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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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