Search Results
Found 2 results
510(k) Data Aggregation
(166 days)
The NeuViz 128 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 128 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:0.374s、0.5s、0.6s、0.8s、1.0s、1.5s、2.0s.
- · Surview scan
- · Dual surview
- o Spiral scan
- o Axial scan
- Image reconstruction
- Plan scan
- Patient information management
- Patient information reqistration
- O Protocol selection
- Bolus Tracking
- CCT scan
- . Cardiac scan
- Multi-phase scan
- O Tube Warm-up
- Film
- Report
- O 2D
- DICOM Viewer O
- O MPR
- 0 3D
- Virtual Endoscopy
- . Dental
- Vessel Analysis
- Virtual Colonoscopy
- Brain Perfusion
- · Body Perfusion
- Lung Nodule Analysis
- Lung Density Analysis
- Coronary Analysis
- Cardiac Calcium Scoring
- Cardiac Function Analysis
- Cardiac Viewer
- Fat Analysis
- CTDSA
- Tumor Assessment
The provided text describes the NeuViz 128 Multi-Slice CT Scanner System (K151383), and its substantial equivalence claims against predicate devices. However, it does not contain detailed acceptance criteria for a specific device performance, nor does it present a study that explicitly details the device meeting such criteria with specific metrics.
The document focuses on non-clinical testing for compliance with various standards (electrical safety, EMC, radiation protection, usability, software lifecycle, risk management, DICOM) and states that "Verification and validation activities (including performance testing, safety testing and simulated use testing) are performed" and "The results of these tests demonstrate that the subject device performs as intended." It also mentions "Sample clinical images were provided within the submission. The image quality has been evaluated in bind state by two certified radiologists."
Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor fully answer all aspects of your request, as the specific performance metrics and detailed study results are not present.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The text states that the device adheres to various international and national standards (listed in the "Nonclinical Testing" section) and that "Verification and validation activities... are performed" and "The results of these tests demonstrate that the subject device performs as intended." However, specific numerical acceptance criteria (e.g., spatial resolution > X lp/cm, contrast resolution > Y HU) and corresponding reported performance values for the NeuViz 128 are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: "Sample clinical images were provided within the submission." The exact number of images or cases is not specified.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: "two certified radiologists."
- Qualifications of Experts: They are described as "certified radiologists." Further details on their experience level are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The term "adjudication method" is not explicitly mentioned. The document states that image quality was "evaluated in bind state by two certified radiologists," implying a consensus or independent review process, but the specific method (e.g., if one disagreed, what was the next step) is not detailed.
5. 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:
- MRMC Study: An MRMC comparative effectiveness study, particularly one comparing human readers with and without AI assistance, is not described or mentioned in the provided text. The device is a CT scanner, not an AI-powered diagnostic tool explicitly designed to assist human readers in a comparative effectiveness study as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the NeuViz 128 as a CT scanner system that performs image acquisition and reconstruction. While it has advanced image processing and visualization tools (e.g., "ClearView" iterative reconstruction, "Lung Nodule Analysis," "Cardiac Function Analysis"), the submission focuses on its performance as an imaging device. A "standalone" performance evaluation in the context of an algorithm replacing human interpretation is not explicitly described. The evaluation mentioned is of "image quality" evaluated by radiologists, suggesting human interpretation of the images produced by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the image quality evaluation appears to be the expert opinion/assessment of the two certified radiologists on the "sample clinical images." No mention of pathology, outcomes data, or other objective ground truths is included.
8. The sample size for the training set:
- Training Set Sample Size: The document does not mention a training set sample size. The device is a CT scanner, and while it uses algorithms for image reconstruction and analysis, the details of any machine learning training data are not provided in this 510(k) summary.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Since a training set is not mentioned, how its ground truth was established is also not provided.
Ask a specific question about this device
(160 days)
The NeuSight PET/CT Scanner System can be used for the functional and anatomical imaging of human bodies and organs. The device is intended for whole body or regional tumor examination, cardiac examination and head examination. The device can assist in radiotherapy planning and be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. Trained doctors can read useful diagnostic information from the image generated.
The NeuSight PET/CT Scanner System is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. It uses CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. NeuSight System has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. The product provide some reconstruct methods, such as FBP、3DRP、OSEM、 ClearView (cleared in K133373) , and some advance algorithms based on OSEM. These advance algorithms can improve the image quality.
