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The RestGrid Option on the Gyroscan NT and Gyroscan CV is used to evaluate regional heart wall motion and blood flow in a non-invasive study..

The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems.

This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study.

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.

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.

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.

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.

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no test set described.
4. 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.
5. 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.
6. 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.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. 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.

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The Philips Gyroscan NT Release 6 series have the same intended use as its predecessor and predicate device Gyroscan NT Release 5. The Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra. based upon 'H and ''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.

The predicate device Gyroscan NT Release 5 series with the additions mentioned hereafter is called Gyroscan NT Release 6 series.

• The Synergy coils are based on the same principles of the existing Philips synergy coil but their physical design is as such for better matching with the ROI to be imaged.
• Synergy Body coil: This coil consists of four coil elements to image the ROI in the abdomen and the pelvic or thoracic area.
• Synergy Cardiac: This coil consists of 5 coil elements to image the heart and its coronary vessels
• Contrast Enhanced Angiography (CE-MRA) Package - BolusTrak.
• Contrast Enhanced Peripheral Angiography Package - MobiTrak.
• Respiratory Navigators (MotionTrak) is an extension to the MR Cardiography package which offers the possibility to monitor the diaphragm position of the patient during scanning. Additional MR signals are acquired interleaved with the normal MR acquisition and evaluated in real-time. These navigator signals are used to determine the position of the imaging volume to enable gating and slice correction.
• MR Neuro Imaging Package provide dedicated acquisition, reconstruction techniques resulting in functional rather than anatomical information. It contains:
  o MR Perfusion Package. Enhanced 3D FFE and 3D FFE-EPI techniques , so-called PRESTO, which allows fast acquistion with large anatomical coverage. It provides high temporal information for evaluation of dynamic contrast agent studies.
  o MR Bold Imaging Package. Extensions to the PRESTO technique with respect to motion correction, acquistion and recontruction, which offers the possibility of visualization of small susceptibility changes.
  Introduction of Gyroscan CMR:
  The dedicated cardiac version , based on the Gyroscan NT platform, will be marketed as Gyroscan CMR. The latter has the same performance as the NT version except for its appearance, i.e. the name and the color of the system covers.

The provided text is a 510(k) summary for the Philips Gyroscan NT Release 6 series, an MRI device. It describes the device's intended use and technological characteristics, comparing it to its predicate device (Gyroscan NT Release 5 series) to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria, device performance metrics, specific studies (like comparative effectiveness or standalone performance), sample sizes, data provenance, ground truth establishment, or expert qualifications and adjudication methods.

The summary focuses on:

• Device Name: Philips Gyroscan NT Release 6 series
• Classification: Magnetic Resonance Diagnostic Device, Class II
• Intended Use: Diagnostic imaging of the head, body, or extremities, producing cross-sectional images, spectroscopic images, and/or spectra based on 1H and 31P metabolites. These images/spectra, when interpreted by a trained physician, assist in diagnosis. This is stated to be the same as the predicate device.
• Description of Changes from Predicate:
  • New Synergy coils (Body coil, Cardiac coil)
  • Contrast Enhanced Angiography (CE-MRA) Package - BolusTrak
  • Contrast Enhanced Peripheral Angiography Package - MobiTrak
  • Respiratory Navigators (MotionTrak)
  • MR Neuro Imaging Package (MR Perfusion Package with PRESTO and MR Bold Imaging Package)
  • Introduction of Gyroscan CMR (a dedicated cardiac version with the same performance as the NT version).
• Safety and Effectiveness: States that the extensions to Release 5 do not induce any other risks than those already known with MRI techniques.
• Substantial Equivalence: Declares the device substantially equivalent to the predicate device (GYROSCAN NT Release 5 series).

Since this is a 510(k) summary for an MRI system and not an AI or diagnostic algorithm, the typical performance metrics (sensitivity, specificity, AUC) and study design elements (sample size, ground truth, experts, adjudication) asked for in the prompt are not applicable or reported in this type of submission. The 'performance' of such a device is generally established through engineering specifications, image quality assessments, and safety standards rather than clinical diagnostic accuracy studies in the way an AI algorithm would be.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because the provided document does not contain this information. The document solely focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway that doesn't typically require de novo clinical performance studies for diagnostic accuracy in the way an AI medical device might.

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Diffusion Weighted Imaging is intended for use in generating unique contrast/information about the diffuse mobility of water or other proton containing molecules. Changes in mobility of the apparent diffusion coefficients in tissue can be seen much earlier phase than originally possible with conventional proton density, T1 or T2 weighted imaging. This change indicates neurological anomalies, of which diagnosis of acute stroke is one of the important applications.

Diffusion Weighted Imaging generates contrast/information about the apparent diffusion coefficients that reflect the anisotropic nature of tissue composition (e.g. fiber tracts in brain white matter) that otherwise cannot be visualized by conventional proton density, T1 or T2 weighted imaging.

Sensitivity to diffusion has been induced by applying two identical large magnetic field gradient pulses, socalled diffusion gradients, to the basic (SE or SE-EPI) pulse sequences.

One diffusion gradient is applied before the 180 degree refocussing RF pulse and the second after the 180 degree RF pulse. During imaging static spins will be dephased as a result of the first applied diffusion gradient followed by complete rephasing by the second gradient pulse. If the molecules are moving inbetween the two diffusion gradients, non-complete rephasing will occur, resulting in the diffusion weighting. Diffusion Weighted Imaging (DWI) on the Philips Gyroscan NT systems is offered in the following two optional packages:

• Diffusion package: allowing basic DWI sequences, based on Spin Echo (SE) sequences in combination . with motion reduction techniques.
• Extended Diffusion Package: allowing faster acquisition as DWI is based on Spin Echo Planar ● Imaging (SE-EPI) sequences with motion rechniques. Both Single Shot Diffusion EPI as well as multi-shot Diffusion EPI versions are possible.

The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document describes the device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices, but it does not present performance data or clinical study results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details about a study.

Here's a breakdown of why the requested information is absent from the provided text:

• Acceptance Criteria and Reported Device Performance: This type of information would typically be presented as quantitative metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, spatial resolution) with target values and the device's demonstrated achievement of those values. The document only discusses general improvements in detecting neurological anomalies earlier.
• Sample Size and Data Provenance (Test Set): No test set with specific numbers of cases or their origin (country, retrospective/prospective) is mentioned.
• Number of Experts and Qualifications (Ground Truth): There is no mention of experts establishing ground truth or their qualifications.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe any study comparing human readers with and without AI assistance.
• Standalone Performance Study: While the device itself is a standalone imaging package, the document does not present a standalone performance study with specific metrics. It talks about the capabilities of the diffusion-weighted imaging but not its performance in a structured study.
• Type of Ground Truth Used: The document doesn't specify how the "truth" of neurological anomalies or diffusion coefficient changes would be established for any performance evaluation.
• Sample Size for Training Set: No training set is mentioned as this device is a new imaging sequence for an existing MRI system, not an AI/CAD device that requires a training set.
• How Ground Truth for Training Set was Established: Not applicable as no training set is mentioned.

The document primarily focuses on demonstrating substantial equivalence to predicate devices by highlighting that the new sequences are extensions of existing, approved MRI techniques and do not introduce new safety risks. This is a common approach for 510(k) submissions where the technology is an evolution rather than a completely novel device with entirely new performance metrics to establish.

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