(79 days)
The Siemens SOMATOM Definition Edge, SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of xray 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.)
The Siemens SOMATOM Definition AS/AS* and SOMATOM Definition Edge equipped with syngo CT VA48 are Computed Tomography X- ray Systems. which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Definition AS/ AS* and SOMATOM Definition Edge produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.
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 version of system software, syngo CT VA48, supports functionality such as Twin Beam scanning, Fast 3D Align, TrueD 4D Viewer, Fast DE evaluation and improved functionality with extended Field of View. The computer system delivered with the CT scanner is able to run optional post processing applications.
In addition to the previously supported software functionality, which was cleared for the FAST DE Result evaluation of Dual Source and Single Source (dual spiral) data, the subject device will support the FAST DE Result evaluation of data acquired with TwinBeam technology. FAST DE Results evaluation allows to use the optional post-processing features Monoenergetic Plus and Virtual Enhanced.
The Siemens SOMATOM Definition AS/AS+ and SOMATOM Definition Edge (with software version syngo CT VA48) is a Computed Tomography X-ray System. Its primary function is to produce cross-sectional images of the body by computer reconstruction of x-ray transmissions data. The device was evaluated to demonstrate continued conformance with special controls for medical devices containing software.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Conformance with safety and performance standards | The device is designed to fulfill the requirements of IEC 60601-2-44, IEC 61223-3-5, NEMA XR-25, IEC 61223-2-6, NEMA PS 3.1 3.20 (DICOM), IEC 62304 Ed. 1.0, IEC 60601-1, ISO 14971, NEMA XR-29, and IEC/ISO 10918. |
| Software specifications meet acceptance criteria | Testing results support that all software specifications have met the acceptance criteria. |
| Functionality of FAST DE Results for TwinBeam Data | Performance tests, including phantom bench testing and retrospective analysis of available patient data, were conducted for the Monoenergetic Plus and Virtual Unenhanced application classes within the FAST DE Results for TwinBeam Data software module. Supportive articles demonstrating usability were provided. The results of these tests demonstrate that the subject device performs as intended. |
| Substantial Equivalence with predicate devices | The device has the same intended use, comparable indications for use, and similar technological characteristics (image visualization, operating platform, image manipulation) as the predicate devices (Siemens SOMATOM Definition AS/AS+ K143400 and SOMATOM Definition Edge K143401 configured with software version SOMARIS/7 VA48). Any differences do not raise different questions of safety or effectiveness. |
| Verification/validation testing for modifications | Modifications described in the Premarket Notification were supported with verification/validation testing. |
| Risk analysis and control | Risk analysis was completed, and risk control was implemented to mitigate identified hazards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases/patients. The document mentions "retrospective analysis of available patient data" and "supportive articles that demonstrate the usability," but does not provide a specific numerical sample size for this patient data.
- Data Provenance: The document states "retrospective analysis of available patient data." The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The document mentions "supportive articles that demonstrate the usability," which might imply expert review, but no details are given about the number or qualifications of experts for establishing ground truth on the test set.
4. Adjudication Method for the Test Set:
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done with human readers comparing performance with and without AI assistance. The study focuses on the device's technical performance and its equivalence to predicate devices, not on human reader improvement with AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted for the device's software functionalities. The performance tests ("Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Monoenergetic Plus and Virtual Unenhanced for the FAST DE Results for TwinBeam Data software module") evaluate the algorithm's output directly.
7. The Type of Ground Truth Used:
- The document mentions "phantom bench testing" and "retrospective analysis of available patient data." For phantom testing, the ground truth would be the known properties of the phantom. For retrospective patient data, the type of ground truth is not explicitly stated (e.g., expert consensus on original scans, pathology). However, the context of "supportive articles that demonstrate the usability" suggests comparison against accepted clinical interpretation or existing diagnostic standards, rather than pathology or long-term outcomes data primarily.
8. The Sample Size for the Training Set:
- The document does not specify a sample size for a training set. The descriptions focus on verification and validation testing, and on demonstrating functionality and equivalence. "Available patient data" is mentioned in the context of retrospective analysis for performance testing, not explicitly for training.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned and described, information on how its ground truth was established is not provided. The device in this submission is an update to a CT system's software functionality (specifically "FAST DE Results for TwinBeam Data"), rather than a new AI/CADx algorithm that requires extensive new training data in the context of this 510(k) summary. The focus is on demonstrating that the new software version performs as intended and is substantially equivalent to previous versions.
§ 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.