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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 proposed 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.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of improvements over Filtered Back Projection (FBP) reconstruction. It does not explicitly state pre-defined "acceptance criteria" with numerical thresholds that the device must meet, but rather reports the observed performance improvements from the testing. The "acceptance criteria" are implied to be achieving demonstrably equivalent or better diagnostic image quality and performance compared to FBP, particularly with dose reduction and improved image characteristics.

2. Sample Size for the Test Set and Data Provenance

• "ClearInfinity" Performance Verification (Quantitative):

  • Sample Size: Not explicitly stated as "test set" for the quantitative phantom studies. These are engineering bench tests using raw datasets.
  • Data Provenance: Raw datasets obtained on NeuViz 128. Implied to be internal testing.

• "ClearInfinity" Clinical Image Evaluation (Reader Study):

  • Sample Size:
    • 30 retrospectively collected clinical cases (for normal dose comparison).
    • 20 retrospectively collected clinical cases (for simulated low dose comparison).
  • Data Provenance: Retrospectively collected clinical cases.
    • For general performance claims, the document states: "US patient-based testing data for ClearInfinity collected from three sites of OK and one site of TX, a total of 445 clinical cases of 297 independent patients." It's unclear if these 445 cases directly constitute the raw data for the specific 30 and 20 cases in the reader study, or a larger pool from which they were selected.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• "ClearInfinity" Clinical Image Evaluation (Reader Study):
  • Number of Experts: 3 board-certified radiologists.
  • Qualifications: "board-certified radiologists." No specific years of experience are provided.

4. Adjudication Method

• "ClearInfinity" Clinical Image Evaluation (Reader Study):
  • The document states: "Each image was read by 3 board-certified radiologists who provided an assessment of image quality related to diagnostic use according to a 5-point Likert scale." It does not specify an adjudication method (like 2+1 or 3+1) if there were disagreements among the readers. It implies individual assessments were aggregated or used to determine the overall conclusion of equivalence or betterment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Yes, a reader study was performed for "ClearInfinity."
• Effect Size: The document states that the results "indicate that ClearInfinity is equivalent or better than Filtered Back Projection in diagnostic quality" for both normal and low-dose cases. It does not provide a specific quantitative effect size (e.g., AUC improvement, percentage increase in concordance) for how much human readers improve with AI assistance. It focuses on the comparative diagnostic quality of images produced by ClearInfinity versus FBP.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Yes, standalone performance was extensively evaluated through "Engineering bench testing" using phantoms. This included quantitative measurements of:
  • Dose reduction capability
  • Low-contrast detectability improvement
  • Image noise reduction
  • Spatial resolution improvement (for ClearInfinity)

7. Type of Ground Truth Used

• Engineering Bench Testing (Phantom Studies): For quantitative metrics, the "ground truth" is established by the known properties of the phantoms (CCT189 and CCT191 MITAIQ LC Phantoms, QA phantom water layer, high-contrast test device) and objective measurements using methods like the channelized Hotelling observer.
• Clinical Image Evaluation (Reader Study): The "ground truth" for diagnostic quality was established by the expert consensus/assessment of 3 board-certified radiologists using a 5-point Likert scale, comparing images reconstructed with FBP and ClearInfinity from the same raw data.

8. Sample Size for the Training Set

• Training Set for ClearInfinity: The document lists "US patient-based testing data for ClearInfinity collected from three sites of OK and one site of TX, a total of 445 clinical cases of 297 independent patients" as performance verification data. It also states ClearInfinity uses a "trained deep learning neural network." However, it does not explicitly state that these 445 cases were used as the training set. It's common for regulatory submissions to mention a larger pool of data used for development/testing, but the specific training set size is not detailed here.

9. How the Ground Truth for the Training Set Was Established

• The document mentions "a trained deep learning neural network" for ClearInfinity but does not describe how the ground truth for this training set was established. This information is typically proprietary and part of the manufacturer's internal development process for the AI algorithm.

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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.

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