(29 days)
The ControlRad® Select Model Z with the Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z 's region of interest (ROI) as compared to Artis zee non-collimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, bv image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.
1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.
The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system.
The ControlRad® Select Model Z consists of a ControlRad® filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad® filter is installed semipermanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures.
The ControlRad® Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad® Select Model Z is only compatible with the 30 x 40 detector and associated collimator. Use of this system on other sizes is prohibited.
The additional radiation reduction provided by the ControlRad® Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.
The main components of the ControlRad® Select Model Z which are used with the Artis zee are:
- ControlRad® Tablet .
- ControlRad® Filter .
- ControlRad® Hardware ●
- ControlRad® Software and Firmware Modules .
- . ControlRad® Communication Interface
The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.
ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3.0 mm, both of which are partially transparent to X-ray radiation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate device: Provide fluoroscopic imaging while reducing radiation exposure (Dose Area Product) outside of the Region of Interest (ROI). | Same as predicate device, including the specific quantitative claim: "Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV." |
| X-ray Radiation Source | Siemens Medical Solutions, Inc. Artis zee | Same as predicate. |
| System Configuration | ControlRad Filter and Image Processing SW/HW mounted on Artis zee | Comparable to predicate, with the exception of the size of the ControlRad hardware to attach to the collimator for the Siemens Artis zee 30x40cm detector. Bench Testing and System Validation Testing Summaries provided. |
| X-ray Modulation Component | CR Filter 2.5mm thru 3.0mm | Same as predicate. Bench Testing and System Validation Summaries provided. |
| X-ray Radiation Modulation | Semi-transparent filter; Reduces radiation outside the aperture typically by 44% to 98%. | Same as predicate. Bench Testing and System Validation Summaries provided, demonstrating safety and effectiveness comparable to the predicate. |
| Aperture shape | Blades: Rectangular | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Aperture Control | Set by the user using the CR Tablet | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Image Area Processed | Area outside ROI | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Processing Bits | 16 bits | Same as predicate. Bench Testing and System Validation Summaries provided. |
| Processing Rate | 30 fps | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Processing Occurrence | Area outside ROI: Only when the CR Filter is engaged. | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Image Layout Information | All image layout information originally available for Siemens Artis zee plus: Percentage of Dose Area Product (DAP) reduction, ROI frame border. | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Dose Area Product (DAP) Accuracy for total x-ray field | ±35%* | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Electrical Requirements | Artis zee Components: AC 400 V ± 10 %, 50/60 Hz ± 1 Hz; ControlRad Components: SCIP BOX Input: 230 VAC, 0.6A; TABLET POWER SUPPLY Input: 24 VDC, 0.5A; SELECT FILTER Input: 28 VDC, 0.9A; ROUTER Input: 12DC, 1A; ROUTER POWER SUPPLY Input: 230VAC, 0.5A. | Same as predicate. Bench Testing and System Validation Testing Summaries provided. |
| Software Verification | Verification of v3.0.5 software. | Completed. |
| Impact of Air Kerma (ControlRad components) | Not significantly increase Air Kerma when compared to Artis zee alone. | Verified. |
| Impact of Cover on Air Kerma | Not affected by the ControlRad® cover (with/without Aluminum) vs. Siemens cover (with/without Aluminum). | Verified. |
| Air Kerma and Air Kerma Rate Accuracy | ±35% of the Artis zee system alone per 21 CFR 1020.32. | Verified. |
| Radiation Dose Structure Report (RDSR) AK Accuracy | ±35% of the Artis zee system alone. | Verified. |
| Reference Air Kerma Warning Functionality | Not impacted when compared to the Artis zee system alone. | Verified. |
| CT Dose Area Product (DAP) Accuracy | ±35% of the Artis zee system per IEC 60601-2-43. | Demonstrated. |
| CT Dose Area Product (DAP) Reduction | Reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the size of the full FOV. | Verified. |
| Accuracy of Procedure Dose Indicators | Not exceed ±35% for any of the dose indicators. | Verified. |
| ControlRad® Filter Attenuation | Contributes to reduction of Dose Area Product (DAP). | Verified. |
| Leakage Radiation Evaluation | No unacceptable impact on reference device leakage radiation measurements. | Evaluated. |
| Stray Radiation Evaluation | No unacceptable impact on reference device stray radiation measurements. | Evaluated. |
| Recovery Management | Compliant with IEC 60601-2-43, section 201.4.101. | Verified. |
| Mechanical Impact on Filter Cover | Does not create unacceptable risk per IEC 60601-1 requirements. | Verified. |
| Anti-Collision Detection | Function in accordance with Siemens Artis zee with ControlRad® Select Model Z filter / collimator cover installed. | Verified. |
| Focal Spot to Patient Distance | Compliant with IEC 60601-2-54, section 203.9 requirements. | Verified. |
| Tensile Strength Evaluation | Does not create unacceptable risk from tensile strength per IEC 60601-1 requirements. | Verified. |
| Filter Motion Assembly Reliability | Reliable over the expected service life of the filter assembly. | Verified. |
| Comparative image quality inside the ROI | At least the same quality as the image gathered with the Artis zee alone. | Verified. |
| Comparative image quality outside the ROI | Clinically relevant following degradation due to use of the ControlRad filters. | Characterization testing to quantify degradation and image quality evaluation via clinical simulations for validation. |
| DAP Chamber Change | Justification of the change from the original chamber used in the Artis zee system. | Justified. |
| Wireless Devices and Cybersecurity Evaluation | Compliance with FDA Guidance documents. | Evaluated. |
| Cybersecurity Controls & Justification for Control of Risk | Verified. | Verified. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., number of images, number of patients). However, it lists various tests conducted, including:
- Software Verification: v3.0.5 software.
