(133 days)
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations*. *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:
SOMATOM go. Platform CT scanner systems:
- . SOMATOM go.Up
- . SOMATOM go.Now
- SOMATOM go.All
- SOMATOM go.Top
- . SOMATOM go.Sim
- . SOMATOM go.Open Pro
SOMATOM X. Platform CT scanner systems:
- . SOMATOM X.cite
- . SOMATOM X.ceed
In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.
The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
The platform software for the SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray scan control, image reconstruction, and image archive/evaluation.
The software platform provides plugin software interfaces that allow for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.
New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.
Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.
The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.
The provided text is a 510(k) summary for a Computed Tomography (CT) system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing and comparison of technological characteristics. The document does not contain information about comparative effectiveness studies, multi-reader multi-case (MRMC) studies, or detailed clinical study results with ground truth establishment as one might find for a novel AI/ML-driven diagnostic device.
Therefore, many of the requested items (e.g., sample size for the test set, number of experts, adjudication methods, MRMC study effect size, training set details) are not explicitly mentioned in this type of submission. The focus here is on the CT system itself and its software updates, not on a new AI algorithm for detection or diagnosis where such detailed performance metrics against ground truth would be paramount.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria & Reported Device Performance
The document describes "bench testing" as non-clinical supportive testing for specific features. The acceptance criteria are generally qualitative (e.g., "comparable accuracy," "reduce the number of alignment artefacts," "successfully detect needle-tips") rather than specific numerical thresholds.
| Feature / Non-clinical Supportive Testing | Acceptance Criteria (Implicit from Objectives) | Reported Device Performance (Test Results) |
|---|---|---|
| FAST 3D Camera / FAST Integrated Workflow | Accuracy of FAST Isocentering, FAST Range, and FAST Direction comparable to predicate device (syngo CT VA40) with old camera hardware and ceiling mount. | FAST Isocentering: Comparable accuracy to predicate, regardless of camera mounting. |
| FAST Range: Detection accuracy of body region boundaries comparable. (Note: Legs can be occluded by torso in gantry mounting, not severe limitation as leg exams are usually feet-first). | ||
| FAST Direction: Pose detection results comparable accuracy. | ||
| Overall: SOMARIS/10 syngo CT VB10 delivers comparable accuracy to predicate for new FAST 3D Camera hardware, also in new gantry position. | ||
| Multi-Purpose Table | Sufficient freedom of movement for a mobile C-arm X-ray system for clinical routine without significant limitations for myNeedle Lasers or FAST 3D Camera when installed with enhanced distance (674 mm) to CT gantry and offering iCT mode functionality. | Technical feasibility and possible limitations evaluated. Concluded that the CT scanner with a Multi-Purpose (Vitus) Patient Table, enhanced distance (674 mm) and iCT mode, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations. |
| Direct Breathhold | A spiral scan can be automatically triggered from an external respiratory gating device, with the actual scan remaining unchanged and the object correctly depicted. | Test results showed a spiral scan can be automatically triggered, actual scan remains unchanged, and object is correctly depicted. |
| ZeeFree | Reduce number of artifacts attributed to stack misalignment; no new artifacts introduced; equivalent image quality in quantitative standard physics phantom-based measurements (noise, homogeneity, high-contrast resolution, slice thickness, CNR); equivalent image quality in quantitative and qualitative phantom-based measurements for metal objects; algorithm successfully applied to phantom data demonstrating correct technical function; algorithm independent from physical detector width. | If misalignment artifacts identified, "Cardiac Stack Artefact Correction" (ZeeFree) enables optional stack artifact corrected images which reduce number of alignment artifacts. Does not introduce new artifacts. Realizes equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR. Realizes equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects. Successfully applied to phantom data from a motion phantom. Independent from physical detector width. |
| myNeedle Guide (with myNeedle Detection) | Clinical usability of the needle detection algorithm, accuracy of automatic needle detection, reduction of necessary user interactions for navigating to a needle-oriented view. | Algorithm consistently detected needle-tips in 90.76% of cases over a wide variety of scans. Auto needle detection functionality reduces the number of interaction steps needed to generate a needle-aligned view. With successful AI-based needle tip detection, no user interaction is needed to achieve needle-aligned view during needle progression (manual adjustment always possible). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the individual feature tests. The tests refer to "phantom tests" and "analysis of phantom images". For "myNeedle Guide," it mentions "a wide variety of scans," but no specific number.
- Data Provenance: The document does not specify the country of origin for the test data (phantoms) or if any retrospective/prospective human data was used. Given the nature of these tests (bench testing on phantoms), human patient data is generally not the primary focus for these types of technical evaluations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided as the testing primarily involves technical and phantom-based evaluations, not clinical reader studies requiring expert ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/provided as detailed clinical studies with reader adjudication are not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical testing and feature comparison, not on quantifying improvement in human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- For the "myNeedle Guide" feature, the 90.76% detection rate of needle tips might be considered a form of standalone performance for that specific algorithmic component, though it's still being evaluated in the context of aiding a human user. For other features, the tests are primarily system-level or component-level functional checks.
7. The Type of Ground Truth Used
- For the non-clinical tests described, the "ground truth" would be established through phantom specifications and controlled experimental setups with known parameters (e.g., precise needle location in a phantom, known artifact presence/absence in a reconstructed image). This is typical for engineering verification and validation testing for CT systems.
- For the "myNeedle Guide," the "ground truth" for needle tip detection would likely be based on the known, true location of the needle tip within the phantom or experimental setup.
8. The Sample Size for the Training Set
- This information is not provided. The document describes software updates and system features, not the development of a new AI model from a training set. If the "myNeedle Guide" used machine learning, its training set details are not described here.
9. How the Ground Truth for the Training Set was Established
- This information is not provided as no training sets are explicitly described.
§ 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.