(129 days)
The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Siemens intends to market a new software version, syngo® VA48 (SOMARIS/7 VA48) for its SOMATOM Definition Edge Computed Tomography X-ray systems. The subject device SOMATOM Definition Edge will be delivered with software version syngo® VA48 (SOMARIS/7 VA48). Additionally software version synqo® VA48 (SOMARIS/7 VA48 will be offered as an optional upgrade for existing SOMATOM Definition Edge systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.
This document is a 510(k) summary for the Siemens SOMATOM Definition Edge Computed Tomography Systems with software version syngo® VA48. It demonstrates substantial equivalence to previously cleared predicate devices.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics for the SOMATOM Definition Edge with syngo® VA48. Instead, it states that the device is "designed to fulfill the requirements of the following standards" and that "The testing results supports that all the software specifications have met the acceptance criteria."
The listed standards include:
- IEC 60601-2-44: Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography - Ed. 2.1
- IEC 61223-3-5: Evaluation and routine testing Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
- NEMA XR-25: Computed Tomography Dose Check
- IEC 61223-2-6: Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
- NEMA PS 3.1 3.18: Digital Imaging and Communications in Medicine (DICOM) Set
- IEC 62304 Ed. 1.0: Medical device software software life cycle processes
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for Safety, 1988, Amendment 1, 1991-11, Amendment 2, 1995
- ISO 14971: Medical devices Application of risk management to medical devices
- NEMA XR-29: Standard Attributes on CT Equipment Related to Dose Optimization and Management
The document generally states that "Performance tests were conducted to test the functionality of the SOMATOM Definition Edge configured with software version syngo® VA48. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of any clinical data. The submission focuses on non-clinical testing and software validation. It mentions that "The predicate devices were cleared based on non-clinical supportive information and clinical images," but does not explicitly state that new clinical images were used for this particular submission's test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is non-clinical performance and software validation.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in this 510(k) summary. The document focuses on demonstrating substantial equivalence through non-clinical testing and software validation, not on comparative effectiveness with human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The document describes non-clinical technical performance tests and software verification/validation, indicating a standalone evaluation of the device's functionality. It states: "Non clinical tests were conducted for the SOMATOM Definition Edge configured with software version syngo® VA48 during product development. The modifications described in this Premarket Notification were supported with verification/validation testing." However, this is for the CT system itself, not an AI algorithm in the contemporary sense. The "AI" components listed (ADMIRE Iterative Reconstruction, iMAR Improved Metal Artifact Correction, MARIS) are features of the CT imaging chain rather than separate diagnostic AI algorithms requiring individual standalone performance evaluation in this context.
7. Type of Ground Truth Used
For the non-clinical testing and software validation, the ground truth would be defined by the technical specifications and expected performance characteristics of the CT system and its software features, as outlined in the referenced IEC and NEMA standards. There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as this submission is for a CT system update, not a diagnostic AI algorithm.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The document describes an update to a CT imaging system's software version, not a machine learning model that undergoes a distinct training phase with a specific training set. The "features" like ADMIRE, iMAR, and MARIS are advanced image reconstruction and processing techniques, not typically "trained" on a dataset in the way a deep learning model is.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.