The EPI-II System Option with High Performance Gradients is designed to provide higher gradient output power in order to allow the user to acquire images at a faster rate or acquire images with a higher spatial resolution than would normally be possible with a standard EDGE system with the EPI-I software option. The indications for use are the same as for standard MR imaging.

The Picker International EDGE 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 (T1), 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.

Device Description

The EPI-II System Option with High Performance Gradients consists of water-cooled non-resonant self-shielded gradient coils, high performance gradient amplifiers, single-shot echo-planar sequences, and modified standard sequences.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the EPI-II System Option as having higher performance capabilities compared to a predicate device (standard EDGE system with EPI-I software) rather than presenting explicit "acceptance criteria" against which a direct performance measurement is assessed. The safety and effectiveness sections outline how the EPI-II system improves upon the previous version.

Feature/Parameter	Acceptance Criteria (Implied/Predicate Performance)	Reported Device Performance (EPI-II)
Total dB/dt (Time Varying Magnetic Field)	Not to exceed 20 T/s (IEC 601-2-33 method)	Software warns >40 T/s, prohibits >60 T/s (FDA guidance)
SAR Algorithm	Limited to specific W/kg for Normal, First, Second Level	Same as predicate (limits power deposition)
Acoustic Noise (Worst Case, Average)	118.7 dBA (Standard EDGE system)	109.1 dBA
Acoustic Noise (Worst Case, Peak)	127.8 dB (Standard EDGE system)	119.5 dB
Gradient Amplifiers	135 A RMS, 220 A peak, 350 V max. (Predicate K931544)	270 A RMS, 440 A peak, 600 V max.
Max Gradient Strength	16 mT/m (Predicate)	27 mT/m
Max Slew Rate	25 mT/m/msec (Predicate)	72 mT/m/msec
Fast Scanning Sequences	Multi-Shot EPI (Predicate K945828)	Single-shot EPI
EPI Data Correction	Automated process (Predicate K945828)	Interactive prescan process
Standard Imaging Sequences	Lower output power limits resolution, inter-echo spacing, etc.	Increased image resolution or redesigned for shorter inter-echo spacing, shorter echo times, and/or increased motion artifact suppression

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

The provided text does not contain any information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This device is an MRI system option, and the "effectiveness" section focuses on hardware and software upgrades enabling faster imaging and higher spatial resolution, not a diagnostic algorithm evaluated on patient data.

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

As there is no mention of a test set or ground truth in the context of patient data/diagnoses, there is no information about experts or their qualifications for establishing such ground truth. The effectiveness claims are based on technical specifications and functional improvements of the MRI system itself.

4. Adjudication Method for the Test Set

Since no test set evaluating a diagnostic outcome is described, there is no information about an adjudication method.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on improvements in scanner capabilities (speed, resolution) rather than the diagnostic interpretive performance of human readers with or without AI assistance.

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

This document describes an MRI system option, not a standalone algorithm for diagnostic interpretation. Therefore, no standalone algorithm performance study is described. The "EPI Data Correction" for the EPI-II is described as an "Interactive prescan process," implying human involvement, while the predicate was automated.

7. Type of Ground Truth Used

The "ground truth" implicitly used for the effectiveness claims of this MRI system option is based on engineering specifications and measurements of physical parameters (e.g., gradient strength, slew rate, acoustic noise, imaging speed, spatial resolution) directly related to the hardware and software capabilities. It is not related to clinical outcomes, pathology, or expert consensus on diagnostic images in the way a diagnostic AI would be evaluated.

8. Sample Size for the Training Set

As this document describes an MRI system's hardware and software capabilities rather than a machine learning algorithm requiring a "training set" of data, the concept of a training set sample size is not applicable and is not mentioned.

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

Similar to point 8, since there is no mention of a training set, how its "ground truth" was established is not applicable and is not discussed.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

General Information i.

	Classification:	Class IIMagnetic Resonance (MR) Imaging System
	Common/Usual Name:	MRI System Option
	Proprietary Name:	EPI-II System Option with High PerformanceGradients
	Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadCleveland, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
	Performance Standards:	Not applicable
2.	Intended Uses:	The EPI-II System Option with HighPerformance Gradients is designed to providehigher gradient output power in order to allowthe user to acquire images at a faster rate oracquire images with a higher spatial resolutionthan would normally be possible with a standardEDGE system with the EPI-I software option.The indications for use are the same as forstandard MR imaging.
3.	Device Description:	The EPI-II System Option with HighPerformance Gradients consists of water-coolednon-resonant self-shielded gradient coils, highperformance gradient amplifiers, single-shot echo-planar sequences, and modified standardsequences.

