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The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.

The MRGP Basic Package is an optional hardware package for the Outlook and Outlook Proview systems. The package includes a foot pedal for starting scans from inside the scan room, kneeling pads for the physician, an MR compatible procedure light, a multipurpose coil with disposable protective coil coverings, and either an in-room LCD display or an in-room Large (36") Screen display. The package uses the standard software and sequences available with the Outlook and Outlook Proview systems.

The provided document is a 510(k) summary for the Picker MR Guided Procedures (MRGP) Basic Package. This document aims to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria through a specific performance study against defined metrics.

Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets them in the way described in the prompt. Instead, it relies on a comparison table to show direct equivalence in technical parameters and indications for use.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) submission demonstrating substantial equivalence, there are no explicitly stated "acceptance criteria" in the sense of performance thresholds the device must meet, nor a study proving it meets these. Instead, the "Substantial Equivalence Chart" presents a comparison of parameters between the new device (MRGP Basic Package) and two predicate devices (Outlook System Enhancement Package and Siemens MR Guided Procedure Package). The underlying "acceptance criterion" is that the parameters of the new device are "Same" or comparable to the predicate devices, implying equivalent safety and effectiveness.

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