(143 days)
The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion 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 system is not ment for mammography. The Multix Fusion uses a mobile (wired), or fixed (integrated) or wreless digital detector for generating diagnostic images signals. The Multix Fusion is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Siemens Medical Solutions USA, Inc. intends to market a Radiography X-ray system the Multix Fusion VA30 and VA40. This 510(k) submission describes several modifications to the previously cleared predicate devices the Multix Fusion K121513 and the YSIO Max Radiography X-ray system K133259. The following Modifications are made to the cleared predicate devices and developed into the Subject Device the Multix Fusion VA 30 and VA40:
1). A new 43x43cm fixed detector, Pixium 4343RG manufactured by Trixell; 2). A new 43x36cm wireless detector, Paxscan 4336W manufactured by Varian. 3). A new 43x43cm fixed detector, Pixium 4343RC manufactured by Trixell. 4) Slight change in the Indication for Use Statement as compared to the secondary predicate Ysio Max K133259). 5). Bucky Wall Stand (BWS) changed from manual to motor driven movement. 6). Radiographic Grid change from movable 50-line grid to stationary 80-line grid. 7). A remote control console to control BWS motorized movement, center align, collimator size and collimator light and 8). An optional Multix DR-Upgrade with wireless detector (Varian Paxscan 4336W) for the predicate the Multix Fusion, K121513 is also available within Multix Fusion VA40.
The Multix Fusion VA30 and VA40 Radiography X-ray system is designed as 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 the Multix Fusion K121513.
This FDA document is a 510(k) summary for the Siemens Multix Fusion VA30 and VA40 X-ray system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting performance as one would for a novel AI device with specific performance metrics.
Therefore, the requested information cannot be fully provided from the given document as it does not contain the level of detail regarding acceptance criteria, specific device performance numbers, sample sizes for test sets, expert qualifications, or details about comparative effectiveness studies typically found in submissions for AI/ML devices.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or numerical performance metrics (e.g., sensitivity, specificity, AUC) for the Multix Fusion VA30 and VA40. The evaluation is based on demonstrating that modifications do not affect the intended use and that the device conforms to various performance standards and safety regulations.
The "acceptance criteria" are implied by adherence to:
- Performance standards: IEC 60601-1 (various editions), IEC 62366, ISO 14971, IEC 62304, PS 3.1 - 3.20 (DICOM), IEC 60601-1-6, ISO 10993-1.
- Safety and Effectiveness: Demonstrated through verification and validation testing, risk analysis, and conformance to EMC/electrical safety standards.
- Substantial Equivalence: The core acceptance is that the device is "substantially equivalent" to predicate devices (Multix Fusion K121513 and YSIO Max K133259) in terms of intended use, design, material, functionality, technology, and energy source, and that it does not introduce new safety risks.
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 primarily discusses non-clinical performance testing (verification and validation testing, integration and functional tests, risk analysis). It explicitly states: "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no mention of a test set with human patient data or its provenance for evaluating the device's diagnostic performance for the new modifications.
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, as clinical testing with a human-read test set for diagnostic performance was not performed or deemed necessary for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as clinical testing with a human-read test set for diagnostic performance was not performed or deemed necessary.
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 such study was conducted or reported. This device is a stationary 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 device is a physical X-ray system, not a standalone algorithm. Its performance is evaluated based on its technical specifications, conformance to standards, and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical and verification/validation testing mentioned, the "ground truth" would be established by engineering specifications, calibration standards, and adherence to recognized industry and regulatory standards (e.g., verifying radiation output against expected values, confirming software functionality as per design documents, ensuring electrical safety within limits). There is no patient-level ground truth in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is an X-ray system. The modifications are related to physical components (detectors, Bucky stand, grid, etc.) and associated software for controlling the system, not a machine learning algorithm trained on a dataset.
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.