(21 days)
The SOMATOM Emotion 6 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 Siemens SOMATOM Emotion 6 systems are a whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
This document is a 510(k) summary for the Siemens SOMATOM Emotion 6 Computed Tomography X-ray System. It focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study to prove meeting detailed acceptance criteria for a new device's performance.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be fully answered from the provided text because these elements are typically part of a performance study demonstrating novel functionality or a new medical claim, which is not the primary purpose of this 510(k) submission.
However, I can extract and infer some information based on the context of a 510(k) for a CT scanner.
1. Table of acceptance criteria and the reported device performance:
Since this is a submission demonstrating substantial equivalence of a new model of an existing device type (CT scanner), the "acceptance criteria" are implicitly met by demonstrating that the device performs at least as well as and no worse than the predicate devices in terms of its fundamental technical characteristics and safety. The document does not provide specific quantitative performance metrics comparing the SOMATOM Emotion 6 to predicate devices.
| Acceptance Criteria Category | Reported Device Performance (as inferred from document) |
|---|---|
| Intended Use Equivalence | "The SOMATOM Emotion 6 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." This is stated as equivalent to predicate devices. |
| Technological Characteristics Equivalence | "The SOMATOM Emotion 6 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Emotion systems... The system will operate with SOMARIS/5 software." Stated as substantially equivalent to Siemens SOMATOM Emotion Duo and Somatom Sensation 4 CT scanners. |
| Safety Standards Compliance | "All components... certified to meet those requirements [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33]... designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY." |
| Performance Standard | Meets 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. This document does not detail a clinical performance study using a test set of patient data, but rather focuses on technical specifications and safety standards for demonstrating substantial equivalence.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set with human-established ground truth is described. The "ground truth" here is the established performance and safety profile of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No MRMC study is mentioned. This device is a CT scanner, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a CT imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k), the "ground truth" is primarily implicit: the established safety, effectiveness, and technical performance of the predicate devices (Siemens SOMATOM Emotion Duo and Somatom Sensation 4 CT scanners). The substantial equivalence claim is based on the new device having similar fundamental technology and meeting the same safety and performance standards as these already legally marketed devices.
8. The sample size for the training set:
- Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.