(227 days)
The NeuViz 16 Essence Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
The NeuViz 16 Essence Multi-Slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data.
The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools:
- Support following scan speed: 0.5s、0.6s、0.75s、1.0s、1.5s、2.0s.
- · Surview scan
- Dual surview
- · Spiral scan
- Axial scan
- Image reconstruction
- Plan scan
- Patient information management
- Patient information registration
- Protocol selection
- O-Dose
- . Bolus tracking
- SAS
- Home
- Film
- Report
- 2D
- MPR
- 3D
- VE(Virtual Endoscopy)
- Vessel Analysis
- Dicom Viewer
- · Bar code Reader
- Dual Monitor
- Continuous CT
- ClearView
- Dental Analysis
- Virtual Colonoscopy
- Brain Perfusion
- Body Perfusion
- Lung Nodule Analysis
This document describes the Neusoft Medical Systems NeuViz 16 Essence Multi-Slice CT Scanner System (K171198). The information provided focuses on the substantial equivalence claim to its predicate devices, K092742 (NeuViz 16 Multi-Slice CT Scanner System) and K151383 (NeuViz 128 Multi-Slice CT Scanner System).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of quantitative acceptance criteria for image quality metrics or a direct comparison of measured performance against specific thresholds. Instead, it states that "The clinical validation was executed as planned and acceptance criteria met for each requirement." It also mentions that "The Results indicated that the images were of diagnostic quality."
For image quality, the document states:
"Some of the bench tests included the sag and the speed of patient support table, the gantry wobble, CT image quality metrics testing including CT number accuracy and uniformity, MTF, noise, slice sensitivity profiles and CTDI." It also states, "Sample images were provided to show the performance of the system in presence of implants."
The conclusions state: "The results of these tests demonstrate that the subject device performs as intended." and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
The document indicates that a clinical validation was performed, which included "image evaluation...to evaluate images of the brain, chest, abdomen and spine/extremities of the body area." However, it does not specify the sample size (number of patients or images) used for this test set nor the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document mentions that "An image evaluation was performed...Images were scored using a 5 point Likert scale by a qualified radiologist." This indicates that one qualified radiologist was used for ground truth assessment. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed beyond "qualified radiologist."
4. Adjudication Method for the Test Set:
Based on the information provided, it appears that no specific adjudication method (like 2+1 or 3+1) was used, as only one radiologist is mentioned for scoring the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human reader improvement with or without AI assistance. The study focuses on demonstrating the diagnostic quality of the images produced by the device.
6. Standalone Performance Study:
The information provided describes the performance of the "NeuViz 16 Essence Multi-Slice CT Scanner System" as a standalone medical device capable of image acquisition and reconstruction. The clinical validation assessed whether the images produced by the device were of diagnostic quality. Therefore, a standalone performance assessment (device only, without human interpretation for improving diagnostic accuracy) was implicitly performed in that the output of the device (the images) was evaluated for its diagnostic utility. The study doesn't contrast with a human-in-the-loop scenario.
7. Type of Ground Truth Used:
The ground truth for the clinical validation was established through expert consensus/reader evaluation. Specifically, "Images were scored using a 5 point Likert scale by a qualified radiologist," who determined if the images were of "diagnostic quality."
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size of a training set. The descriptions focus on the validation of the device and its algorithms (FBP, ClearView), not on the training data for an AI model. "ClearView" is mentioned as an iterative reconstruction algorithm cleared in K133373, but no details about its training data are given in this K171198 submission.
9. How the Ground Truth for the Training Set Was Established:
Since no information is provided about a training set for an AI model, there is no information on how its ground truth would have been established. The "ClearView" algorithm, where potentially AI/machine learning could be involved, references a previous 510(k) (K133373), and the current document does not detail its development or training.
§ 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.