(136 days)
SOMATOM Emotion 6/16 CT 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.)
The SOMATOM Emotion 6 and the SOMATOM Emotion 16 are whole body X-ray Computed Tomography Systems. The SOMATOM Emotion 6 and the SOMATOM Emotion 16 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, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports the following modifications: 1) Localized language support of scan protocols, 2) Easy UI improvement, 3) Study Split Improvement, 4) FAST kV, 5) syngo. via client, 6) online help based on knowledge gateway, 7) new software field update concept 8) Temporal-MIP, 9) TrueD-4D viewer, 10) FAST 3D Align, 11) Tube Protection.
Here's a breakdown of the requested information, based on the provided document. It's important to note that this document is a 510(k) summary for a CT scanner's software update, not an AI/CADe device. Therefore, many standard AI/CADe study components (like expert ground truth establishment, MRMC studies, and effect sizes) are not explicitly detailed in the way they would be for an AI device. The focus here is on the system's performance and safety.
Acceptance Criteria and Device Performance for SOMATOM Emotion 6/16 (syngo® CT VC30-easyIQ version)
The document primarily relies on non-clinical testing and conformance to international standards to demonstrate substantial equivalence to predicate devices, rather than a specific set of acceptance criteria tied to clinical endpoints with a test set of patient data. The "acceptance criteria" are implicitly the device's ability to meet the requirements of the listed standards and perform its intended functions without introducing new risks or compromising image quality/safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Derived from standards/claims) | Reported Device Performance (Summary from doc) |
|---|---|---|
| Device Safety & Electrical Compatibility | Conformance to IEC 60601 series (safety, radiation protection) | Designed to fulfill requirements of IEC 60601-2-44, IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6. Risk analysis completed, risk control implemented. |
| Image Quality & Performance | Conformance to IEC 61223 (evaluation & routine testing of imaging performance) and NEMA XR-25/29 (dose) | Designed to fulfill requirements of IEC 61223-3-5, IEC 61223-2-6. Performance data demonstrates continued conformance. Non-clinical tests conducted during product development; modifications supported with verification/validation testing. |
| Software Functionality & Reliability | Conformance to IEC 62304 (medical device software life cycle processes), FDA Software Guidance (Moderate Level of Concern) | Designed to fulfill requirements of IEC 62304. Software Documentation for a Moderate Level of Concern per FDA guidance included. Testing results support that all software specifications have met the acceptance criteria. Verification/validation testing found acceptable. The software supports listed modifications (e.g., Localized language support, Easy UI improvement, Study Split Improvement, FAST kV, syngo.via client, Online help, etc.) as intended. |
| Data Format & Interoperability | Conformance to NEMA PS 3.1 - 3.14 (DICOM) | Designed to fulfill requirements of NEMA PS 3.1 - 3.14. Produces CT images in DICOM format. |
| Risk Management | Conformance to ISO 14971 (application of risk management) | Risk analysis completed and risk control implemented to mitigate identified hazards. |
| Substantial Equivalence (Overall) | Comparable intended use, indications for use, technological characteristics (image acquisition, operating platform, image manipulation) to predicate devices. No new safety/effectiveness concerns. | Has the same intended use and comparable indication for use as predicate devices. Technological characteristics are similar to predicate devices. Non-clinical performance data and software validation demonstrate the subject device is as safe and effective. Testing results found acceptable to support the claim of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the sense of a distinct dataset of patient scans used for evaluating clinical performance of an AI model. Instead, it refers to:
- Non-clinical tests: These were conducted during product development to verify and validate the software modifications. The document does not specify the sample size of these tests (e.g., number of test cases, simulated data, phantom scans).
- Data Provenance: Not applicable as there is no mention of a specific patient data test set. The document indicates that the predicate devices were cleared based on "non-clinical supportive information and clinical images," but these are not for the subject device's testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document as it is not a study evaluating an AI/CADe system using expert-labeled ground truth patient data. The ground truth for this device's performance is established through adherence to engineering standards and functional testing, not clinical expert consensus on patient images.
4. Adjudication Method for the Test Set
This information is not provided as there is no described clinical test set with adjudicated ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, an MRMC comparative effectiveness study was not explicitly mentioned or described. This document is a 510(k) summary for a CT scanner's software update, not an AI-assisted reading device that would typically undergo such a study. The focus is on demonstrating that the updated software does not alter the fundamental safety or effectiveness of the CT system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a CT scanner, which inherently involves human operation. Its "performance" is evaluated against engineering standards and its functional specifications, not as a standalone diagnostic algorithm in the way an AI would be. So, while independent component testing would have occurred, it's not "standalone algorithm performance" in the typical AI/CADe sense.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Standards and Specifications: Adherence to international standards (IEC, NEMA, ISO) for CT systems, software, and risk management.
- Functional Requirements: The new software features (e.g., FAST kV, Temporal-MIP, Easy UI improvement) perform as designed and intended.
- Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This document describes a software update for a CT scanner, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided as there is no machine learning model or training set 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.