(170 days)
The iCT device with sliding gantry 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 angles or spiral planes* taken at different angles.
(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).
iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements.
iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.
Here's a breakdown of the acceptance criteria and study information for the iCT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from predicate) | Reported iCT Performance |
|---|---|---|
| Image Quality | To perform to the same image quality specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package (K081022 & K032475). | Meets Criteria: "Image quality testing based on high precision phantoms was provided in this submission to demonstrate substantial equivalence with the predicate." and "iCT has been tested to perform to the same image quality... specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package." |
| Z-axis Accuracy | To perform to the same z-axis accuracy specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package (K081022 & K032475). | Meets Criteria: "...iCT has been tested to perform to the same... z-axis accuracy... specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package." |
| Gantry Stability | To perform to the same gantry stability specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package (K081022 & K032475). | Meets Criteria: "...iCT has been tested to perform to the same... gantry stability specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package." |
| Product Safety Standards | To conform to applicable product safety standards. | Meets Criteria: "iCT has also been tested to conform to applicable product safety standards." and "iCT meets the applicable requirements of the Federal performance standards for ionizing radiation emitting products defined in 21 CFR §§1020.30 and 1020.33 for CT systems. It conforms to the applicable International Electrotechnical Commission (IEC) 60601 family of standards... iCT complies with NEMA XR-25, Computed Tomography Dose Check." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This implies that clinical images were NOT used as a test set. The testing was done using "high precision phantoms." The specific number of phantoms or scans performed is not provided.
- Data Provenance: Not applicable, as clinical data was not used for the test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as the testing was conducted using "high precision phantoms" and laboratory studies, not clinical data and expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable, as the testing was conducted using "high precision phantoms" and laboratory studies, not human evaluation of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This indicates the evaluation was technical and mechanical, not clinical or involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the primary evaluation was a standalone technical/mechanical evaluation of the iCT system's performance metrics (image quality, z-axis accuracy, gantry stability) against the specifications of the predicate device using phantoms. This is effectively a "standalone" assessment of the device's physical and image acquisition capabilities without human interpretation of clinical images.
7. The Type of Ground Truth Used
- The ground truth was established by the specifications and performance characteristics of the predicate device, specifically the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. The iCT's performance was measured against these established technical benchmarks using "high precision phantoms."
8. The Sample Size for the Training Set
- Not applicable. The iCT is leveraging a previously cleared CT gantry, power supply and operator console components (SOMATOM Definition, Model AS/AS+), including its syngo software platform and compatible syngo applications. The iCT itself is primarily a modification concerning the physical mounting and movement of this existing CT technology (ceiling rails vs. floor rails). Therefore, it doesn't appear to involve its own separate "training set" in the context of an AI/algorithm. The core imaging algorithms are assumed to be from the predicate device.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as a separate training set for the iCT's distinct features (ceiling mounted gantry movement) is not described, and the core imaging software/algorithms are inherited from the cleared predicate device. The information provided focuses on the physical and technical performance of the modified gantry system.
§ 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.