(39 days)
The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The Multitom Rax is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal. thoracic and lung exposures as well as examination of the urogenital tract. The unit may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA).
The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Multitom Rax is not for mammography examinations.
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table and ceiling suspended X-ray tube and a ceiling suspended solid state X-ray imager (SSXI). Together with an X-ray generator and a digital imaging system the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
The provided text is a 510(k) summary for the Siemens Multitom Rax, an X-ray imaging system. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria in a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies (MRMC, standalone algorithm performance) is not explicitly detailed in this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table with specific quantitative acceptance criteria or device performance metrics in the format of a clinical study. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a clinical test set with human subjects to evaluate performance against specific acceptance criteria. The "tests" mentioned are primarily non-clinical verification and validation activities and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set with adjudication is described.
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
No MRMC comparative effectiveness study was done. The device described is an X-ray imaging system, not an AI-powered diagnostic algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an X-ray imaging system, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth is described. The "ground truth" in this context refers to the successful verification against engineering specifications and compliance with safety standards for the device's components and functionality.
8. The sample size for the training set
Not applicable. This is an X-ray imaging system undergoing a 510(k) submission based on substantial equivalence, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
Summary of the Study and Evidence Presented for Device Acceptance (Substantial Equivalence):
The Siemens Multitom Rax obtained a 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:
The "study" that proves the device meets the acceptance criteria (substantial equivalence) is a combination of non-clinical verification and validation testing and compliance with recognized standards.
Here's the evidence presented:
- Indications for Use: The Multitom Rax has identical indications for use as the Primary predicate AXIOM Luminos dRF (K062623).
- Technological Characteristics:
- The Multitom Rax uses the same X-ray generator, X-ray tube, solid state X-ray imager (SSXI), digital imaging system, and image processing software as the Primary predicate AXIOM Luminos dRF.
- The system control (in-room or remote) is the same fashion as the Primary predicate AXIOM Luminos dRF.
- The mechanical design concept is the same as the Secondary predicate AXIOM Aristos FX Plus.
- Changes implemented involve enhanced movement flexibility of suspension arms, increased number of predefined automatic positions, optimized software algorithm for faster movement, and a more sophisticated collision software. These features were also available in the secondary predicate to some extent (e.g., automatic positioning).
- The automatic exposure control processes data from 5 dose measurement fields instead of 3 (compared to predicate devices).
- Increased number of organ programs, including additional pediatric applications.
- Non-Clinical Test Data:
- Design completed in accordance with Siemens Quality Management System Design Controls and Engineering.
- Verification and Validation testing were successfully conducted.
- Tests demonstrated the device is safe and effective, performs comparably to predicate devices, and is substantially equivalent.
- Tests included verification/validation testing to internal functional specifications (including software).
- Since the Multitom Rax uses the same SSXI as the Primary predicate and X-ray geometry and techniques are the same, clinical image comparisons involving SSXI were not conducted.
- Compliance documentation for software (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) was provided, including results of verification/validation tests for software requirements and risk hazards.
- Performance Standards Compliance:
- Confirmed compliance with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment.
- Complies with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically numerous IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62366, ISO 14971, IEC 62304, IEC 60601-2-28, IEC 60601-2-54, IEC 61910-1, NEMA PS 3.1 - 3.20, IEC 60825-1, ISO 10993-1, IEC 60601-2-43).
- Conclusion: The verification/validation activities confirmed that device requirements were fulfilled, system functionality is consistent with user needs and intended uses, and the device performs as designed without raising new questions regarding safety or effectiveness, thus supporting a determination of substantial equivalence.
§ 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.