(166 days)
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance.
Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering.
Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
The SCENARIA View system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
The provided document is a 510(k) premarket notification for the FUJIFILM SCENARIA View Computed Tomography x-ray system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (SCENARIA View K200498) rather than presenting a performance study for a novel AI device with specific acceptance criteria.
The document states: "A clinical evaluation comparison was conducted with the SCENARIA View system and the predicate device (K200498) and found to be substantially equivalent as documented in Section 10 - Performance." However, Section 10 - Performance is not included in the provided document. Without this section, detailed acceptance criteria and reported performance metrics from a specific study are not available.
The only specific performance testing mentioned with some detail is related to a new feature: "FUJIFILM has conducted an evaluation to assess the effectiveness of the images reconstructed by using MCR and a summary of the results is contained in an explanatory document in the Specification section." Again, this "explanatory document in the Specification section" is not provided. Therefore, a complete answer regarding acceptance criteria and performance based on a study is not possible from the given text.
Based on the available information, here's what can be inferred and what is missing:
No Specific Acceptance Criteria or Performance Study for a Novel AI Device is Fully Described in the Provided Text.
The document is a 510(k) submission for a CT system, emphasizing substantial equivalence to a previous version of the same system (SCENARIA View K200498). The primary "study" mentioned is a clinical evaluation comparison to the predicate device and an evaluation of a new feature called Motion Compensate Reconstruction (MCR). While the document asserts these evaluations were conducted and support substantial equivalence, the details of the acceptance criteria and the results of these studies are not present.
The document indicates that comprehensive performance data for the CT system (Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index) were evaluated and found to be unchanged or comparable to the predicate device. However, specific "acceptance criteria" and "reported device performance" in a tabular format are not provided for these metrics, nor are the studies detailing these.
Regarding the MCR feature: The document states that "FUJIFILM has conducted an evaluation to assess the effectiveness of the images reconstructed by using MCR and a summary of the results is contained in an explanatory document in the Specification section." This suggests a study was performed, but its details, acceptance criteria, and specific performance outcomes are not shared in the provided pages.
Based on what is explicitly stated or can be strongly inferred about the evaluation of the MCR feature (as this is the only new "feature" with an explicit "evaluation" mentioned), here's an attempt to answer the questions, highlighting the significant gaps in information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for MCR, as inferred) | Reported Device Performance (for MCR, as stated) |
|---|---|
| Details not provided in the document. Would likely relate to reduction of motion artifacts or improvement in image quality. | "effectively reduces motion image" (implied from the purpose of MCR) |
| "effectiveness of the images reconstructed by using MCR" was assessed. |
(Note: Without "Section 10 - Performance" and the "explanatory document in the Specification section," the actual acceptance criteria and detailed performance metrics are unavailable.)
2. Sample Size for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified in the provided document for the MCR evaluation or the clinical evaluation comparison.
- Data Provenance: Not specified for any evaluation or data used. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. The document does not mention the use of experts to establish a ground truth for any evaluation, including the MCR feature.
4. Adjudication Method:
- Not specified. No information is given about how findings or image quality assessments were adjudicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not explicitly mentioned. The document primarily focuses on technical comparisons and the effectiveness of a new reconstruction algorithm (MCR) in image quality. It does not describe a study comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
- The MCR feature is an "image reconstruction feature that reduces motion artifacts." This inherently implies an algorithm-only function. However, a formal "standalone performance" study with specific metrics (e.g., accuracy, sensitivity, specificity for identifying or correcting motion) is not described. The evaluation mentioned is about assessing the "effectiveness of the images reconstructed by using MCR," which could refer to qualitative or quantitative image quality assessment.
7. Type of Ground Truth Used:
- Not specified. For the MCR evaluation, the ground truth would ideally involve images with known motion artifacts and/or comparison to a higher-fidelity scan if motion was absent. However, this is not detailed in the document. For the overall system, typical CT performance metrics are evaluated against industry standards and physical phantoms.
8. Sample Size for the Training Set:
- Not applicable as this is a CT system with a new reconstruction algorithm (MCR), not a deep learning AI model requiring a distinct "training set" in the common sense for AI diagnostics. MCR is likely based on image processing and reconstruction physics, not machine learning that learns from a vast training dataset in the same way a diagnostic AI would.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reasons as #8.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a CT scanner. It mentions evaluations for new features (like MCR) and overall system performance compared to a predicate device. However, it does not contain the detailed reports, acceptance criteria, or quantitative results of these studies that would typically be expected for a comprehensive answer regarding acceptance criteria and device performance. The key missing pieces are "Section 10 - Performance" and the "explanatory document in the Specification section" that supposedly contain these details.
§ 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.