 0.5-20mA | Same | Same | N/A |
| Fluoroscopy Boost Mode | 30mA | Same | Same | N/A |
| Radiography kV Range | 40-125 kV | Similar (40-125 kV depending on model) | 40-125 kV | N/A |
| Radiography mA Range | 20-100 mA | Similar (15-100 mA depending on model) | 20-100 mA | N/A |
| Radiography mAs Range | 0.8-200 mAs | Similar (0.8-200 mAs depending on model) | 0.8-200 mAs | N/A |
| X-ray Tube Type | TOSHIBA XR-2551 | TOSHIBA XRR-2251 (Same) | TOSHIBA XR-2551 | N/A |
| Detector Type | Image Intensifier (Predicate) / Flat Panel Detector (Reference) | Flat Panel: TFT: a-Si w/ | ||
| CsI: TI scintillator | Imaging Intensifier: E5830SD-P4A | Pixium RF 4343 (FPD) | ||
| Detector Input FOV | 9 inch (Predicate) | 12 x 12 in | 9 inch | 17x17 in |
| Detector Central Resolution | 54/62/70 lp/cm (Predicate) | 3.4 lp/mm | 54/62/70 lp/cm (for 9/6/4.5 inch modes) | 3.4 lp/mm |
| Detector MTF (1 lp/mm) | N/A (Predicate, different detector type) | 54% (VS VIeworks), 60% (VS Thalaes) | N/A | 62% |
| Detector DQE (1 lp/mm) | 65% (Predicate) | 69% (VS VIeworks), 69% (VS Thalaes) | 65% | 52% |
| Detector Spatial Resolution | 5.2 lp/mm (Predicate) | 3.4 lp/mm | 5.2 lp/mm (min) | 3.4 lp/mm |
| Pixel Size/Output Resolution | 1K x 1K (Predicate - implied) | 2K x 2K | 1K x 1K (implied from 12bit grayscale) | N/A (implied by 2874x2840 pixels) |
| Electrical Safety Standards | IEC 60601-1, -1-2, -1-3, -2-28, -2-43, -2-54 | Meets all listed IEC standards | Meets all listed IEC standards | N/A |
| EPRC Performance Standard | 21 CFR 1020.30/1020.32 | Meets 21CFR 1020.30/1020.32 | Meets 21CFR 1020.30/1020.32 | N/A |
2. Sample size used for the test set and the data provenance:
- Test Set: The study primarily relies on bench testing and comparative performance data of components (specifically the Flat Panel Detector, FPD) for non-clinical evaluation. There is no mention of a traditional "test set" of patient images.
- Data Provenance: The data provenance for the performance characteristics (MTF, DQE, Spatial Resolution) of the detectors is from the respective manufacturers (VIEWORKS for Subject Device, TOSHIBA for Predicate Device, and Thales for Reference Device). This is non-clinical, technical performance data. The document does not specify country of origin for this component-level data, nor whether it is retrospective or prospective, though it is typically collected during product development/testing by the manufacturer.
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):
Not applicable. The study is a 510(k) submission for substantial equivalence based on technical and performance characteristics of medical hardware, not on clinical image interpretation or diagnostic accuracy by experts. No ground truth was established by human experts for a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set requiring expert adjudication was used.
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. The device described is an X-ray imaging system, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is an imaging system, not an algorithm, and its performance evaluation does not involve standalone algorithm assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The equivalence is established through engineering and technical performance comparisons of the device and its key components against predicate and reference devices, not against clinical ground truth. Performance metrics like MTF, DQE, and spatial resolution are derived from physical measurements and scientific testing of the imaging system and its components.
8. The sample size for the training set:
Not applicable. This is a medical device for imaging acquisition, not a machine learning or AI algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.