The NeuSight PET/CT Scanner System consists of two variants:
- NeuSight PET/CT 64
- NeuSight PET/CT 16
NeuSight PET/CT 16 is designed based on NeuSight PET/CT 64 and has the same hardware configuration with NeuSight PET/CT 64. Their hardware of CT part is the same as NeuViz64 (K121792). In the performance parameters, NeuSight PET/CT 16 only limits the optional scope of partial scan parameters by software in order to different from NeuSight PET/CT 64. There's no essential technological difference between the two types of PET/CT and the safety and effectiveness of these products could be ensured through verification, validation and difference assessment.
The provided text describes the 510(k) summary for the NeuSight PET/CT 64 and NeuSight PET/CT 16 systems. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative form for device performance. Instead, it relies on substantial equivalence to a predicate device (GE Discover VCT System, K050559) and compliance with various international standards for safety and performance. The performance claim is that the device "performs as intended" and its image quality was "evaluated in a blind state by a certified radiologist."
While specific quantitative acceptance criteria are not provided in this summary, the general performance claims are:
| Metric / Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to the predicate device (GE Discover VCT System, K050559) in indications for use, operating principle, and scientific technology. Compliant with numerous international standards for safety and performance (e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 14971, NEMA NU2, NEMA PS 3.1 - 3.20, NEMA XR 25, NEMA XR 28). | "The results of these tests demonstrate that the subject device performs as intended." "The result of all conducted testing was found acceptable to support the claim of substantial equivalence." |
| Image Quality | Implicitly, image quality should be sufficient for diagnostic purposes, comparable to the predicate device, and acceptable to a certified radiologist. Compliance with NEMA NU2:2012 (Performance Measurements of Positron Emission Tomographs) and IEC 61223-3-5:2004 (Acceptance tests - Imaging performance of computed tomography X-ray equipment) implies adherence to established image quality standards. | "Sample clinical images were provided within the submission. The image quality has been evaluated in blind state by a certified radiologist." (No quantitative metrics are provided in this summary, only qualitative expert evaluation). |
| Safety and Harm | Compliant with Good Manufacturing Practices (GMP) 21CFR 820, ISO 13485:2003, and multiple safety-related standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60825-1). Risk management process (ISO 14971) implemented to minimize electrical, mechanical, and radiation hazards. Compliance with radiation safety performance standards (21 CFR §1010 and §1020). | "The safety and effectiveness of the NeuSight PET/CT Scanner System was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820 and to International Standards ISO 13485:2003." "Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled during product development, and verification and validation testing." |
| Software Performance | Compliant with IEC 62304:2006 (Medical device software - Software life-cycle processes) and FDA guidance for software in medical devices (Moderate Level of Concern). | "Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements if demonstrated via testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Sample clinical images were provided within the submission."
- Sample size: Not specified. It only mentions "sample clinical images."
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of experts: Singular, "a certified radiologist."
- Qualifications of experts: "certified radiologist." No further details like years of experience are provided in this summary.
4. Adjudication Method for the Test Set
The document states: "The image quality has been evaluated in blind state by a certified radiologist." This suggests a single reader evaluation. There is no mention of consensus or multi-reader adjudication methods (like 2+1 or 3+1).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not explicitly mentioned in this document. The evaluation of image quality was performed by a single certified radiologist. There is no information provided regarding human readers improving with AI vs. without AI assistance, as this is a PET/CT scanner system, not specifically an AI-driven image analysis tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This is a hardware device (PET/CT scanner) with integrated software for image reconstruction and display. The intent is "Trained doctors can read useful diagnostic information from the image generated." Therefore, the entire system is designed for human-in-the-loop performance. While the device contains "advance algorithms based on OSEM" that "can improve the image quality," the performance evaluation mentioned focuses on the output images read by a human. A standalone algorithm only performance, in the sense of an AI diagnostic tool without human review, is not described for this device.
7. The Type of Ground Truth Used
For the sample clinical images, the "ground truth" for evaluating image quality appears to be the expert opinion of a certified radiologist. There is no mention of pathology, outcome data, or expert consensus serving as ground truth for the image quality evaluation described.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This summary pertains to the regulatory submission for a PET/CT scanner system, not typically a machine learning algorithm that requires an explicit training set for its primary function. While it mentions "advance algorithms based on OSEM" that improve image quality, it does not describe their development or training data in this context.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also not applicable/provided in this document.
Ask a specific question about this device
Page 1 of 1