The Picker International EDGE and VISTA systems are 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 EDGE/VISTA system enhancement package includes changes in the computer subsystem, the gradient subsystem, the RF subsystem, the magnet subsystem, the patient handling subsystem, and the magnet enclosure. The main features provided with this enhancement are a 61 cm body coil, three gradient performance levels, water cooled gradients, an increase in the SAR first controlled operating mode limit, and optional increased reconstruction rates.

AI/ML Overview

The provided document is a 510(k) summary for a GE Healthcare product, specifically an enhancement package for their EDGE/VISTA MR systems. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific clinical acceptance criteria through a study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria in the way a clinical trial or performance study would. It focuses on comparing the technical specifications and safety parameters of the new device to existing, legally marketed predicate devices.

Here's why the requested information isn't present and what the document does provide:

No Acceptance Criteria in the context of clinical performance: The document implicitly demonstrates "acceptance" by showing the device's technical specifications and safety profiles are comparable to, or improved upon, predicate devices, indicating it meets general regulatory safety and effectiveness expectations for MR systems. There are no explicit clinical performance metrics (e.g., sensitivity, specificity for a diagnostic task) being tested.
No "Study" as a traditional clinical trial: The document describes modifications and enhancements to an existing MR system. The "proof" is through a comparative table highlighting substantial equivalence in engineering, safety, and operational features. It's not a study in the sense of a clinical investigation with a test set, ground truth established by experts, etc.
No details on sample size, data provenance, expert ground truth, adjudication, MRMC, or standalone performance: These concepts are relevant to clinical performance studies, which are not detailed in this 510(k) summary for a system enhancement.

However, I can extract information related to the technical comparisons made for demonstrating "substantial equivalence," which serves as the "proof" in this context:

1. Table of "Acceptance Criteria" (Implicit Safety/Performance Parameters) and Reported Device Performance

Since there are no explicit "acceptance criteria" for clinical performance, I will present the key technical and safety specifications that are being compared to demonstrate substantial equivalence, considering these as the "criteria" for regulatory acceptance in this context.

Item/Criterion (Implicit)	Predicate Devices (EDGE/VISTA K931544, K954646) Performance	EDGE/VISTA with System Enhancement Package Performance	Comparison Outcome (Proving "Acceptance")
Computer Subsystem	Dedicated Ethernet, single monitor, second Ethernet for external network.	Similar display/database computer, monitor, Ethernet. DICOM v3.0 compliant. Optional increased reconstruction rates.	Substantially Equivalent; added modern communication (DICOM) and optional performance improvements.
Image Storage (Short Term/Archival)	Magnetic Disk/Optical Disk	Same	Substantially Equivalent.
Gradient Coils	Air-cooled (Standard EDGE) or Water-cooled (High Performance Gradients)	Water-cooled self-shielded for all performance levels.	Improved/Equivalent; standardizes to the higher performance, water-cooled model.
Max. Gradient Strength	16 or 27 mT/m	16, 20 or 27 mT/m	Improved/Equivalent; adds an intermediate gradient strength option.
Max. Slew Rate	25 or 72 mT/m/msec	25, 40, 72 mT/m/msec	Improved/Equivalent; adds an intermediate slew rate option.
Gradient Amps	135 A RMS, 220 A peak, 350 V OR 270 A RMS, 440 A peak, 600 V	150 A RMS, 300 A peak, 400 V OR 270 A RMS, 440 A peak, 600 V	Improved/Equivalent; slight increase in the lower-tier amp values.
RF Amplifiers	Single frequency RF amplifiers.	Single frequency RF amplifiers with increased output power (for larger body coil).	Improved/Equivalent; adjusted for new 61cm body coil maintain equivalent B1 field.
Body Coil	58 cm quadrature multi-conductor transmit/receive coil.	61 cm quadrature multi-conductor transmit/receive coil.	Improved; larger body coil for potentially greater patient comfort/versatility.
Patient Handling	Computer controlled patient transport.	Computer controlled patient transport with increased weight capacity. New patient illumination.	Improved; increased capacity and comfort features.
Time Varying Magnetic Field (dB/dt)	Standard EDGE: ≤ 20 T/s. High Performance: Normal ≤ 40 T/s, Controlled 40-60 T/s.	Normal Operating Mode: ≤ 40 T/s. First Controlled Operating Mode: 40 T/s < dB/dt ≤ 60 T/s.	Equivalent to High-Performance Gradient predicate; acceptable within safety limits.
Radiofrequency Absorption (SAR)	Normal: ≤ 1.2 W/kg. Controlled: ≤ 2.4 W/kg.	Normal: ≤ 1.2 W/kg. First Level Controlled Operating Mode: ≤ 3.2 W/kg. Change in RF scale factor acquisition.	Adjusted; Controlled Operating Mode SAR limit increased to 3.2 W/kg, requires demonstration of safety within this limit, presumed to be handled by the change in RF scale factor acquisition method.
Acoustic Noise (Typical)	90.7 dBA (avg), 100.0 dB (peak)	80.6 dBA (avg), 93.3 dB (peak)	Improved; lower average and peak acoustic noise.
Acoustic Noise (Worst Case)	118.7 dBA (avg), 125.6 dB (peak)	115.1 dBA (avg), 123.8 dB (peak)	Improved; lower average and peak acoustic noise.

