LogoFDA 510(k) Search
K Number
K053127
Device Name
IPLAN
Manufacturer
BRAINLAB, AG
Date Cleared
2006-02-09

(94 days)

Product Code
HAW
Regulation Number
882.4560
Type
Traditional
Panel
NE
Reference & Predicate Devices
K041703
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

iPlan's indications for use is to prepare and present patient and image data based on CT, MR, Xray(Fluoro), including

  • . image preparation
  • . image fusion
  • image segmentation .
    where the result is used for the creation of treatment plans for Stereotactic Surgery:
  • Surgery Planning
  • BrainMAP
  • Functional Planning
    In addition iPlan's indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro) including
  • . image preparation
  • . image fusion
  • image segmentation .
    where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:
  • Image Guided Surgery
  • FiberTracking
  • BOLD MRI
    iPlan BOLD MRI indication for use is to prepare image data based on BOLD (blood oxygen level dependent) MRI scan studies and display the result as parametric images. When interpreted by a trained physician or surgeon this information may be used with other anatomical information for planning and image guided surgery.
Device Description

The BrainLAB iPlan BOLD MRI module is software used for processing BOLD (blood oxygen level dependent) MRI sequences and display of calculation results. The slight MRI susceptibility changes between the images are visualized as parametric images.

AI/ML Overview

The provided document is a 510(k) summary for the iPlan BOLD MRI module, a software used for processing BOLD MRI sequences and displaying calculation results as parametric images. The document states that the device has been verified and validated according to BrainLAB's procedures, and that this validation "proves the safety and effectiveness of the system." However, it does not contain specific details about acceptance criteria, a formal study protocol, or performance metrics to demonstrate the device meets acceptance criteria. The approval is based on substantial equivalence to a predicate device (BrainLAB iPlan K041703).

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

Acceptance CriteriaReported Device Performance
Not specified in documentNot specified in document

2. Sample size used for the test set and the data provenance

  • Sample Size (Test Set): Not specified in the document.
  • Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

  • Number of Experts: Not specified in the document.
  • Qualifications of Experts: Not specified in the document. The document states that the information "may be used with other anatomical information for planning and image guided surgery" when interpreted by a "trained physician or surgeon," but this is an intended use statement, not a description of ground truth establishment for a study.

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

  • Not specified in the 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 specified in the document. The document focuses on the software processing and display, not a comparative effectiveness study with human readers assisted by AI.

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

  • The document implies a standalone performance (algorithm only) as it describes the software's ability to process BOLD MRI sequences and display results as parametric images. However, it does not provide specific performance metrics for this standalone function to prove it meets certain acceptance criteria. The assessment is based on verification and validation according to internal BrainLAB procedures.

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

  • Not specified in the document.

8. The sample size for the training set

  • Not specified in the document.

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

  • Not specified in the document.

Summary of what is present:

  • Device Name: iPlan BOLD MRI
  • Manufacturer: BrainLAB AG
  • Intended Use: To prepare image data based on BOLD MRI scan studies and display the result as parametric images. This information, when interpreted by a trained physician or surgeon, may be used with other anatomical information for planning and image-guided surgery.
  • Device Description: Software used for processing BOLD MRI sequences and displaying calculation results. Visualizes slight MRI susceptibility changes between images as parametric images.
  • Basis for Approval: Substantial equivalence to predicate device iPlan (K041703). The device underwent internal verification and validation procedures by BrainLAB to prove safety and effectiveness.

The 510(k) summary provides the regulatory and intended use context but lacks the detailed study results and performance metrics that would typically be found in a clinical trial report or a more comprehensive technical document.

§ 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).