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This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

• As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011;365:395-409) and subsequent literature, for further information.

The SOMATOM Edge Plus systems are multi-slice X-Ray Computed Tomography scanners.

The device produces 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.

These systems are intended to be utilized by appropriately trained health care professionals. Typical uses of the systems include neurology, oncology and cardiology in standard practice as well as in trauma or emergency situations. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and simulation, as well as during interventional radiology procedures.

Each SOMATOM Edge Plus consists of a 78 cm bore size gantry (including mechanical and electrical components), a patient handling system (PHS) that moves the patient into and out of the gantry during the scans (various beds can be paired with this system), a Power Distribution Cabinet (PDC) and an Image Management System (comprised of various computers).

The SOMATOM Edge Plus software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The SOMATOM Edge Plus is based on the commercially available SOMATOM Definition Edge system (K152036). The software (VB10) has been updated to incorporate additional features as well as provide updates for workflow and anomaly corrections as compared to the predicate device. Key changes compared to the primary predicate include:

• Updated X-Ray Tube
• Tin Filter Technology
• Touch Panel Controls
• Improvements to patient positioning
• Updated computers due to obsolescence
• Updates to software to add improved features and functionality
• Inclusion of the features available on other SOMATOM CT systems such as SOMATOM Drive (K161196) and SOMATOM Confidence (K162302)
• HD FoV Improvements
• CARE and FAST feature improvements
• kV and Filter Independent CaScore

The SOMATOM Edge Plus consists of the following key specifications:

| Feature | SOMATOM Edge Plus
Subject Device |
|------------------------------------|----------------------------------------|
| Patient Port Diameter | 78 cm |
| Tilt | +/- 30 degrees |
| Scan times Full Scan | 0.28, 0.33, 0.5, 1.0 s |
| # Ranges / protocol | 33 |
| Sliding Gantry Travel Range | 12 m |
| Max Scan Range | 2000 mm |
| Tube Assembly | Straton MX Sigma |
| Tube current | 20 - 800 mA |
| Tube Voltages | 70, 80, 90, 100, 110, 120, 130, 140 kV |
| DMS Technology | Stellar Infinity |
| Number of Rows | 64 |
| Max number of slices /
rotation | 128 |
| FAST 3D Camera | Yes |
| Touch Panel Controls | YES |
| Iterative Reconstruction | SAFIRE, ADMIRE, iMAR |
| Tin Filter Technology | Yes |

The provided text does not contain the details of a study proving the device meets acceptance criteria related to AI/algorithm performance, nor does it list specific acceptance criteria for such a study.

The document is a 510(k) Premarket Notification for a CT system (SOMATOM Edge Plus). It focuses on demonstrating substantial equivalence to previously marketed CT systems based on hardware changes, software updates for workflow and anomaly corrections, and adherence to established medical device standards (e.g., IEC, NEMA for electrical, mechanical, and radiation safety, and basic software development).

Instead of an AI/algorithm performance study, the document describes:

• Indications for Use: The system generates and processes cross-sectional images for aid in diagnosis, treatment preparation, and radiation therapy planning, including low-dose lung cancer screening.
• Performance Testing/Safety and Effectiveness: This section primarily discusses compliance with safety standards (IEC, FDA regulations for radiation, electrical, mechanical hazards), risk management (ISO 14971), and cybersecurity.
• Verification, Validation, and Performance testing: This refers to standard engineering validation, ensuring the device functions as intended and performance is comparable to predicate devices in terms of image acquisition, reconstruction, and basic system operation, not AI-driven diagnostic performance metrics.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving device meeting those criteria in the context of AI/algorithm performance, multi-reader multi-case studies, or standalone algorithm performance, as these topics are not addressed in the provided text.

The text generally states: "Performance testing met the predetermined acceptance values," and "The successful verification and validation testing demonstrates that the SOMATOM Edge Plus functions as intended and that performance is comparable to the predicate devices." However, these "acceptance values" are not detailed in terms of specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI or algorithm.

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