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K Number
K022488
Device Name
MODEL OBC-63 BREAST ARRAY COIL
Manufacturer
MRI DEVICES CORP.
Date Cleared
2002-08-23

(25 days)

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

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Device Description

Model OBC-63 Breast Array Coil

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Model OBC-63 Breast Array Coil." It primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, this document does not contain the information needed to describe acceptance criteria and a study proving a device meets them. It is a regulatory clearance, not a performance study report.

Specifically, the following information is not present in the provided document:

  1. A table of acceptance criteria and the reported device performance: The document does not define any specific performance metrics or acceptance criteria for the device, nor does it report any performance data.
  2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of ground truth establishment or expert involvement in a study.
  4. Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
  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: This device is a breast array coil for MRI, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
  6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: This pertains to algorithm performance, which is not relevant for a physical MRI coil.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is discussed.
  8. The sample size for the training set: Not applicable for a physical device.
  9. How the ground truth for the training set was established: Not applicable for a physical device.

The document only states the device's indications for use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician." This indicates its intended purpose but does not specify performance parameters or how those are met.

§ 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.