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510(k) Data Aggregation
(15 days)
SOMATOM P30 CT SYSTEMS
The SOMATOM P30 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 P30 is a whole body X-ray computed tomography systems, 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 provided document, a 510(k) summary for the SOMATOM P30 CT System, does not contain details about specific acceptance criteria or a study proving the device meets them, in the typical sense of a performance study for AI/CAD-like devices.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Plus 4 with Volume Zoom (K982349)) and adherence to regulatory standards for medical imaging equipment.
Therefore, many of the requested sections about specific performance studies (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) cannot be extracted from this document, as they are not present.
Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory requirements and substantial equivalence) | Reported Device Performance (As stated in the document) |
|---|---|
| Safety: | |
| Meets Federal Diagnostic Equipment Performance Standard (21 CFR Subchapter J) | "All components...are certified to meet those requirements; and a product report as per 21 CFR § 1002.10 will be filed..." |
| Meets 21 CFR § 1020.30 and § 1020.33 (Diagnostic X-ray systems) | "All components...are certified to meet those requirements..." |
| Meets ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1 | "The SOMATOM P30 is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1" |
| Meets UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY | "The SOMATOM P30 is designed to meet...UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY." |
| Effectiveness (Imaging Capability): | |
| Produce cross-sectional images of the body | "The SOMATOM P30 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data..." |
| Function according to fan beam principle | "features a continuously rotating tube-detector system and functions according to the fan beam principle." |
| Perform patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation | "The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation." |
| Substantially equivalent in design, material composition, energy source, and radiation characteristics to predicate device | "the SOMATOM P30 systems operating with SOMARIS/5 "syngo" software are substantially equivalent to the predicate device Siemens SOMATOM Plus 4 with Volume Zoom (K982349)" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not mentioned. This document does not describe a clinical performance study using a test set of patient data, as would be typical for AI/CAD devices. The focus is on hardware and software system safety and functional equivalence to an existing CT system.
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)
- Not applicable / Not mentioned. As no clinical performance study involving a test set and ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not mentioned. No adjudication method is described as there is no test set or expert ground truth determination.
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 document describes a CT scanner, not an AI or CAD device intended to assist human readers, so an MRMC study is not relevant and was not performed/described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not mentioned. This is a CT imaging system. Its "performance" is inherent in its ability to produce images, not in an algorithmic diagnostic output that would be evaluated in a standalone manner like an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not mentioned. Ground truth in the context of clinical accuracy is not discussed here, as the submission focuses on regulatory compliance and functional equivalence, not diagnostic accuracy studies.
8. The sample size for the training set
- Not applicable / Not mentioned. The device is a CT scanner, not an AI algorithm trained on a dataset. The software performs image reconstruction and management, likely based on established algorithms and engineering, not machine learning from a "training set" of images in the typical AI sense.
9. How the ground truth for the training set was established
- Not applicable / Not mentioned. As there's no mention of a training set, there's no ground truth establishment for it.
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