(140 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 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 text describes a 510(k) premarket notification for the Hitachi SCENARIA View computed tomography x-ray system (K200498). However, it focuses heavily on demonstrating substantial equivalence to a predicate device (SCENARIA View K190841) rather than detailing specific acceptance criteria and a study proving those criteria are met for this new iteration of the device, especially concerning any new AI features.
The document does mention two new features: "Volume Shuttle Scan" and "HiMAR Plus," and a "clinical image study to assess the image quality of the images reconstructed by using FBP and the two new features (HiMAR Plus, Intelli IPV)." It's unclear if "Intelli IPV" is a typo for "Volume Shuttle Scan" or another unmentioned feature.
Given the information provided, I cannot fully answer all aspects of your request as the document does not contain explicit acceptance criteria and detailed study results in the format you've requested for the new features. It primarily states that the overall device performance is "similar to the predicate device" and that "evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device."
Here's an attempt to organize the available information based on your request, with significant gaps noted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative manner for new features or a direct comparison to specific performance metrics for the subject device (K200498) against pre-defined thresholds. Instead, it relies on demonstrating comparability to a predicate device (K190841) and general compliance with standards.
For the overall system, the document states:
- "This device complies with all applicable requirements for Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index."
- "The evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device."
For the new features (HiMAR Plus, Volume Shuttle Scan, and potentially Intelli IPV), specific acceptance criteria and their met performance are not detailed. The phrase "clinical image study to assess the image quality of the images reconstructed by using FBP and the two new features" implies an evaluation, but the results or acceptance criteria for this evaluation are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical image study" for the new features. However, it does not provide any specific information on:
- Sample size (number of images or patients) used for this test set.
- Data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It briefly notes a "clinical evaluation comparison was conducted with the SCENARIA View system and the SCENARIA Phase 3 System (K150595) and found to be substantially equivalent," but this appears to be a general comparison of overall system performance rather than a specific MRMC study involving human readers with/without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not specify if a standalone performance study was conducted. The mentioned "clinical image study" likely involves subjective evaluation of reconstructed images, which could imply a standalone assessment of image quality, but details are lacking.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for the "clinical image study." Given the context of image quality assessment for new CT reconstruction features, the ground truth would likely be based on:
- Expert Consensus: Radiologist interpretation of image quality parameters.
- Physical Phantoms: Quantitative measurements using known phantom properties (though this tends to be more for technical performance aspects like noise and spatial resolution rather than a "clinical image study").
The document mentions evaluations for "dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index," which would typically use physical phantoms. However, the "clinical image study" for "image quality of the images reconstructed by using FBP and the two new features" suggests a different type of assessment.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is expected as the document describes a CT system (hardware and associated software features) rather than a deep learning AI model that typically requires extensive training data. The "new features" like HiMAR Plus (HItachi's Metal Artifact Reduction) are often based on algorithmic improvements rather than learned models from large datasets.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of typical AI/ML development, this information is not applicable/provided.
Summary of Gaps:
The FDA 510(k) summary provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing specific, quantitative acceptance criteria and the rigorous testing (especially for any AI components) that would fully answer your questions. While it mentions new features and a clinical image study, critical details such as sample sizes, expert qualifications, and specific results are absent in this public summary. These details would typically be found in the full submission to the FDA.
§ 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.