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K Number
K040349
Device Name
MODIFICATION TO HRW-127 WRIST ARRAY COIL
Manufacturer
MRI DEVICES CORP.
Date Cleared
2004-03-09

(26 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 wrist and hand that can be interpreted by a trained physician.

Device Description

Model HRW-127 Wrist Array Coil

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Model HRW-127 Wrist Array Coil." This letter confirms that the device is "substantially equivalent" to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be found in a submission dossier or a scientific publication. The FDA letter is the result of the review process, not the detailed content of the review itself.

Therefore, based solely on the provided text, I cannot answer most of your questions as the information is not present.

Here's what I can and cannot infer from the given text:

What can be inferred from the text:

  • Device Name: Model HRW-127 Wrist Array Coil
  • Regulation Number: 21 CFR 892.1000 (Magnetic resonance diagnostic device)
  • Regulatory Class: II
  • Product Code: 90 MOS
  • Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician."
  • Type of Use: Prescription Use
  • 510(k) Number: K040349
  • Clearance Date: March 9, 2004

What cannot be inferred from the text (and why):

  1. A table of acceptance criteria and the reported device performance: This information would be in the device manufacturer's 510(k) submission, not the FDA clearance letter. The letter simply states that the FDA found the device "substantially equivalent."
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. 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: This device is a "Wrist Array Coil," which is hardware for an MRI scanner. It's not an AI algorithm. Therefore, an MRMC study comparing human readers with/without AI assistance is not applicable to this type of device.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
  8. The sample size for the training set: Not mentioned (and likely not applicable in the same way an AI model has a "training set," as this is a hardware device).
  9. How the ground truth for the training set was established: Not mentioned.

To get the answers to these questions, you would need to access the original 510(k) submission documentation for K040349, which often contains performance data, bench testing results, and potentially clinical data depending on the device and predicate. This information is typically proprietary or only available in heavily redacted forms through FOIA requests.

§ 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.