RESTGRID PACKAGE/GYROSCAN NT by PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 3'P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

RestGrid is a software option available for the Gyroscar-NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV.

RestGrid applies regional saturation of magnetization to the tissue. The saturation is spatially modulated resulting in a series of equally spaced saturation lines or bands. Deformation of the saturation pattern is used to evaluate regional cardiac motion or blood flow.

AI/ML Overview

Here's an analysis of the provided text regarding the RestGrid package, extracting information related to acceptance criteria and supporting studies:

This submission (K982834) describes the RestGrid package / GYROSCAN NT, a software option for Philips Gyroscan NT and Gyroscan CV Magnetic Resonance Imaging (MRI) systems. The core function of RestGrid is to apply regional saturation of magnetization to tissue, creating spatially modulated saturation lines or bands. The deformation of these patterns is then used to evaluate regional cardiac motion or blood flow.

It's important to note that this 510(k) summary does not detail specific performance studies with quantitative acceptance criteria against clinically defined ground truth. Instead, the demonstration of safety and effectiveness relies on substantial equivalence to previously cleared devices and adherence to established safety standards for MRI systems.

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are predominantly related to the device's functional equivalence to predicate devices and its compliance with general MRI safety standards, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) derived from a clinical study.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	The device should be capable of evaluating regional heart wall motion and blood flow in a non-invasive study.	The RestGrid Option is stated to be "used to evaluate regional heart wall motion and blood flow in a non-invasive study." (This is a statement of capability rather than a measured performance against a clinical gold standard).
Technological Equivalence	The technological characteristics for creating spatially modulated saturation lines/bands should be consistent with predicate devices or established MRI principles.	"The technological characteristics remain identical to other Gyroscan NT systems. Spatially modulated saturation of the magnetization of the tissue is introduced for imposing the patterns of saturation lines." (Implies the underlying technology is not novel in a way that would introduce new risks or performance issues beyond existing systems).
Safety Parameters	The safety parameters of the MRI system with the RestGrid option should remain within the limits of FDA cleared Gyroscan NT systems and relevant FDA guidance documents for MRI. Specifically, adherence to:FDA cleared Gyroscan NT systems (ref.K963990)"Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application"Draft "MRI Guidance Update for dB/dt dd. 10-11-'95"NEMA voluntary standardsUL and IEC 601 relevant safety standards and/or draft standards	"The safety parameters of the MR systems remain the same as with the FDA cleared Gyroscan NT systems (re.K963990) and within the limits of the FDA documents: 'Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application' and draft 'MRI Guidance Update for dB/dt dd. 10-11-'95'." (This is a declaration of compliance based on the existing system's clearance and adherence to standards, not a new safety study specifically for RestGrid).
Substantial Equivalence	The device should be substantially equivalent to predicate devices for saturation techniques in MRI, specifically:RestSlab technique Gyroscan NT (ref.K.980645)Cardiac Tagging Techniques / Magnetom Vision (ref.K973799)	Philips "believes the RestGrid Software Package to be substantially equivalent to saturation techniques applied in commercially available RestSlabs (FDA re.K980645) and to Siemens Cardiac Tagging (FDA re.K973799)." (This is the primary argument for clearance, not a result of a direct comparative study within this submission).

Study Information (Based on Provided Text)

The provided 510(k) summary does not describe a specific clinical performance study with a test set, ground truth, or expert review process as typically understood for AI/CADe devices. Instead, the submission relies on the concept of substantial equivalence to existing, legally marketed predicate devices and compliance with established MRI safety and performance standards.

Therefore, many of the requested categories related to clinical study design cannot be answered from this document.

Sample size used for the test set and the data provenance: Not applicable, no specific clinical test set described. The submission relies on the established performance and safety of predicate devices and the underlying Gyroscan NT systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no described test set requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no test set described.
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: Not applicable. This device is a new software feature for an existing MRI system to enable a specific imaging technique (tagging), not an AI/CADe device designed to assist human readers in interpretation. There is no AI component or human-in-the-loop performance measurement described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an "algorithm only" device; it's a software option for an imaging system. The "performance" is the ability to generate the tagging patterns, which is inherent to the system's function rather than an interpretation task.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no dedicated clinical performance study with defined ground truth is presented in this document. The "truth" is implicitly aligned with the capabilities of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, K982834 is a submission for a software option that introduces a new imaging technique (cardiac tagging via spatially modulated saturation) to an existing MRI platform. Its clearance is based on demonstrating that this new capability maintains the safety profile of the base MRI system and is substantially equivalent to other devices offering similar tagging functionalities, rather than proving diagnostic accuracy through a dedicated clinical study with defined acceptance criteria for diagnostic performance.

Summary

Regulation Number and Section

§ 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.