(159 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.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are whole body X-ray computed tomography scanners which operate with SOMARIS/5 software. SOMARIS/5 is a windows based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are able to transfer the acquired CT image data for image evaluation, using the DICOM standard.
New software version syngo® CT VC28 supports the addition of eCockpit, eStart, eMode, eSleep, a Table Footswitch, Adaptive Signal Boost, and Gantry tilt Speed up.
The provided text describes a 510(k) premarket notification for the Siemens SOMATOM Scope and SOMATOM Scope Power computed tomography (CT) x-ray systems. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards.
However, the document does not contain any information about acceptance criteria, reported device performance in relation to those criteria, or the details of a study that would prove the device meets specific performance acceptance criteria related to a diagnostic task or algorithm performance.
The document details:
- Substantial Equivalence: It claims the device is substantially equivalent to predicate devices (SOMATOM Emotion 16 and SOMATOM Spirit) based on similar intended use and fundamental scientific technology.
- Device Description: It describes the CT systems and new software features (eCockpit, eStart, eMode, eSleep, Table Footswitch, Gantry tilt Speed up, IRIS, Adaptive Signal Boost) which primarily focus on operational efficiency, tube life extension, and image reconstruction techniques.
- Technical Characteristics Comparison: A table compares technical specifications between the subject devices and predicate devices, showing some differences in generator output, anode heat storage, and scan times, among others.
- Nonclinical Testing: It lists various international standards (ISO, IEC, NEMA) that the device is designed to fulfill, covering risk management, electrical safety, software life cycle processes, DICOM, and evaluation/testing of CT equipment performance. It states that non-clinical and phantom testing were conducted, and a risk analysis was completed. It mentions that testing results support "all the software specifications have met the acceptance criteria," and "verification/validation testing" was done.
Below is a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria for a diagnostic task or a detailed report of device performance against such criteria. It mentions compliance with various technical standards and states that "all the software specifications have met the acceptance criteria" from non-clinical and phantom testing, but these specific criteria and their quantitative results are not detailed. The technical characteristics comparison table serves to show equivalence in hardware specifications rather than performance against a clinical acceptance criterion.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided. The document refers to "non-clinical tests and phantom testing" but does not specify the sample size of cases/images used in a test set, nor the provenance (e.g., country of origin, retrospective/prospective) of any clinical data that might have been used for testing a diagnostic algorithm's performance. Since the device described is a CT scanner, rather than an AI-powered diagnostic algorithm, such clinical test sets for specific diagnostic tasks are typically not part of the initial 510(k) for the hardware itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. As no clinical test set for a diagnostic algorithm is detailed, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided.
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
This information is not provided. The document describes a CT system and its software features, some of which relate to image reconstruction (IRIS) or signal enhancement (Adaptive Signal Boost), but it does not mention any AI assistance or MRMC studies evaluating clinical reader performance with or without such assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a CT scanner, not a standalone diagnostic algorithm. While some software features (like IRIS) process data, the document does not present them as a standalone diagnostic algorithm with performance metrics.
7. The Type of Ground Truth Used
This information is not provided. For non-clinical and phantom testing, the "ground truth" would typically refer to known physical properties of the phantoms or calibrated measurements, but details are absent.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe the development or training of any specific AI algorithm that would require a training set. The software updates mentioned primarily enhance the scanner's operational efficiency and basic image processing.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See point 8).
§ 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.