The remaining requested information is not available in this 510(k) summary document:

2. Sample size used for the test set and the data provenance: Not applicable to this type of regulatory submission (substantial equivalence based on technical comparison).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. 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 is an MR system enhancement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document clearly focuses on technical and safety comparisons to predicate devices rather than clinical performance studies. The "study" here is the engineering and safety analysis performed by the manufacturer to demonstrate that the enhanced system maintains or improves upon the safety and effectiveness of its predecessors.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

K964626

General Information 1.

Classification:	Class IIMagnetic Resonance (MR) Imaging System
Common/Usual Name:	Magnetic Resonance Imaging Option
Proprietary Name:	EDGE/VISTA System Enhancement Package
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadCleveland, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

2. Intended Uses

The EDGE/VISTA System Enhancement Package does not change the existing indications for the EDGE/VISTA systems as defined below.

3. Device Description

PICKER INTERNATIONAL, INC.	(EDGE SE)	11/18/96	I -
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Safety and Effectiveness 4.

The EDGE/VISTA systems with the system enhancement package are similar in technological characteristics and intended use to EDGE/VISTA systems with standard or high performance gradients. The following chart has been created to demonstrate their substantial equivalence.

ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Computer Subsystem	Similar display/databasecomputer, monitor and Ethernetcommunications systems.Ethernet communications linkcomplies with DICOM v3.0 toallow image transfer to other MR,CT, Nuclear, workstation systemsand cameras. Optional packagesavailable for increased imagereconstruction rates.	Display/Database computer andscan reconstruction hardwareconnected together by a dedicatedEthernet communications system.Allows for simultaneous scanningand image reconstruction/manipulation. Single monitor forsystem operation and imagereviewing. Second Ethernetinterface for communication withsystems on the external network.(See K931544)
Image StorageShort Term:Archival:	SameSame	Magnetic DiskOptical Disk(See K931544)
ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Gradient SubsystemGradient Coils:	Water-cooled self-shieldedgradient system for allperformance levels.	Standard EDGE- Air-cooled self-shielded gradient system. (seeK931544)
		EDGE with High PerformanceGradients - Water-cooled selfshielded gradient system (seeK954646)
Max. GradientStrength	16, 20 or 27 mT/m	16 or 27 mT/m
Max. Slew Rate	25, 40, 72 mT/m/msec	25 or 72 mT/m
Gradient Amps:	150 A RMS, 300 A peak, 400 V or270 A RMS, 440 A peak, 600 V	135 A RMS, 220 A peak, 350 Vor270 A RMS, 440 A peak, 600 V
RF SubsystemDTR Spectrometer:	Same	Single Channel with fastsampling ADC and additionaldigital filtering. Three additionalreceive channels are available asan option.
RF Amplifiers:	Single frequency RF amplifierswith increased output power togive equivalent B1 field withlarger body coil.	Single frequency RF amplifiers.(See K931544)
Body Coil	61 cm quadrature multi-conductor transmit/receive coil.	58 cm quadrature multi-conductor transmit/receive coil.(See K931544)
Head Coil	Same	Quadrature multi-conductorreceive only.(See K931544)
ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Receive Only CoilConnection	Same	All receive only coils plug intosingle couch RF connector.
Transmit/Receive Box	Same	Four receive channels in system.(See K931544)
