(263 days)
The SOMATOM Scope and SOMATOM Scope Power 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.
The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)
The provided text describes a 510(k) summary for the Siemens SOMATOM Scope/Scope Power Computed Tomography X-ray Systems. This document focuses on demonstrating the substantial equivalence of a new software version (SOMARIS/5 VC30 syngo® CT VC30-easylQ version) to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided, noting the limitations of the document for some specific requests:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific quantitative targets for "device performance" in the way one might expect for a new diagnostic algorithm's sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating conformance to established standards and the successful verification and validation of software functionalities.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Conformance to Regulatory Standards | Fulfilled requirements of: |
- IEC 60601-2-44: Safety of X-ray equipment for CT
- IEC 61223-3-5: Acceptance tests - Imaging performance of CT X-ray equipment CORRIGENDUM 1
- NEMA XR-25: Computed Tomography Dose Check
- IEC 61223-2-6: Constancy tests - Imaging performance of CT X-ray equipment
- NEMA PS 3.1 3.20 (2011): DICOM Set
- IEC 62304 Ed. 1.0: Medical device software life cycle processes
- IEC 60601-1: General requirements for Safety, 2005
- IEC 60601-1-6 : 2010; Usability
- ISO 14971: Application of risk management to medical devices
- NEMA XR-29: Dose Optimization and Management
- NEMA XR-26: Access Controls
- IEC/ISO 10918: Digital Compression and Coding
- 60601-1-2 (2007): Electromagnetic Compatibility |
| Software Verification/Validation | Accepted results for: - All software specifications met acceptance criteria.
- Testing for verification and validation of the device was found acceptable to support claims of substantial equivalence.
- Performance tests demonstrate the subject device performs as intended for included features. |
| Risk Analysis and Control | Risk analysis was completed, and risk control implemented to mitigate identified hazards. |
| General Safety and Effectiveness (Labeling) | Device labeling contains instructions for use and necessary cautions/warnings for safe and effective use. |
| Substantial Equivalence | The proposed device has the same intended use and comparable indication for use as predicate devices. Technological characteristics (image acquisition, operating platform, image manipulation) are similar. The results of non-clinical tests and software validation demonstrate the subject device is as safe and effective as predicate devices. |
Note: This is a 510(k) for a software update to an existing CT system. The primary goal is to show substantial equivalence, not necessarily to prove efficacy for new clinical claims with extensive performance metrics like sensitivity/specificity. The focus is on ensuring the new software features do not introduce new safety or effectiveness concerns and maintain the performance of the cleared predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in terms of patient cases or imaging data used for a test set for clinical performance evaluation. The testing described is primarily non-clinical verification and validation of software functionalities and adherence to technical and electrical safety standards.
- Sample Size for Test Set: Not specified in terms of patient data or images. The testing seems to be functional and engineering-level.
- Data Provenance: Not specified, as it's primarily non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The document describes non-clinical software and system performance testing, not a clinical study involving ground truth established by medical experts.
4. Adjudication Method for the Test Set
Not applicable, as it's not a clinical study requiring adjudication of expert interpretations.
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 study was mentioned or performed. This document is for a CT system software update, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Computed Tomography X-ray System. While it has extensive software, it is not an "algorithm only" device in the AI sense. Its "standalone performance" refers to its ability to acquire and reconstruct images according to its specifications and regulatory standards, which was tested non-clinically. The document confirms that "performance tests were conducted to test the functionality of the SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version."
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 the non-clinical testing would be the engineering specifications and expected behavior of the software and hardware components.
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) for a CT system's software update, not a machine learning algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
§ 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.