(86 days)
The Somatom Plus 4 with Volume Zoom package is 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 angels 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 Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner 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.
The Siemens Somatom Plus 4 with Volume Zoom package is a CT scanner, and the provided documentation focuses on its substantial equivalence to existing CT systems rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/CADe devices. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, effect size, etc.) is not applicable or available in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device meets Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33. | The device is designed to meet the stated standards. |
| Safety: Device meets ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1, +A1:1991, +A2:1995, and IEC 60601-1-2. | The device is designed to meet the stated standards. |
| Intended Use: 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. | The device is a whole-body X-ray computed tomography scanner used for whole body X-ray computed imaging. |
| Technological Equivalence: Substantially equivalent to Siemens SOMATOM Plus 4, GE CT/I, Elscint Twin Flash, and SOMATOM Plus 4 Power systems in commercial distribution. | (Implicit) The FDA's 510(k) clearance signifies acceptance of substantial equivalence, meaning the device performs similarly to predicate devices. Specific performance metrics (e.g., image resolution, dose, scan speed) are not explicitly provided in this summary but would have been part of the technical documentation reviewed by the FDA for substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission is for a new feature (Volume Zoom package) on an existing CT scanner, demonstrating substantial equivalence to other CT scanners. It's not a performance study of a diagnostic algorithm based on a test dataset of patient cases. The evaluation is focused on technical specifications and adherence to existing CT standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. See point 2.
4. Adjudication method for the test set
- Not applicable. See point 2.
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. This is a CT scanner, not an AI/CADe device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a CT scanner, not a standalone algorithm.
7. The type of ground truth used
- Not applicable (in the context of clinical performance data). The "ground truth" here is compliance with technical standards and performance characteristics of existing CT scanners for demonstrating substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. 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.