(28 days)
Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatic, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion Max system is not meant for mammography.
Multix Fusion Max uses a mobile(wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The Multix Fusion Max Radiography X-ray system is a modular system of x-ray components (ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and integrated detectors) same as the predicate the Multix Fusion. This 510(k) submission describes modifications to the predicate device the Multix Fusion cleared via K142049.
The provided text is a 510(k) summary for the Siemens Multix Fusion Max X-ray system. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to demonstrating substantial equivalence, not typically a clinical performance study with specific metrics like sensitivity or specificity for an AI-powered diagnostic device.
This document describes the device as a radiographic system with various hardware and software modifications compared to its predicate. The "acceptance criteria" here are primarily about demonstrating that the new modifications do not introduce new safety concerns and that the device performs functionally similarly to its predicates.
Here's an analysis of the provided information, framed within your request, but acknowledging the nature of a 510(k) for a general radiography system rather than an AI diagnostic algorithm:
1. Table of Acceptance Criteria (as implied by a 510(k) for an X-ray system) and Reported Device Performance
For an X-ray system like the Multix Fusion Max, "acceptance criteria" are defined by its substantial equivalence to predicate devices, focusing on technical specifications, safety, and operational performance. The "performance" is the demonstration that these are met or that differences are not significant and do not raise new safety/effectiveness questions.
| Acceptance Criteria (Implied by 510(k) Process for X-ray System) | Reported Device Performance |
|---|---|
| Similar Indications for Use | "Same" as predicate (Multix Fusion K142049) and within same classification regulation. |
| Similar Technological Characteristics (Hardware) | Many components are "same" (e.g., tube, generator, ceiling-mounted support, imaging system). New components (detectors, Bucky wall stand, table, grid) have comparable specifications (e.g., DQE, MTF values are "Difference not significant" or "Same"). Wireless Bucky wall stand is "Only motorized height adjustment" (compared to predicate's motor/manual option) which is a functional difference, but not affecting safety or fundamental performance. |
| Similar Technological Characteristics (Software) | Operating system upgraded from Windows XP to Windows 7; software version VE21. Compliance with software guidance documents is stated. Tested for "continued conformance with special controls for medical devices containing software." |
| Safety and Effectiveness Not Compromised | Non-clinical tests (verification and validation) were conducted. Conformance to various IEC and ISO standards (e.g., IEC 60601-1:2012, ISO 14971:2007 for risk management). Risk analysis completed and risk control implemented. Software testing demonstrated all specifications met acceptance criteria. Visual and audible warnings are incorporated, and error messages are displayed if an error occurs. |
| Image Quality (for new detectors) | Comparative tables show "Difference not significant" or "Same" for key image quality metrics (DQE, MTF, pixel size, resolution) between new and predicate detectors. Functional tests included exposure workflow, detector sharing, and image resend. Image quality tests included flat field uniformity. |
| No New Safety Risks Introduced | "Siemens is of the opinion that the Multix Fusion Max does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
This is an X-ray system submission, not a study of an AI-powered diagnostic device. Therefore, there isn't a "test set" in the sense of a dataset of patient images for an AI algorithm. The testing described is primarily non-clinical, focusing on system function, image quality a phantom/test environment, and safety standards compliance.
- Sample Size: Not applicable in the context of clinical "test set" for an AI algorithm. Non-clinical tests were conducted at the product development stage, but specific "sample sizes" of components or tests are not detailed.
- Data Provenance: Not applicable. The "data" are internal testing results, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no mention of expert readers or ground truth establishment in this type of 510(k) submission for a general X-ray system. The performance demonstration is based on technical specifications and engineering tests.
4. Adjudication Method for the Test Set
Not applicable.
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 is not an AI-powered diagnostic device, and no MRMC study is mentioned or required for this type of submission.
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 an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical ground truth. The "ground truth" for this device's performance demonstration relies on engineering specifications, adherence to international standards (e.g., IEC, ISO), and performance metrics like DQE and MTF measured in a controlled environment, not clinical outcomes or expert labels.
8. The Sample Size for the Training Set
Not applicable. This is an X-ray system, not an AI algorithm requiring a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
In summary, the provided document
describes a 510(k) premarket notification for a conventional X-ray system, not an AI-powered diagnostic device. Therefore, the questions related to AI algorithm development, clinical datasets, expert ground truth, and reader studies are not addressed and are not applicable to this type of device submission. The acceptance criteria are based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with recognized standards.
§ 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.