(48 days)
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.
The MULTIX Impact E 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 detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:
- A new X-ray Tube Assembly
- A new Collimator
- A new Generator
- Fixed patient table
- Tube-side control module (TCM)
- Upgraded software version to VB10 to support hardware modifications
The modified system will be branded as the MULTIX Impact E.
This document describes modifications to an existing X-ray system, the MULTIX Impact E, and asserts its substantial equivalence to a predicate device, the MULTIX Impact (K203345).
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly equivalence in safety and effectiveness to the predicate device, despite modifications. The performance is assessed through verification and validation testing of the modified components to ensure they do not negatively impact safety and effectiveness and perform as intended.
| Attribute | Predicate Device (MULTIX Impact VA20, K203345) Performance | Subject Device (MULTIX Impact E VB10) Performance | Comparison Results / Acceptance Criterion (Implicit) |
|---|---|---|---|
| Indications for Use | Radiographic system for whole body (skull, chest, abdomen, extremities) on pediatric, adult, bariatric patients, standing, sitting, or prone. Uses digital detectors, film/screen, or CR cassettes. Not for mammography. | Radiographic system for whole body (skull, chest, abdomen, extremities) on pediatric, adult, obese patients, standing, sitting, or prone. Uses digital detectors, film/screen, or CR cassettes. Not for mammography. | Same (Meets implied acceptance criterion of retaining same indications for use) |
| Detector | Wireless detector: Mars1717VS | Wireless detector: Mars1717VS | Same (Meets implied acceptance criterion of retaining same detector technology) |
| Tube Stand (TS) | Independent semi-motorized TS (Manual tilt, manual longitudinal, motorized lift) | Integrated fully manual TS (Manual tilt, manual longitudinal, manual lift) | Different. Performance reduced for lower cost. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| X-ray Tube | RAY-14S 3F tube (Anode heat: 260KJ; Input Power: 78KW; Anode rotary freq: ~8500-10800 rpm) | RAY-12 3S tube (Anode heat: 170KJ; Input Power: 54KW; Anode rotary freq: 3000/3600 rpm) | Different. Performance reduced for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Collimator | Manual collimator without feedback to system | Manual collimator with feedback (Blade positions, Cu filter status) to system | Different. Function improved to support more operational possibilities. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness and potentially improving functionality) |
| Generator | 55KW/65KW/80KW high frequency X-ray Generator (3-phase, 380-480V) | 50KW high frequency X-ray Generator (3-phase, 380-480V); Additionally: 40KW high frequency X-ray Generator (1-phase, 208-230V) | Different. Configuration reduced for 3-phase, and a new 1-phase option added. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Automatic Exposure Control (AEC) | 5 fields AEC module with CAN interface to system | 3 fields AEC chamber with analog interface to system | Different. Modified for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Patient Table | Fixed table without rail | Fixed table with integrated rail mounting tube stand | Different. Modified for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Human Machine Interface (HMI) | Touch User Interface module (TUI); Remote Interface supported by Siemens tablet. | Tube-side control module (TCM) with SID, tube angle display, brake release; Touch User Interface module (TUI). | Different. TCM added, Remote Interface (tablet) removed. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| UI (User Interface) on Imaging System | Siemens UI concept | Siemens UI concept | Same (Meets implied acceptance criterion of retaining same user interface concept) |
| Software version | VA20 | VB10 | Different. Updated to support hardware modifications. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document extensively refers to "verification and validation testing" without specifying a distinct "test set" in terms of patient data or image data. The testing appears to be focused on hardware and software performance/functionality testing of the new components and the integrated system. There are no mentions of patient images or clinical data as a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The provided document does not describe a clinical study involving experts establishing ground truth for a diagnostic test set. The testing described is technical verification and validation of the device's components and system functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a diagnostic test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an X-ray system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a diagnostic test set. For the verification and validation described, the "ground truth" would be the engineering specifications, performance standards (e.g., IEC, ANSI, NEMA), and safety requirements that the new/modified components and the integrated system are assessed against.
8. The sample size for the training set
Not applicable. This is not a machine learning model requiring a training set. The software mentioned is system control software, validated through standard software development lifecycle processes.
9. How the ground truth for the training set was established
Not applicable.
§ 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.