(22 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 pediatric, adult and bariatric 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) which is the same as the predicate device, the Multix Fusion Max (K162971). The portable wireless and integrated detectors used with Multix Fusion Max are imported from the cleared predicate device, Multix Fusion Max (K162971). There are no new imaging detectors added to the subject x-ray system. The Multix Fusion Max software is being used unchanged from the reference device, Ysio Max (K181279). This 510(k) submission describes modifications to the predicate device, the Multix Fusion Max, cleared via K162971.
The purpose of this submission is for the following modifications to Multix Fusion Max:
- Updated operating system from Windows 7 to Windows 10 and software version upgrade from VE21 to VF10
- New cybersecurity features
- Additional pediatric exposure technique factors
- A new 80-line grid with a 15:1 ratio
- The image processing algorithms (DiamondView MAX) will be used for exposures without grid
- The Multix Fusion Max with VF10 has been tested according to the currently recognized voluntary standards.
The provided document is a 510(k) summary for the Multix Fusion Max X-ray system. It describes modifications to an existing device (Multix Fusion Max, K162971) and claims substantial equivalence to that predicate device. The changes include an updated operating system (Windows 7 to Windows 10), software version upgrade, new cybersecurity features, additional pediatric exposure technique factors, and a new 80-line grid.
Crucially, this document does not contain information about a study that proves the device meets specific performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, especially not in the context of an AI-assisted diagnostic device or a multi-reader, multi-case study. The performance testing mentioned is primarily "non-clinical performance testing" for device functionality, safety (electrical, mechanical, radiation), and software verification/validation, rather than clinical performance for diagnostic effectiveness. The document states:
- "Non-clinical tests were conducted for the Multix Fusion Max during product development. The modifications described in this Premarket Notification are supported with verification and validation testing."
- "The testing results indicate that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence."
- "The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use."
The entire premise of the 510(k) submission for this device is to demonstrate substantial equivalence to a previously cleared device, not to prove new or improved clinical effectiveness through a diagnostic performance study. The device is a radiographic system for generating images, not an AI or CAD system that provides diagnostic interpretations or assists human readers in making diagnoses.
Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample size for test sets (in a clinical sense), ground truth establishment, expert readers, MRMC studies, or standalone AI performance do not apply to the information presented in this 510(k) summary.
However, I can extract information related to what was studied to support the 510(k) clearance based on substantial equivalence.
Here's the closest answer based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Study for Multix Fusion Max (K191418)
The provided 510(k) summary for the Multix Fusion Max (K191418) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion Max, K162971) following modifications primarily related to software (operating system upgrade, cybersecurity), and minor hardware changes (new grid, expanded pediatric technique factors). The "study" described is a series of non-clinical verification and validation tests rather than a clinical diagnostic performance study. As such, many of the requested criteria related to AI or diagnostic accuracy studies are not applicable to the content of this document.
1. Table of Acceptance Criteria and Reported Device Performance
General acceptance criteria are related to safety, functionality, and compliance with standards. The document does not provide specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for a clinical study of images, as this was not a submission for an AI/CAD device.
| Aspect Tested | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Software Specifications | All software specifications must be met. | "The testing results indicate that all the software specifications have met the acceptance criteria." |
| Risk Analysis and Control (Hazards) | Identified hazards must be mitigated; device must not introduce new safety risks. | "The risk analysis was completed and risk controls were implemented to mitigate identified hazards." "Does not introduce any new potential safety risk." |
| Compliance with Voluntary Standards | Conformity to relevant standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). | Device "conforms to the following standards: ES60601-1:2005/...; IEC 60601-1-2:2014...; IEC 60601-1-3...; IEC 62366-1...; ISO 14971...; IEC 62304...; IEC 60601-2-28...; IEC 60601-2-54...; PS 3.1 - 3.20 (2016) and ISO 10993-1..." |
| Electrical, Mechanical, and Radiation Hazards | Minimize hazards; comply with established industry practice. | "To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing." |
| Functional Equivalence to Predicate | Device performance comparable to predicate; same intended use. | "The Multix Fusion Max is substantially equivalent to and performs as well as the predicate device." "The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use." |
| Software Documentation (Moderate Level of Concern) | Conformance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software Documentation for a Moderate Level of Concern software... is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software." |
| Verification and Validation Testing (Overall) | Demonstrated safety and effectiveness; supported claim of substantial equivalence. | "Verification and validation testing has been successfully completed and test results show that the subject device... is substantially equivalent to the predicate device." "Verification and validation testing was found acceptable to support the claim of substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical test set of patient images for diagnostic accuracy. The testing performed was non-clinical verification and validation of system functionality and safety.
- Data Provenance: Not applicable for a clinical test set. The document refers to its manufacturing sites in Shanghai, China, and Forchheim, Germany, and the applicant is Siemens Medical Solutions USA, Inc. The testing described is intrinsic to the device's engineering and software.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as the submission describes non-clinical engineering and software validation, not a diagnostic performance study where human experts establish ground truth for image interpretation.
4. Adjudication Method for the Test Set
- Not applicable for the type of non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done or described in this 510(k) summary. This device is a basic X-ray system, not an AI or CAD system designed to assist human readers in diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an X-ray imaging system, not an AI algorithm intended for standalone diagnostic interpretation.
7. The Type of Ground Truth Used
- Not applicable in the context of diagnostic image interpretation. For functional testing, "ground truth" would be established through engineering specifications, direct measurement, and known physical principles.
8. The Sample Size for the Training Set
- Not applicable. This document describes a conventional X-ray system, not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI/ML algorithm is described.
§ 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.