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K Number
K053017
Device Name
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
Manufacturer
INVIVO CORPORATION
Date Cleared
2005-11-16

(21 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 shoulder that can be interpreted by a trained physician.

Device Description

Models HRS-63-8 and HRS-127-8 Shoulder Array Coils

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (MRI coils). This type of document does not contain information regarding software-related acceptance criteria, study details, or AI performance metrics.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements for the physical device, but it does not include any performance data or studies that would address the points in your request related to acceptance criteria for software, AI, or human reader performance.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, number of experts for ground truth, or adjudication methods for a test set.
  3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
  4. Type of ground truth used.
  5. Sample size for the training set or how its ground truth was established.

§ 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.