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Safety and Effectiveness 4.

a. Safety

As shown in the chart below, the Picker EPI-II System Option with High As shown in the chart below, the ricker the riskel to the standard EDGE Performance Gradients for an EDGE System is identical to the day and levels and software algorithm.

EDGE with EDGE with Parameter EPI-I Software Option EPI-II System Option Same Static Magnetic Field Same Corresponding to proton Concepce of 63.75 MHz (EDGE). Not to exceed 20 T/s (as Total dB/dt software Time Varying Magnetic measured according to algorithm warns when Field method in IEC 601-2-33). operational level is above 40 T/s and prohibits operation above 60 T/s (as measured by method in FDA's draft guidance document).

SAFETY CHART

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Parameter	EDGE withEPI-II System Option	EDGE withEPI-I Software Option
Radio FrequencyAbsorption	Same	Same
Power deposition duringimaging is limited by theSAR algorithm to amaximum value of:1.2 W/kg NORMALOPERATING MODE2.4 W/kg FIRSTLEVEL CONTROLLEDOPERATING MODE> 2.4 W/kg SECONDLEVEL CONTROLLEDOPERATING MODE(Requires human studiesprotocol approvalaccording to localrequirements.)
Acoustic Noise	Acoustic noise levels ofEPI-II System Optionunder worst caseconditions are: 109.1 dBA(average) and 119.5 dB(peak).	Acoustic noise levels ofstandard EDGE systemunder worst caseconditions are: 118.7 dBA(average) and 127.8 dB(peak).

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Parameter	EDGE withEPI-II System Option	EDGE withEPI-I Software Option
Intended Use:	Same	Same
The Picker InternationalEDGE system is indicatedfor use as a NMR devicethat produces images that:(1) correspond to thedistribution of protonsexhibiting NMR, (2)depend upon the NMRparameters (protondensity, flow velocity, spin-lattice relaxation time(T1), and spin-spinrelaxation time (T2)) and(3) display the soft tissuestructure of the head andwhole body. Wheninterpreted by a trainedphysician, these imagesyield information that canbe useful in thedetermination of adiagnosis.
Parameter	EPI-II System Option	Predicate
Gradient Coil Design	Water-cooled, highperformance, self-shieldednon-resonant gradientsystem.	Basic EDGE system usesa standard performance,air cooled, self-shieldedgradient system. (see510(k) K931544).
Gradient Power	Gradient Amplifiers:270 A RMS, 440 A peak,600 V max.	Gradient Amplifiers:135 A RMS, 220 A peak,350 V max.(see 510(k) K931544)
Gradient Performance	Maximum GradientStrength = 27 mT/m	Maximum GradientStrength = 16 mT/m
	Maximum Slew Rate =72 mT/m/msec	Maximum Slew Rate =25 mT/m/msec
Fast Scanning Sequences	Single-shot EPI fastscanning sequences. Entireimage collected following asingle RF excitation usingmultiple gradient recalledechoes.	Multi-Shot EPI fastscanning sequences. Anumber of RF excitationsare required to collect anentire image. Multiplegradient recalled echoesused to collect data. (see510(k) K945828)
EPI Data Correction	Interactive prescanprocess.	Automated process whichdoes not require operatorinvolvement. (see 510(k)K945828)
IR Prep Pulse	Improves T1 imagecontrast.	Same. (see 510(k)K945828).
Standard ImagingSequences	Increased image resolutionor redesigned for: shorterinter-echo spacing; shorterecho times; and/orincrease motion artifactsuppression.	Standard image resolution,inter-echo spacing, echotimes, and motion artifactsuppression, limited by thelower output power of thegradient system.

b. Effectiveness

Compared to the standard EDGE system using the EPI-I software option (see Compared to the standard EDOD of the EPI-II System Option has a gradient system SID(K)S R931344 and 18745020), the dient operational levels and provide faster which is and to produce inguil System Option also includes EPI single shot sequences.

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EFFECTIVENESS CHART

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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.