(28 days)
The B6 is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes:real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.
The B6 permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.
The B6 is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components.
| Control Unit Major Component | Qty. |
|---|---|
| Viewing monitor | 2 |
| Control monitor | 1 |
| Keyboard | 1 |
| Footswitch (3- or 2- pedal) | 1 |
| Printer(optional) | 1 |
| G-Arm Major Component | Qty. |
|---|---|
| Image intensifier assembly | 2 |
| X-Ray tube assembly | 2 |
| Laser light indicator | 2 |
The G-Arm system offers a group of motor-driven positioning features, including:
- lmage Intensifier Adjustment: 300 mm±10mm
- G-Arm Height Adjustment: 300 mm±10mm
- G-Arm Orbital Rotation: +35°+2°
- G-Arm Radial Rotation: ±45°±2°
The B6 can be operated in two different modes: Continuous fluoroscopy and Pulse fluoroscopy. Each of these two modes can be operated either manually or automatically.
So, the fluoroscopy mode can be categorized by the X-ray emitting pattern or by the control method of the imaging process, which consequently divides a fluoroscopy mode into the following four major types: Automatic Continuous Fluoroscopy, Automatic Pulse Fluoroscopy, Manual Pulse Fluoroscopy, Manual Continuous Fluoroscopy.
Besides the above four fundamental fluoroscopy modes, the G-Arm system offers two other features: ER Fluoroscopy and Half Dose Fluoroscopy (modifies only Automatic Pulse Fluoroscopy and Automatic Continuous Fluoroscopy modes)
The document describes a 510(k) premarket notification for the B6 mobile digital X-ray diagnostic system. The focus of the substantiation is on the device's technical characteristics and compliance with recognized standards, rather than clinical performance metrics typically associated with AI-driven diagnostic devices. Therefore, many of the requested categories related to clinical study design, ground truth, and reader performance are not directly applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily compliance with international and national safety and performance standards for medical electrical equipment and X-ray systems. The device's performance is reported as "Pass" for all tested items against these standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI/ANSI ES60601-1 | Pass (34 specific items tested, e.g., Power input, Leakage currents, Dielectric strength, Mechanical strength test) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Pass (8 specific items tested, e.g., Mains terminal continuous disturbance voltage, Radiated emission, Electrostatic discharge) |
| Radiation Protection in Diagnostic X-ray Equipment | IEC 60601-1-3 | Pass (4 specific items tested, e.g., Half-value layer, Leakage radiation in the loading state) |
| Specific Requirements for X-ray Equipment for Radiography and Radioscopy | IEC 60601-2-54 | Pass (4 specific items tested, e.g., Test for dosimetric information, Accuracy of X-ray tube voltage) |
| Digital Imaging and Communications in Medicine (DICOM) | DICOM provisions | Meets DICOM provisions |
| Software Functionality and Validation | Internal software testing | Pass (18 specific items tested, e.g., Function of Main Control Panel Software, Function of image process, CAN bus communication) |
| Substantial Equivalence | Demonstrates safety and effectiveness comparable to predicate device | Concluded to be substantially equivalent based on non-clinical testing |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical testing and verification, not a clinical study involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" in the context of patient data do not apply. The testing involved the device (B6) itself as the "sample" for verification against technical standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of technical performance and safety validation. The "ground truth" here is the adherence to established technical standards and specifications. The document implies that qualified engineers and technicians performed the tests, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study requiring adjudication of diagnostic outcomes. The "adjudication" in this context would be the determination of "Pass" or "Fail" against the specified technical test procedures and criteria by the testing personnel/organization.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the technical safety and performance of the X-ray system itself, not on the diagnostic effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an X-ray imaging device, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in the typical sense. The device's performance stands alone in its ability to meet the technical standards for image generation and system functionality.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is the established international and national technical standards for medical electrical equipment and X-ray systems (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54) and the device's design specifications. "Pathology" or "outcomes data" are not relevant here.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-driven device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.