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K Number
K052904
Device Name
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
Manufacturer
SCIENTIFIC IMAGING, INC.
Date Cleared
2005-10-27

(13 days)

Product Code
JXE,JXF
Regulation Number
882.1550
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).

Device Description

Not Found

AI/ML Overview

This document appears to be an FDA 510(k) clearance letter for a medical device (Virtual Medical Systems VT 3000, a nerve conduction velocity measurement device). It does not contain the kind of detailed study information (acceptance criteria, performance data tables, sample sizes, ground truth establishment, expert qualifications, etc.) that would be part of a submission to demonstrate clinical effectiveness or safety as you've requested.

The document primarily focuses on:

  • Confirming substantial equivalence to a predicate device.
  • Indications for use (Nerve Conduction Studies and Evoked Potentials).
  • Regulatory classification (Class II).
  • General regulatory requirements for the manufacturer.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets them. The information you've requested typically comes from the detailed technical sections of the 510(k) submission itself, which are not included here.

The provided text does not contain any of the following information:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone performance analysis was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 882.1550 Nerve conduction velocity measurement device.

(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).