FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

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.

Device Description

The Siemens SOMATOM Confidence is a Computed Tomography X- ray System which features one continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Confidence produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens 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 the post processing applications optionally.

The platform software for the SOMATOM Confidence, syngo CT VA62A (SOMARIS/7 VA62A), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Confidence will support the following modifications in comparison to the predicate devices:

1. New Marketing Name: SOMATOM Confidence (SOMATOM Confidence® RT Pro)
1. Modified Indication for Use Statement
1. New/Modified Hardware
- Touch Panels ●
- New Gantry and Patient Table Covers .
- Stellar RT Detector .
1. Software version SOMARIS/7 VA62A
- Data Exchange with external SW Client (Teamplay) ●
- IT Hardening .
- DirectDensity™ .
1. Update 510(k) Information

The SOMATOM Confidence will be offered in 20 and 64 slice configurations.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the comprehensive study results to populate all the requested fields for a specific AI device. The document is a 510(k) summary for a CT scanner (SOMATOM Confidence® RT Pro), which is a general imaging device, not an AI-powered diagnostic tool with specific performance metrics like sensitivity, specificity, or AUC related to an AI algorithm.

However, I can extract the information related to the device itself and its general performance verification, as well as the reference to a clinical trial relevant to one of its indications for use (low-dose lung cancer screening).

Here's a breakdown of what can and cannot be answered from the provided text:

Information directly available or inferable about the SOMATOM Confidence® RT Pro (CT System):

1. A table of acceptance criteria and the reported device performance: The document states that "all of the software specifications have met the acceptance criteria" and that "the testing results support that the requirement specifications have met the acceptance criteria" for the DirectDensity™ feature. However, the specific acceptance criteria values (e.g., specific signal-to-noise ratios, spatial resolution, CT number accuracy) and their corresponding reported performance values for the device itself (the CT scanner) are not presented in a table format within this summary. It generally assures conformity to performance standards like ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. For DirectDensity™, it mentions "image values proportional to relative electron density and perform as expected," but no quantitative criteria or performance figures are given.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the CT system's performance, including features like DirectDensity™. This is essentially a "standalone" evaluation of the imaging device's capabilities. There is no mention of an AI diagnostic algorithm being tested in a standalone capacity within this text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the testing of the CT system and its features such as DirectDensity™, phantom tests (using a Gammex 467 Tissue Characterization Phantom) and simulations were used.
8. The sample size for the training set: Not applicable for the CT scanner hardware/software itself. If this were an AI algorithm submission, this would be crucial.
9. How the ground truth for the training set was established: Not applicable for the CT scanner hardware/software itself.

Information related to the referenced "National Lung Screening Trial (NLST)" for the low-dose lung cancer screening indication:

2. Sample size used for the test set and the data provenance:
- Sample Size: The NLST was "a randomized trial of screening with the use of low-dose CT compared to chest radiography." While the exact number of participants is not given in this document, the referenced paper (N Engl J Med 2011; 365:395-409) is the primary source for this information. It is a prospective trial.
- Data Provenance: The trial was sponsored by the National Cancer Institute, implying multi-center US-based data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in this document, but would be detailed in the NLST publication. The interpretation task for CT in NLST was "to detect lung nodules of 4mm diameter or greater."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in this document for the NLST.
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: The NLST was a comparative effectiveness study comparing low-dose CT to chest radiography for lung cancer screening outcomes (mortality reduction). It was not specifically an MRMC study with AI assistance. It evaluated human readers interpreting images from two different modalities. The effect size reported by NLST was that screening with low-dose CT reduced lung cancer mortality compared to chest radiography. This document does not quantify that effect size but refers to the publication.

Summary Table:

Feature/Criterion	Acceptance Criteria (from text)	Reported Device Performance (from text)	Notes
CT System (SOMATOM Confidence® RT Pro)
General Performance	Conformance to ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. (Implicit: All software specifications meet acceptance criteria).	"All of the software specifications have met the acceptance criteria." "The test results show that all of the software specifications have met the acceptance criteria." "The data included in this submission demonstrates that the SOMATOM Confidence performs comparably to the predicate device that is currently marketed for the same intended use."	Specific quantitative criteria and performance values for the CT scanner (e.g., resolution, noise) are not explicitly detailed in this summary. General conformance to standards is stated.
DirectDensity™ Reconstruction	(Implicit: Requirement specifications for) "image values proportional to relative electron density and perform as expected."	"The results of verification and validation testing demonstrate that the subject device modifications for DirectDensity™ - image values proportional to relative electron density and perform as expected. The testing results support that the requirement specifications have met the acceptance criteria."	No quantitative metrics are provided for "proportional" or "as expected."
Electrical Safety & EMC	Conformance to IEC 60601-1, 60601-2-44, and 60601-1-2.	"Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM Confidence in accordance with the following standards." (Implicit: Conformed to these standards).	"Completed Form FDA 3654 are provided within this submission" indicates successful completion.
Cybersecurity	(Implicit: Implementation of) "process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient."	"Siemens conforms to the Cybersecurity requirements by implementing a process..."	Conformance to guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is stated.
Study for Low Dose Lung Cancer Screening Indication (Referenced NLST)	(Implicit: Demonstrate benefit of low-dose CT screening for lung cancer in high-risk populations).	NLST "was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer." "screening with low-dose CT could reduce mortality from lung cancer."	The specific effect size of mortality reduction is not quantified in this document, but the benefit is stated and refers to the NLST publication.

Additional Requested Information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For CT System Testing: Not explicitly specified (phantom tests, simulations).
- For NLST: Not explicitly stated in this document, but implied to be a large, prospective, multi-center US trial (National Cancer Institute sponsorship).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For CT System Testing: Not applicable (phantom/simulations).
- For NLST: Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For CT System Testing: Not applicable.
- For NLST: Not specified in this document.
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
- Not done with AI assistance. The NLST was a comparative effectiveness trial of two screening modalities (low-dose CT vs. chest radiography) interpreted by human readers. It did not involve AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, for the CT system itself. The performance of the SOMATOM Confidence CT system and its features (like DirectDensity™) were evaluated. This is not an AI diagnostic algorithm, but the imaging device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For CT System Testing: Phantom tests (Gammex 467 Tissue Characterization Phantom) and simulations.
- For NLST: Lung cancer mortality (outcomes data) was the primary endpoint. The "interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater" which would have likely been verified by pathology/follow-up.
8. The sample size for the training set
- Not applicable; this is for a CT system, not an AI algorithm requiring a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable.

Summary

Regulation Number and Section

§ 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.