(246 days)
The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
The Cios Alpha is a mobile fluoroscopy system designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and moved forward/backward by an operator.
b) The monitor trolley providing image processing, review and patient data entry. The monitor trolley may contain an optional hardcopy (paper) printer and navigational equipment as well.
The Siemens Cios Alpha is a mobile fluoroscopic X-ray system that undergone non-clinical and clinical testing to demonstrate its performance and substantial equivalence to a predicate device, the ARCADIS Avantic.
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantitative acceptance criteria for image quality beyond general "Good" or "Very good" ratings. However, it does compare technological characteristics.
| Feature | Subject Device (Cios Alpha) | Predicate Device (ARCADIS Avantic) | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Cios Alpha) |
|---|---|---|---|---|
| Image Quality (Clinical Evaluation) | At least comparable to predicate | Described as "even better, more detailed image quality as compared to the ARCADIS Avantic" for various procedures. | ||
| Spatial Resolution (Clinical Evaluation) | At least comparable to predicate | "Good" to "Very good" | ||
| Motion Resolution (Clinical Evaluation) | At least comparable to predicate | "n.a." (for Carotids and peripheral vascular), "Very good" (for EVAR procedures) | ||
| Contrast (Clinical Evaluation) | At least comparable to predicate | "Acceptable" to "Good" | ||
| Noise (Clinical Evaluation) | At least comparable to predicate | "Low" to "Acceptable" | ||
| Mobile Fluoroscopy C-arm | Yes | Yes | Yes | Yes |
| Tube housing assembly with high frequency generator | Yes | Yes | Yes | Yes |
| kV range | 40 kV - 125 kV | 40 kV - 125 kV | 40 kV - 125 kV | 40 kV - 125 kV |
| Max power output | 12 kW, 25 kW (optional) | 20 kW | At least 20 kW | 12 kW, 25 kW (optional) (an improvement) |
| Pulsed Fluoroscopy (mA) | 3 mA to 120 mA (12kW), 3 mA to 250 mA (25kW) | Up to 70 mA | At least up to 70 mA | Higher (an improvement) |
| X-ray detector | Solid State Detector (20cm x 20cm or 30cm x 30cm) | Image Intensifier (13" diameter) | Not explicitly defined, but solid state detector is a technological advancement | Solid State Detector |
| Dose measurement device | Yes | Yes | Yes | Yes |
| Matrix size | 1536 x 1536 | 1024 x 1024 | At least 1024 x 1024 | 1536 x 1536 (an improvement) |
| Monitors | 19" TFT Flat Screen Display Panels, B/W or Color | 18" TFT Flat Screen Display Panels, B/W or Color | At least 18" | 19" (an improvement) |
| Navigation interface | Yes | Yes | Yes | Yes |
| Image post-processing | Yes | Yes | Yes | Yes |
| DICOM Functionality | Yes | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: More than 70 patients were examined during the clinical evaluation (customer use test).
- Data Provenance: The data was generated during a "customer use test" in a clinical environment. The country of origin is not explicitly stated, but Siemens Medical Systems, Inc. is based in Malvern, PA, USA, and the manufacturing site is in Kemnath, Germany. Given this is a 510(k) submission to the FDA, it is highly likely that at least some, if not all, of the clinical evaluation was conducted in the USA or in a manner compliant with US regulatory requirements. The data is prospective, as it was a specific evaluation conducted for 8 weeks in a clinical environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
The document states: "It was the investigators opinion that in this test phase the new Cios Alpha provided an even better, more detailed image quality as compared to the ARCADIS Avantic (predicate device)."
- Number of Experts: The document refers to "investigators" (plural) but does not specify an exact number.
- Qualifications of Experts: The qualifications of the "investigators" are not explicitly stated, but it is implied they are healthcare professionals who are experienced in evaluating medical imaging devices in a clinical setting ("customer use test," "clinical environment").
4. Adjudication Method for the Test Set:
The document describes the assessment as "the investigator's opinion." This suggests a qualitative assessment by the clinical investigators, rather than a formal, multi-reader adjudication process (e.g., 2+1 or 3+1). It does not mention blinding or independent review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The clinical evaluation was a customer use test where investigators provided an opinion on image quality compared to the predicate, but it does not detail a structured study comparing human reader performance with and without AI assistance or with the new device versus the predicate in a statistically rigorous MRMC design.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Cios Alpha is an imaging device, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance as typically applied to AI/CAD devices is not relevant here. The device's performance is based on its ability to produce images. The non-clinical tests involved compliance with various IEC/ISO standards and X-Ray performance tests, which evaluate the device itself.
7. The Type of Ground Truth Used:
For the clinical evaluation, the "ground truth" for image quality was based on the subjective expert opinion/consensus of the clinical investigators. The document mentions the "investigators opinion" regarding image quality being "even better, more detailed" compared to the predicate. This is a qualitative assessment rather than a definitive objective measure like pathology or clinical outcomes.
8. The Sample Size for the Training Set:
The Cios Alpha is a fluoroscopic X-ray system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The document describes its development as being "based on the ARCADIS Avantic and the experience Siemens has with more than 30 years with predicate mobile fluoroscopy C-arms (SIREMOBILE series)." This refers to product development experience and engineering, not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set was Established:
As the Cios Alpha is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set is not applicable to this submission. The device's design and performance are a result of engineering principles, compliance with standards, and experience with prior generations of fluoroscopy systems.
§ 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.