(134 days)
The SCENARIA View 4.2 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 quidance. 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 FUJIFILM Healthcare Corporation.
The SCENARIA View 4.2 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 4.20system 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 4.2 system consists of a Gantry, Operator's Workstation, Patient Table, High- Frequency X-ray Generator, and accessories.
Here's a breakdown of the acceptance criteria and study information for the Scenaria View 4.2 CT system, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of document often relies on comparative analysis and verification that new features do not negatively impact existing performance, rather than extensive clinical efficacy studies for the entire device. For a CT Scanner, the primary acceptance criteria revolve around image quality, dose, and safety, often demonstrated through bench testing and compliance with recognized standards.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Image Quality & Dose | Dose Profile | Evaluated, no change from the predicate device. Compliance with applicable requirements. |
| Image Noise | Evaluated, no change from the predicate device. Compliance with applicable requirements for Noise, Mean CT number and Uniformity. | |
| Modulation Transfer Function (MTF) / Spatial Resolution | Evaluated, no change from the predicate device. Compliance with applicable requirements for Spatial Resolution. | |
| Slice Thickness and Sensitivity Profile | Evaluated, no change from the predicate device. Compliance with applicable requirements for Tomographic Section Thickness and Sensitivity Profile. | |
| Slice Plane Location / Tomographic Plane Location | Evaluated, no change from the predicate device. Compliance with applicable requirements. | |
| CT Dose Index | Evaluated, no change from the predicate device. Compliance with applicable requirements. | |
| System Functionality | AutoPositioning Function | Verified working correctly through system testing. Various cases were tested to verify it shows up as an option. All test results performed as expected (installed, version info, enable, prohibit when not installed). |
| ExamSplit Function | Verified and validated to work as expected. A mock procedure confirmed the following: |
- Automatic analysis queue for main recon of original inspection registered and executed.
- Automatic analysis queue for original inspection multi-recon registered and executed after multi-recon.
- Automatic analysis queue for PES registered and executed after Exam Split.
- Exam Split starts after scan, Multi Recon starts after recon completion. All testing passed. |
| Safety & Standards | Compliance with: - AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012. C1:2009/(R)2012 and . A2:2010/(R)2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Conformance demonstrated. |
| | - IEC 60601-1-2 Edition 4.0 (Electromagnetic compatibility) | Conformance demonstrated. |
| | - IEC 60601-1-3 Edition 2.1 (Radiation protection in diagnostic X-ray equipment) | Conformance demonstrated. |
| | - IEC 60601-2-44 Edition 3.2 (Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography) | Conformance demonstrated. |
| | - IEC 62304 Edition 1.1 (Medical device software - Software life cycle processes) | Conformance demonstrated. |
| | - NEMA XR 25 (Computed Tomography Dose Check) | Conformance demonstrated. |
| Technological Equivalence| Features (Tilt for helical scan, improved Exam Split, AutoPositioning) do not impact safety and effectiveness compared to the predicate device, and the subject device is substantially equivalent to the predicate device (K213829). | Thorough analysis and comparison conducted. Technological characteristics (e.g., SSD for image storage, new features) do not impact safety and effectiveness. |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify a numerical "sample size" in terms of patient cases for testing.
- The performance evaluations for image quality and dose (Dose Profile, Noise, MTF, Slice Thickness, CT dose index, etc.) are described as "Performance Testing - Bench." This typically involves phantom studies or specified calibration procedures rather than patient data.
- For the new software features (AutoPositioning, ExamSplit), testing involved "various cases" and "mock procedure," which are likely internal verification and validation tests rather than tests on a diverse patient dataset.
- Data Provenance: Not explicitly stated as retrospective or prospective patient data, but the descriptions strongly suggest bench testing with phantoms/test objects or internal system validation using mock scenarios/simulated data. No country of origin for patient data is mentioned as no clinical studies with patient data were detailed for the new features.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. For performance testing on a CT scanner, ground truth is usually established through physical measurements, calibration standards, and technical specifications, rather than expert interpretation of images for diagnosis. For the software features, the "ground truth" was whether the feature performed as designed based on the functional requirements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None is explicitly mentioned. The testing described (bench tests, functional verification) does not typically involve human adjudication in the way clinical studies for diagnostic accuracy would.
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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 MRMC comparative effectiveness study was done or described. The device is a CT imaging system, and while it has a "Low Dose CT Lung Cancer Screening Option," the submission discusses the system's performance and new software features like AutoPositioning and ExamSplit, not a specific AI-assisted diagnostic tool. There is no mention of AI assistance for human readers or any effect size related to reader improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes the performance of the CT system and its software features. The "Low Dose CT Lung Cancer Screening Option" is an indication of use for the system, not a separate standalone algorithm whose performance is being evaluated independently. The new features (AutoPositioning, ExamSplit) are functionalities of the CT system itself, not standalone algorithms for diagnosis. The performance testing is focused on the system's technical specifications and the correct functioning of these features. Therefore, this question is not directly applicable in the context of the information provided for this CT device's 510(k).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For image quality and dose metrics (Dose Profile, Noise, MTF, etc.), the ground truth is established by physical measurements, standardized phantoms, and adherence to technical specifications and industry standards.
- For the new software features (AutoPositioning, ExamSplit), the ground truth was the pre-defined functional requirements and expected system behavior.
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The sample size for the training set:
- This information is not provided as the document describes a CT imaging system and its software features, not a machine learning or AI model that requires a dedicated training set for diagnostic purposes described in the output. The software features mentioned (AutoPositioning, ExamSplit) are likely rule-based or algorithmic improvements, not deep learning models.
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How the ground truth for the training set was established:
- This information is not provided and is not applicable given the absence of a stated training set for a machine learning or AI algorithm.
§ 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.