- Impact, Accuracy, and Reduction tests related to Air Kerma and Dose Area Product (DAP): These are quantitative measurements performed on the device.
- Image quality evaluation via clinical simulations: This suggests a test set related to clinical scenarios.
The data provenance is implied to be prospective testing conducted by ControlRad, Inc. during product development. The tests are focused on the device's functional performance and adherence to standards rather than analysis of patient data from a specific origin. There is no mention of country of origin for the data or whether it was retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" for a specific test set, as this is not a diagnostic AI device requiring expert interpretation for label generation. The tests performed are primarily engineering and performance verification tests against established technical specifications and regulatory standards.
For "Image quality evaluation via clinical simulations," while the document indicates that the image quality outside the ROI was validated as "clinically relevant," it does not specify the number or qualifications of experts involved in this validation.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the studies are largely technical performance verifications against predefined criteria and standards, not studies requiring adjudication of diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No. An MRMC comparative effectiveness study involving human readers and AI assistance was not done. The ControlRad® Select Model Z is a system that modifies the fluoroscopic image acquisition to reduce radiation, not a diagnostic AI that assists human readers in interpreting images. Its primary benefit is radiation dose reduction while maintaining image quality within the ROI and providing contextual information outside it.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in essence, the majority of the performance verification tests listed were effectively "standalone" tests of the device's technical and physical performance metrics without human interpretation in the loop. These include:
- Air Kerma and DAP accuracy and reduction tests.
- Software verification.
- Mechanical and electrical requirement verifications.
- Filter attenuation, leakage radiation, and stray radiation evaluations.
The "Comparative image quality inside the ROI" and "Comparative image quality outside the ROI" also evaluate the output of the system (images) directly against defined quality criteria.
7. The Type of Ground Truth Used:
The "ground truth" for the various performance tests is based on established technical specifications, regulatory standards, and physical measurements. For example:
- Dose Area Product (DAP) Accuracy: Based on standards like IEC 60601-2-43 and 21 CFR 1020.32, with an acceptance criterion of ±35%.
- Radiation Modulation/Reduction: Based on the device's design specification (e.g., reduces at least 85% of DAP at 65 kVp under certain ROI conditions; typically reduces radiation outside the aperture by 44% to 98%).
- Image Quality: Verified against the image quality of the Artis zee system alone within the ROI, and characterized for clinical relevance outside the ROI. These would involve objective image quality metrics.
- Safety Standards: Adherence to standards like ISO 14971, IEC 60601 series, and FDA 21 CFR 1020.30-32.
8. The Sample Size for the Training Set:
This information is not provided in the document. The ControlRad® Select Model Z is a hardware and software system for X-ray modulation, not a machine learning model developed with a distinct "training set" in the context of diagnostic AI. While it uses software and firmware, the document describes performance testing rather than machine learning model validation based on a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as a distinct training set (in the context of machine learning for diagnostic inference) and its ground truth establishment are not described for this device. The software and firmware within the device control the physical mechanisms (filters, etc.) and process images based on pre-defined algorithms and physical principles, rather than learning from a labeled training set in the typical AI sense.
§ 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.