Magnet Subsystem	Same	Active Shield Magnets offered at1.5 T and 1.0 T.(See K931544)
Patient Handling	Computer controlled patienttransport system with increasedweight capacity. New method ofpatient illumination used toincrease patient comfort.	Computer controlled patienttransport system.(See K931544)
Magnet Facade	Cylindrical fiberglass enclosure.Hinge on front facade removed.	Cylindrical fiberglass enclosure.Hinged front facade. (SeeK931544)
Power DistributionSubsystem	Same	Isolation transformer, transientsuppression circuitry, and powerdistribution center all containedin a single cabinet. (SeeK931544)
Operating Software	Same	UNIX - X Windows basedoperating software. GraphicalUser Interface - windows andmulti-tasking capability provided.SCAN, VIEW, FILM andUTILITIES operations allaccessed from single console.Able to switch between on-goingtasks.(See K931544)
ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Operational Features	Same	SCAN capabilities include: Pilotpositioning on three differentreference images. Preloadedanatomical protocol categories.VIEW capabilities include: Multiplanar reconstruction andcurvilinear reformatting.FILM capabilities include: abilityto set film formats and load printqueue directly fromDisplay/Database computer.(See K931544)
Standard ImagingSequences	Same	2DFT: Field Echo, Spin Echo,Multiple Echo, InversionRecovery and FAST.3DFT: FAST
Acquisition andReconstruction Techniques	Same	Main features include: Multi-angle oblique, presaturation,phase conjugate symmetry,TrueRes and TrueSlice.(See K931544)
ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Optional Receive OnlyCoils	All coils for the EDGE/VISTAare compatible with the systemenhancement package.New coils/accessories describedin this submission:Quadrature Lower Extremity CoilCoil Combiner	Large Joint CoilSmall Joint CoilVolume Neck CoilQuad Spine Coil and PositionerGeneral Purpose Flex CoilBilateral TMJ Coil (Linear andPhased Array versions)Bilateral Breast CoilC/T/L Phased ArrayPelvic Phased ArrayHead-Neck Vascular PhasedArrayFlexible Body Coil (Quadratureand Phased Array versions)Quadrature Wrist CoilShoulder Phased Array(See K931544, K932693,K941996, K944469, K952530)
ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Software Options	Software options are the sameexcept for the followingadditions:Variable Fast Spin Echo: 2 and32 echo sequences have beenadded.	AngiographyCardiac ImagingVariable Fast Spin Echo (4, 8, 16,48 and 64 echo sequences withminimum TE's of 16 to 32 msec)Gradient-Recalled and Spin-Echo(GRaSE) TechniqueEcho Planar Imaging(See K931544, K945397,K945828, K954646)
Time Varying MagneticField	All gradient performance levels:Normal Operating Mode:$dB/dt ≤ 40 T/s$First Controlled Operating Mode:$40 T/s < dB/dt ≤ 60 T/s$	Standard EDGE:$dB/dt ≤ 20 T/s$ for all sequences.(see K931544)EDGE with high performancegradients:Normal Operating Mode:$dB/dt ≤ 40 T/s$First Controlled Operating Mode:$40 T/s < dB/dt ≤ 60 T/s$(see K954646)

SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC. (EDGE SE) :

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ITEM	EDGE/VISTA with SystemEnhancement Package	Predicate DevicesEDGE/VISTA (K931544) &High Performance GradientsOption (K954646)
Radiofrequency Absorption	Normal Operating Mode:Limited to a maximum level of1.2 W/kg.	Normal Operating Mode:Limited to a maximum level of1.2 W/kg.
	First Level Controlled OperatingMode: Limited to a maximumvalue of 3.2 W/kg.	First Level Controlled OperatingMode: Limited to a maximumvalue of 2.4 W/kg.(See K931544)
	Change in method for acquiringthe RF scale factor.
Acoustic Noise

Typical	80.6 dBA (average)93.3 dB (peak)	90.7 dBA (average)100.0 dB (peak)
Worst Case	115.1 dBA (average)123.8 dB (peak)	118.7 dBA (average)125.6 dB (peak)(See K931544)

(EDGE SE)

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.