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The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

The CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of up to 2 slices simultaneously . The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

This document is a 510(k) summary for the Neusoft CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems. It establishes the substantial equivalence of these devices to a predicate device (CT-C3000 system, K020913).

However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is focused on regulatory compliance and establishing substantial equivalence based on the device's technical characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot extract the requested information. The document primarily describes:

• General Information: Trade name, common name, classification, manufacturer, and submitter details.
• Intended Uses: To produce cross-section images of the head and whole body by computer reconstruction of X-ray transmission data.
• Device Description: Whole-body X-ray computed tomography scanner with dual-slice capability, continuously rotating tube-detector system, and interactive software.
• Predicate Device: CT-C3000 system (K020913).
• Statement of Substantial Equivalence: Comparing the new devices to the predicate device in terms of type, standards compliance, and intended uses.
• FDA Approval Letter: Confirming the substantial equivalence determination.

To answer your specific questions, a different type of document (e.g., a clinical study report or a detailed performance and validation report) would be needed.

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The Superopen 0.23T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, MR Angiography, Imaging processing
Imaging capabilities: 2D, 3D Spin Echo( SE ), Short time inversion recovery (STIR), Fluid attenuated inversion recovery (FLAIR), 2D,3D Field Echo (FE), 2D, 3D Field Echo with Spoiler (FESP), 2D FESP Multi-Slice (FESP-MS), 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID), 2D, 3D Fast Spin Echo (FSE), 2D, 3D MRCP, MR Angiography, 2D, 3D TOF, MTC

The Superopen 0.23T is a 0.23T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

This document is a 510(k) summary for the Superopen 0.23T MRI System, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets them.

The document states that the device is "substantially equivalent" to a predicate device (NEUSOFT Superopen 0.35T, K030918) based on similarities in technology and intended uses. This means the FDA cleared the device not by requiring a study demonstrating it meets specific performance acceptance criteria, but by determining it is as safe and effective as a device already on the market.

Therefore, for each of your requested points, the answer is that the information is not provided in this 510(k) summary.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • Not provided. This document is a 510(k) summary demonstrating substantial equivalence, not a performance study report with specific acceptance criteria and detailed performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. The 510(k) process for this type of device often relies on demonstrating technical equivalence and similarity to a predicate, rather than new clinical trials with a test set of patient data.

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)

   • Not provided. Ground truth establishment for a test set is part of a clinical performance study, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not provided. Adjudication methods are relevant for studies involving human interpretation of results, which is not described.

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

   • Not provided. This document describes an MRI system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant or expected.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent to its scanning capabilities, which are deemed substantially equivalent to a predicate.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not provided. As no specific performance study against a ground truth is described, this information is absent.

8. The sample size for the training set

   • Not provided. Training set information is relevant for AI/machine learning models. This document describes an MRI system, which doesn't typically have a "training set" in that context. Its "training" would be its design, calibration, and engineering to meet technical specifications.

9. How the ground truth for the training set was established

   • Not provided. Similar to the point above, this is not applicable or detailed for an MRI system's substantial equivalence submission.

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The Superopen 0.35T is intended to produce images that reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Superopen 0.35T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Diffusion weighted imaging

MR Angiography

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:

Imaging capabilities:

Imaging processing 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D.3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion

The Superopen 0.35T is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or the details about sample sizes, expert involvement, and ground truth establishment typically found in a clinical performance study summary.

Instead, the document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) system (Superopen 0.35T) seeking substantial equivalence to a predicate device (Hitachi AIRIS II and its software).

Here's a breakdown of what the document does provide, and what it lacks in relation to the prompt's request:

Information Present in the Document:

1. Device Description and Intended Use: The document clearly outlines the Superopen 0.35T as a 0.35T permanent magnet MRI system intended to produce images for diagnostic purposes by trained physicians. It lists various imaging capabilities and anatomical regions.
2. Predicate Device: It identifies the Hitachi AIRIS II (K974212) and AIRIS II Version 4.1 Software (K001334) as the predicate devices for substantial equivalence.
3. Substantial Equivalence Statement: The Superopen 0.35T is deemed substantially equivalent based on similar technology, intended uses, and functional components (magnet system, gradient subsystem, RF subsystem, image reconstruction, etc.).
4. Regulatory Information: It includes CFR sections, classification name, product code, device class, applicable standards (IEC, DICOM, NEMA), and manufacturer details.

Information Not Present in the Document (and therefore, cannot be provided in response to the prompt):

• Acceptance Criteria Table and Reported Device Performance: There is no specific table defining performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) or acceptance thresholds. The document asserts substantial equivalence based on technical and functional similarity, not on a detailed performance study with defined criteria.
• Sample Sizes and Data Provenance for Test Set: No information is provided about a specific "test set" of images or patients used for performance evaluation. The substantial equivalence argument relies on the predicate device's established performance rather than a new clinical study.
• Number of Experts and Qualifications for Ground Truth: Since no independent performance study is detailed, there's no mention of experts establishing ground truth for a test set.
• Adjudication Method: Not applicable as there's no described performance study or ground truth establishment process involving multiple readers.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The submission is for a standalone imaging device, not an AI-assisted diagnostic tool.
• Standalone Performance (Algorithm Only): The device itself is a standalone MRI system, but the prompt's context usually refers to an algorithm's performance. There is no algorithm performance discussed in the AI sense.
• Type of Ground Truth Used: Not applicable in the context of a new performance study.
• Sample Size for Training Set: No information on a training set as this is a medical device submission based on substantial equivalence, not an AI algorithm development and validation.
• How Ground Truth for Training Set Was Established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Superopen 0.35T MRI system to existing legally marketed devices based on technological similarities and intended use. It does not present a clinical study with detailed acceptance criteria or performance metrics for the device itself. Therefore, I cannot construct the requested table or offer the detailed study information as it is not present in the provided text.

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CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

Not Found

This document is a 510(k) summary for the Neusoft CT-C3000 Spiral CT Scanner System. As such, it describes the device and its intended use but does not contain information about acceptance criteria or specific studies proving the device meets those criteria, nor details about ground truth, sample sizes, or expert adjudication for performance evaluation.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present novel clinical performance data meeting specific acceptance criteria.

The information provided only includes:

General Information about the Device:

• Trade Name: CT-C3000 Spiral CT Scanner System
• Common Name: CT Scanner
• Classification Name: Computed Tomography X-ray System (21 CFR Part 892.1750)
• Classification: Class II
• Performance Standard: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard; UL 187, Standard for safety, X-ray Equipment; IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.
• Manufacturer/Distributor: Neusoft Digital Medical System Co., Ltd.
• Indications for Use: CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

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