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K Number
K033619
Device Name
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2004-03-02

(105 days)

Product Code
HAW
Regulation Number
882.4560
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Unibody Fiducial Marker System." This type of letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics and is considered as safe and effective.

However, a 510(k) clearance does not typically include the detailed acceptance criteria or the specific study results proving those criteria were met in the way a clinical trial report or a comprehensive technical document would. The FDA letter is a regulatory approval document, not a scientific publication of study findings.

Therefore,Based on the provided document, the following information cannot be extracted:

  • A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" but does not define specific performance metrics or acceptance criteria, nor does it report the device's performance against them.
  • Sample size used for the test set and the data provenance: No information about a test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) is provided.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not mention any ground truth establishment for a test set or the involvement of experts for this purpose.
  • Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information is available regarding an adjudication method.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a physical "Fiducial Marker System," not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance is not applicable and not mentioned.
  • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a physical medical device, not an algorithm, a standalone performance study in this context is not relevant and not mentioned.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information about ground truth is provided.
  • The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
  • How the ground truth for the training set was established: Not applicable, as there's no training set mentioned.

The document's primary purpose is to grant regulatory clearance by establishing substantial equivalence to a predicate device, not to detail specific performance studies or their methodologies.

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).