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K Number
K223875
Device Name
MOBINEURO Alita Intraoperative MRI System
Manufacturer
Sino Canada Health Engineering Research Institute (Hefei)
Date Cleared
2023-03-20

(87 days)

Product Code
LNH
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 MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body.

The MOBINEURO Alita Intraoperative MRI System is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:

  1. Correspond to the distribution of protons exhibiting MR characteristics;

  2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and

  3. Display the soft tissue structure of the body.

When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.

The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.

Device Description

Not Found

AI/ML Overview

There is no information present in the provided document about the acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) clearance letter for the MOBINEURO Alita Intraoperative MRI System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any details regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts used to establish ground truth.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or associated effect sizes.
  6. Whether a standalone (algorithm only) performance study was conducted.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, and lists its Indications for Use. It does not delve into the specific performance studies and criteria that would typically be described in a clinical study report or a more detailed section of the 510(k) submission.

§ 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.