(198 days)
SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
The SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications. SPINEL 12HD is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
The provided document is a 510(k) premarket notification for the SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System. It asserts substantial equivalence to a predicate device (KMC-950) rather than independently proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and clinical study details for the SPINEL 12HD is not explicitly stated in this document.
However, based on the information provided, I can infer some aspects and present what is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance results for the SPINEL 12HD itself. Instead, it argues for substantial equivalence by comparing its technical specifications and performance characteristics to a predicate device (KMC-950) and a reference device (Artis one Angiographic System for the FPD). The performance characteristics are mostly described in terms of technical specifications of components.
| Feature | Predicate Device (KMC-950) | Proposed Device (SPINEL 12HD) | Justification/Comment |
|---|---|---|---|
| X-ray tube | Varian (RAD-99) | Toshiba (E7833X) | "New X-ray tube was used for the subject device due to the aspect of cost and supply capacity of the manufacturer. Both X-ray tube have equivalent technical specification. There is no difference in the safety and effectiveness for both X-ray tubes." Risk factors considered. |
| Anode Type | Rotating | Rotating | Equivalent |
| Heat Capacity | 300,000 HU | 300,000 HU | Equivalent |
| Anode Heat Cooling | 70kHU/min | 70kHU/min | Equivalent |
| Focal size | 0.3mm / 0.6mm | 0.3mm / 0.6mm | Equivalent |
| X-ray Generator Power | 12 kW | 12 kW | Equivalent |
| Fluoroscopic kV range | 40 to 125 kV | 40 to 120 kV | "Changed X-ray control range to improve output stability and effectiveness compared to the predicate device. kV → Adjusted the kV range to be aligned with the X-ray exposure setting." |
| Fluoroscopic mA range | 0.5 to 5 mA | 0.2 to 10 mA | "mA → Adjusted and broadened the mA range for more stable X-ray exams of different human body parts." |
| Detector | Thales (TH9428HP2) Image Intensifier (9") | Pixium 2630S Flat Panel Detector (11.3 x 10.3") | "The new digital FPD of the subject device has better performance specification compared to the image intensifier of the predicate device in terms of image quality and resolution." FPD cleared under K133580. Risk factors considered. |
| Detector DQE | 65 | 70 (@ 0 lp/mm) | Improved. |
| Detector MTF | 92 (@ 2 lp/cm) | 59 (@ 1 lp/mm) | Note: Units differ (lp/cm vs lp/mm), making direct comparison difficult without conversion or further context. However, the document states generally improved performance for FPD. |
| Detector Resolution | 48 μm | 92 μm (184 μm in 2x2 binning) | The pixel size (1800x1500) of the subject device is stated to be "better than the active pixel (512x512) of the predicate device." This typically implies higher resolution in digital detectors. Note: The listed μm values represent pixel size, where a smaller number is typically better for resolution. The document's qualitative statement implies overall image quality improvement. |
| Monitor Size | 17" | 19" | "The monitor size has increased to provide better image viewing experience for the user." |
| Software functions | ABC function | IODC and MDC functions added | "Both IODC and MDC function are added to optimize (Check the type and position of the object and perform fast process speed and accurate processing.) the ABC function which is already included in the predicate." "images of before and after applying each function have been compared which validates the efficacy of both IODC and MC functions." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense (e.g., patient cases). The evaluation for this 510(k) submission primarily relies on non-clinical testing, including:
- Engineering testing
- Standards compliance testing
- Verification and Validation (V&V) activities for software (IODC and MDC functions).
Therefore, there is no patient-based test set sample size described. The data provenance would be laboratory testing environments in the Republic of Korea (where GEMSS MEDICAL SYSTEMS CO., LTD. is located). The data is generated from prospective non-clinical testing designed to verify compliance with standards and functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical test set with patient data was used, no experts were used to establish ground truth in the context of clinical interpretation for this submission. The "ground truth" for the non-clinical tests would have been established by engineering specifications, calibration standards, and recognized international standards (e.g., IEC, NEMA).
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described in this 510(k) submission. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with safety standards, not on clinical comparative effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an X-ray imaging system, not an AI algorithm for image analysis. The "Intelligent Object Dose Control (IODC)" and "Metal Detected Control (MDC)" are described as software functions to optimize X-ray exposure, not to perform standalone diagnostic interpretation.
The V&V Report for IODC and MDC "contains the software quality and performance testing activities" and "The images of before and after applying each function have been compared which validates the efficacy of both IODC and MC functions." This implies some form of standalone performance evaluation for these specific software features in a technical context, showing they correctly adjust image brightness. However, it's not a diagnostic "algorithm only" study as one might see for an AI CADx device.
7. Type of Ground Truth Used
For the non-clinical testing and software V&V, the ground truth would be based on:
- Engineering specifications: Device performance parameters against designed specifications.
- Physical measurements and phantoms: For radiation output, image quality metrics (DQE, MTF), and resolution.
- Standard compliance: Adherence to recognized national and international safety and performance standards (e.g., IEC 60601 series, NEMA PS 3.1-3.20, ISO 14971, 21 CFR regulations).
- Comparison to predicate device's established performance.
8. Sample Size for the Training Set
Not applicable. This device is a medical imaging hardware system with integrated software, not a machine learning or AI model trained on a dataset of cases. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.