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K Number
K111259
Device Name
SV DBS VRAIN ARRAY
Manufacturer
MIDWEST RF, LLC
Date Cleared
2011-07-05

(62 days)

Product Code
MOS
Regulation Number
892.1000
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers.

Device Description

SV DBS Brain Array Model # 1500SV-GEMS64

AI/ML Overview

This section describes a 510(k) premarket notification for a medical device and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with acceptance criteria and reported performance metrics in the format of a typical clinical trial report.

Therefore, the requested information elements related to specific acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment are not explicitly provided in the given text.

The document primarily states:

  • Device Name: SV DBS Brain Array Model # 1500SV-GEMS64 (also referred to as SV Brain Array, Model # 1500SV-GE64 in the Indications for Use)
  • Regulation Number/Name: 21 CFR 892.1000, Magnetic resonance diagnostic device
  • Indications For Use: "The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers."

Summary of available information as per your request:

  1. Table of acceptance criteria and the reported device performance:

    • N/A. The document does not provide a table of acceptance criteria or specific performance metrics in terms of sensitivity, specificity, or other quantitative measures. The FDA's substantial equivalence determination implies that the device performs as safely and effectively as a legally marketed predicate device for its stated indications for use.

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

    • N/A. This information is not provided in the document.

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

    • N/A. This information is not provided in the document.

  4. Adjudication method for the test set:

    • N/A. This information is not provided 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:

    • N/A. This device is an MRI coil, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

    • N/A. This device is hardware (an MRI coil), not a standalone algorithm.

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

    • N/A. As this is an MRI coil, a ground truth in the context of diagnostic accuracy is not typically established for the device itself in the same way as an AI algorithm. Its performance is evaluated through image quality, signal-to-noise ratio, uniformity, etc., which are compared to the predicate device.

  8. The sample size for the training set:

    • N/A. This information is not provided in the document, as it's not an AI/algorithm-based device.

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

    • N/A. Not applicable, as this is an MRI coil, not an AI/algorithm-based device requiring a training set with established ground truth.

In summary, the provided document is an FDA 510(k) clearance letter for an MRI coil, which confirms substantial equivalence to a predicate device for specific imaging capabilities. It does not contain the detailed study results and performance metrics typically found in reports for AI-driven diagnostic software or clinical trials with specific acceptance criteria.

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.