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The NeuViz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

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The provided document is a 510(k) clearance letter from the FDA for the "NeuViz 16 Multi-Slice CT Scanner System." This type of document declares substantial equivalence to a predicate device based on performance specifications and safety, but does not typically contain detailed information about a clinical study with acceptance criteria, sample sizes, expert adjudication, or AI performance metrics.

Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria, study details, and AI performance. The document focuses on regulatory clearance, not on a detailed clinical performance study report.

To answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in this document. This document is a regulatory clearance letter, not a performance study report.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
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 available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
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 available in this document. This device is a CT scanner, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. This device is a CT scanner, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

In summary, the provided document is a regulatory decision letter and does not contain the detailed technical and clinical study information you are asking for regarding a device's performance against specific acceptance criteria or an AI-related study.

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The Neu Viz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

The NeuViz 16 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 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 software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

The provided text is a 510(k) summary for the NeuViz 16 Multi-slice CT Scanner System. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance from a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, or training set details.

The document focuses on demonstrating that the NeuViz 16 is substantially equivalent to the Philips Brilliance CT16 Scanner System (K012009) based on:

• Intended Use: Both are whole-body computed tomography X-ray systems with multislice capabilities.
• Device Description: Both use similar materials, construction, operating principles (continuously rotating X-ray tube and detector array, fan beam principle), and software for acquisition, reconstruction, and archive/evaluation.
• Performance Standards: Adherence to various IEC and CFR standards for medical electrical equipment, radiation protection, and CT-specific requirements.
• Safety Assurance: Conformance to Good Manufacturing Practices (GMP), ISO 13485:2003, hazard analysis, software safety procedures, and electrical/mechanical safety standards (IEC 60601-1 series).

In essence, the "study" proving the device meets acceptance criteria in this context is the submission and FDA's acceptance of the argument for substantial equivalence, supported by technical specifications and adherence to recognized standards, rather than a clinical performance study with specific metrics.

Therefore, I cannot populate the requested table or answer the specific questions about clinical study design as the provided text pertains to a regulatory submission for substantial equivalence based on technical comparisons and standards compliance, not a clinical performance study.

Ask a specific question about this device