(15 days)
The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data. For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both hardware and software components) will be offered and provides the following features: improved gantry tilt accuracy, reduced table top deflection, externally adjustable gantry laserlights, increased tube positioning accuracy, simplified horizontal positioning of the table, optimized field coverage using extended Field of View. Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.
A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following: Improved gantry tilt accuracy, Reduced table top deflection, Externally adjustable gantry laserlights, Increased x-ray tube positioning accuracy, Simplified horizontal positioning of the table, Optimized field coverage using extended Field of View (FOV).
This 510(k) summary (K042229) is for a "Radiation Treatment Planning (RTP) Package" for Siemens SOMATOM CT systems. It focuses on improving the geometric accuracy of anatomical data for radiation therapy.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of acceptance criteria or quantitative performance metrics for the device. Instead, it describes feature improvements intended to enhance geometric accuracy. The closest information to performance metrics are the qualitative improvements listed and one quantitative measurement for the "Simplified horizontal positioning of the table".
| Feature/Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Improved gantry tilt accuracy | The gantry tilt angle is displayed in 0.5-degree increments. |
| Reduced table-top deflection | Tabletop deflection is reduced by replacing the CT table, allowing for more accurate patient positioning. |
| Externally adjustable gantry laser lights | A position adjustment of the gantry laser lights is possible without opening the gantry, allowing easier installation and synchronization with room RTP lasers. |
| Increased x-ray tube positioning accuracy | The accuracy of x-ray tube positioning for Topogram scans is improved to a range of ± 2 degrees. |
| Simplified horizontal positioning of the table | During an examination, a table feed position can be stored, enabling fast and easy repositioning of a patient back to the previous table position (tolerance of ± 1 mm). |
| Optimized field coverage using extended Field of View (FOV) | The FOV is extended to 70 cm for maximum anatomical visualization and improved RTP positioning. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a test set sample size, country of origin of data, or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any experts used to establish ground truth or their qualifications. The device described appears to be a hardware/software upgrade to a CT system, and the "performance" described relates to the precision and physical capabilities of the system itself, rather than diagnostic accuracy that would typically require expert ground truth.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an accessory to a CT system focused on improving physical accuracy for radiation treatment planning, not an AI-based diagnostic tool requiring human-in-the-loop performance evaluation.
6. Standalone (Algorithm only without human-in-the-loop performance) Study:
A standalone study as typically understood for an algorithm's diagnostic performance was not conducted or reported. The performance metrics described relate to the physical accuracy of the CT system components, which would have been validated through engineering tests and measurements rather than a "standalone algorithm" study.
7. Type of Ground Truth Used:
The ground truth for this device's "performance" would likely be established through engineering measurements and calibration standards for physical accuracy (e.g., measuring gantry tilt with precise instruments, measuring table deflection under load, measuring laser alignment, and tube positioning with reference phantoms). The document does not explicitly state the type of ground truth used, but given the nature of the device, it would not be expert consensus, pathology, or outcomes data in the typical sense.
8. Sample Size for the Training Set:
The document does not mention or imply a training set sample size. This device is an upgrade to a CT system, not an AI model that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a "training set" or AI model in the conventional sense, the establishment of ground truth for a training set (or lack thereof) is not applicable to this submission.
§ 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.