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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:

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.

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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.

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