(135 days)
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting X-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The MULTIX Impact (VA11) Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K182517). The following modifications have been made to the predicate device:
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- A new 43*43cm wireless detector, Mars1717VS manufactured by iRay
- A new 43*43cm fixed detector, Venu1717X manufactured by iRay 2.
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- A new Remote Interface used for patient examination management
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- Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface.
- న. New Bucky Wall Stands
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- New patient table
The new system will be branded as the MULTIX Impact.
This is an FDA 510(k) summary for the MULTIX Impact (VA11) radiography x-ray system, which is a modification of an existing device (MULTIX Impact, K182517). The submission aims to demonstrate substantial equivalence to the predicate device, rather than proving the device meets a new set of performance acceptance criteria through a comparative clinical study.
Therefore, many of the typical acceptance criteria and study details for novel AI medical devices are not explicitly stated in this document. The focus is on demonstrating that the modifications made do not negatively impact safety and effectiveness and that the new device performs comparably to the predicate.
However, I can extract the relevant information regarding performance aspects that were tested and compared.
Here's a breakdown based on the provided text:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a substantial equivalence submission for modifications to an existing device, there aren't new specific quantifiable acceptance criteria in the typical sense for a brand new AI device. Instead, the "acceptance criteria" are implied to be at least equivalent or improved performance compared to the predicate device in key technical specifications.
| Characteristic Measured/Compared | Acceptance Criteria (Implied: Equivalent or Improved vs. Predicate) | Reported Device Performance (Subject Device - MULTIX Impact VA11) | Notes/Comparison Results |
|---|---|---|---|
| Indications for Use | Same as predicate | Same as predicate | Same |
| Imaging Detectors (for RAD imaging) | Performance equivalent or improved; no impact on image quality. | Introduces iRay Mars1717VS (wireless) and iRay Venu1717X (fixed) detectors. | Different. Performance testing and co-existence testing concluded no impact on image quality. |
| HMI (Human Machine Interface) | Same as predicate | Touch user interface (same as predicate) | Same |
| Remote Interface | No impact on safety and effectiveness (as this is a new option) | Supported by Siemens provided tablet meeting minimum requirements. | Different. Performance testing and co-existence testing concluded no impact on safety and effectiveness. |
| UI (User Interface) on Imaging System | No impact on safety and effectiveness. | Color scheme is grey (dark); Button shape is rounded or pill-shaped. | Different. Performance testing concluded no impact on safety and effectiveness. |
| Software Version | No impact on safety and effectiveness. | VA11 | Different. Improved to support hardware modifications and Remote Interface; performance testing concluded no impact on safety and effectiveness. |
| Bucky Wall Stand (BWS) | No impact on safety and effectiveness; performance unchanged. | For Pixium 3543 EZH: BWS with motorized height adjustment with new functions (option for fixed/selectable left/right detector loading direction). | |
| For Mars1717VS: BWS with manual/motorized height adjustment with new functions and new tray. | |||
| For Venu1717X: BWS with motorized height adjustment with new functions, new tray, additional emergency button and motion switch. | Different. Improved/modified to support new detectors/operational possibilities. Performance testing concluded no impact on safety and effectiveness. | ||
| Patient Table | No impact on safety and effectiveness; performance unchanged. | Elevating Patient table in z-axis for Pixium 3543 EZH (same as predicate). | |
| Fixed and elevating Patient tables in z-axis for Mars1717VS with new tray. | Different (for Mars1717VS due to new tray). Modification to support new detector. Performance is unchanged. Testing concluded no impact on safety and effectiveness. | ||
| Detector Active Area | Equivalent or Improved (larger dimensions, no impact on safety/effectiveness). | iRay Mars1717VS: 426mm x 426mm; 3070x3070 pixels. | |
| iRay Venu1717X: 426mm x 426mm; 3070x3070 pixels. | Different. Improved active area (larger dimensions) no impact on safety and effectiveness. | ||
| Detector Pixel Size | Equivalent or Improved; no impact on safety/effectiveness. | iRay Mars1717VS: 139 µm. | |
| iRay Venu1717X: 139 µm. | Different. Minor change only; no impact on safety and effectiveness. | ||
| Detector Material | Same as predicate. | Amorphous Silicon. | Same. |
| Scintillator | Same as predicate. | Cesium iodide (CsI) 16 bit. | Same. |
| DQE (Detective Quantum Efficiency) @ 1 lp/mm (2 μGy) | Equivalent or improved. | iRay Mars1717VS: 65%. | |
| iRay Venu1717X: 65%. | Different. Minor improvement to DQE; no impact on safety and effectiveness. | ||
| MTF (Modulation Transfer Function) @ 1 lp/mm | Equivalent or improved. | iRay Mars1717VS: 64%. | |
| iRay Venu1717X: 64%. | Different. Minor improvement to MTF; no impact on safety and effectiveness. | ||
| General Safety and Effectiveness Concerns (Overall System) | Conformance to standards; risk mitigation; no new potential safety risk. | Conforms to IEC 60601-1:2012, IEC 60601-1-2:2014, etc. Risk analysis completed, controls implemented. Visual/audible warnings incorporated. | Test results support all software specifications met acceptance criteria. Verification/validation acceptable. Device performs as intended and is comparable to predicate. |
2. Sample Sizes Used for the Test Set and Data Provenance
This document describes a 510(k) submission for modifications to a hardware device (X-ray system), not an AI software. The testing mentioned is primarily non-clinical performance testing (integration, functional, regulatory compliance, risk analysis) rather than clinical studies with patient data.
- Test Set Sample Size: Not applicable in the context of patient image data for an AI algorithm. The testing involves hardware components and integrated system performance. No specific "test set" of patient images is referenced for algorithm evaluation.
- Data Provenance: Not applicable for an AI algorithm. The testing would have occurred internally at Siemens manufacturing and R&D facilities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as the submission focuses on hardware and software modifications of an X-ray system, not an AI algorithm that requires expert-established ground truth for performance evaluation.
4. Adjudication Method for the Test Set
- Not applicable for this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not performed and not applicable. This is not an AI-assisted diagnostic device undergoing a comparative effectiveness study with human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not performed and not applicable. This is not an AI algorithm but a hardware X-ray system with embedded software.
7. Type of Ground Truth Used
- Not applicable for an AI algorithm. The "ground truth" in this context refers to engineering specifications, regulatory standards compliance, and functional performance benchmarks for hardware and system software.
8. Sample Size for the Training Set
- Not applicable as this is not an AI algorithm that requires a training set of patient data.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no mention of a training set or AI algorithm in the provided document.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.