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The Motion Correction System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system is a sensorbased technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner for further data processing.

User: Professional Use

Environment: Hospital, doctor's office, or any facility that uses an MRI device

KinetiCor defines the Motion Correction System as an accessory to a medical device. It is intended to supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.

Device Description

During an MRI scan, if the patient's head does not remain still during the scan, the resulting images may not be sharp. This could prevent a physician from analyzing the images, therefore requiring additional scanning.

Software has been developed to somewhat reduce these effects.

KinetiCor has developed a Motion Correction technology using a track the true position of the patient's head. These coordinates are provided to the MRI scanner, which adjusts the MR images.

The Motion Correction System delivers head pose tracking and correction in 6 degrees of freedom for MR applications.

. Optimized for high field MR environments, the technology has been FDA Cleared for use in the MAGNETOM Vida, 510(k) K183254, cleared January 18, 2019. Customized optics, electronics and enclosures minimize Electromagnetic Interference (EMI) and Radiofrequency (RF) interference and isolate the camera system for stable tracking accuracy.
. Proprietary optical machine vision tracking technology provides tracking data to the MRI scanner with a static accuracy of approximately 0.1 mm and 0.1 deg. This means that the MR pulse sequences are updated in real-time.
The impact of the Motion Correction technology can be illustrated by taking a closer look at the corrected and uncorrected images in the figure below.

The Motion Correction System Hardware consists of the following:

Camera Enclosure (incorporating four Cameras) located inside the distal end of the MRI scanner; ●
Wiring Conduit - provides a protected location for wiring to exit the distal end of the MRI scanner;
Processing Unit - electronics with software, located outside the MRI room;
External Wiring - used to connect processing unit to Camera Enclosure;
. Tracking Markers - single use markers located on patient nose bridge (Referred to as "Nose Marker for Inline Motion Correction" in predicate device);
External Monitor - if requested, located inside MRI Control Room;
Network System located outside the MRI room.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the KinetiCor Motion Correction System (K193324) based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a reported device performance table in the typical format of a clinical study outcome. Instead, it describes the technology's performance capabilities and its substantial equivalence to a predicate device.

However, based on the description, we can infer some performance claims:

Acceptance Criteria (Inferred from device description)	Reported Device Performance (From device description)
Static Tracking Accuracy (position)	Approximately 0.1 mm
Static Tracking Accuracy (angle/degrees of freedom)	Approximately 0.1 deg (for 6 degrees of freedom)
Real-time update of MR pulse sequences	MR pulse sequences are updated in real-time based on tracking data
Ability to correct for patient head motion	Motion correction using KinetiCor technology results in sharper MR images
Equivalence to predicate device for motion correction	Provides the same motion correction hardware and technology as the predicate device
Safety and Effectiveness	Device is safe, as effective, and performs as well as or better than the predicate device

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for a test set in terms of patient numbers or a dataset size for evaluating device performance. The non-clinical tests mention "Software Verification and Validation testing" and "Design Verification and Validation testing" but don't provide details on the data used.
Data Provenance: The document does not specify the country of origin of data or whether it was retrospective or prospective for any performance evaluation directly linked to the KinetiCor Motion Correction System. The comparative images (corrected vs. uncorrected MRI scans) are presented as illustrative examples, not as part of a formal study with specified provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts, their qualifications, or how ground truth was established by experts for a specific test set. The visual comparison of "corrected" and "uncorrected" images implies a qualitative assessment of image quality, but this isn't attributed to a formal expert review process with specified criteria or adjudicators.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is a motion correction system directly influencing image quality, rather than an AI diagnostic aid that assists human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance assessment was effectively done for the core function of the motion correction system, though not presented as a formal study in the typical sense of a diagnostic algorithm. The description states:

"Proprietary optical machine vision tracking technology provides tracking data to the MRI scanner with a static accuracy of approximately 0.1 mm and 0.1 deg."
"The MR pulse sequences are updated in real-time."
The comparison of "Motion correction using KinetiCor technology" versus "MR images obtained when the motion was not corrected" (Figure on page 5) directly illustrates the system's performance in isolation from human interpretation. The effectiveness is demonstrated by the improved image quality produced by the system itself.

7. Type of Ground Truth Used

The ground truth for the motion correction capabilities appears to be based on:

Quantitative measurements: The stated static accuracy of 0.1 mm and 0.1 deg implies a technical measurement against a known, precise reference or standard for validating the tracking technology.
Visual comparison/Qualitative assessment: The "corrected" versus "uncorrected" image examples serve as a qualitative ground truth demonstrating the visual improvement in image quality due to the system's function. The "similar motion performed during both scans" indicates a control for comparing the effect of the system.
The device is framed as an accessory to improve image quality, and its "effectiveness" is linked to this improvement, rather than a diagnostic outcome for which pathology or outcomes data would be the ground truth.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. It mentions "Proprietary optical machine vision tracking technology," which implies algorithms that might have been trained, but no details are provided.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established.

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