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K Number
K092742
Device Name
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
Manufacturer
NEUSOFT MEDICAL SYSTEMS CO., LTD.
Date Cleared
2009-09-22

(14 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 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.