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 (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 Outlook System Enhancement Package includes changes in the computer subsystem, magnet subsystem, gradient subsystem, RF subsystem, patient handling subsystem, magnet enclosure and the power distribution subsystem. The package also includes additional imaging sequences and acquisition/reconstruction techniques. However, the basic features of the operating software are unchanged.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Outlook System Enhancement Package," which is an upgrade to an existing Magnetic Resonance (MR) Imaging System. This submission is for substantial equivalence to a predicate device, rather than a novel device requiring extensive clinical trials to establish its own efficacy and safety from scratch.

Therefore, the typical acceptance criteria and study design elements you've listed (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance) are generally not applicable in the context of a 510(k) for an MRI system enhancement, especially one from 1998.

Instead, the "acceptance criteria" here are demonstrating substantial equivalence to a previously cleared device. The "study" proving this involves a direct comparison of technological characteristics and intended use.

Here's an breakdown based on the provided text, addressing your points where possible and clarifying why others are not present:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for K974844 is demonstrating "substantial equivalence" to the predicate devices: the "Standard Outlook (K945827)" and the "Edge/Vista System Enhancement (K964626)".

The table provided directly within the submission serves as the "study" demonstrating this.

Item	Outlook System Enhancement Package Acceptance Criteria (demonstrated by "Same" or improved features)	Reported Device Performance (Summary of how the new device meets/differs from criteria)
Intended Uses	Must not change existing indications for the standard Outlook system.	"The system enhancement package does not change the existing indications for the standard Outlook system." The device is still indicated for producing images corresponding to proton distribution and NMR parameters to display soft tissue structures for diagnosis by a trained physician.
Technological Characteristics	No new questions of safety or effectiveness regarding computer, magnet, gradient, RF, patient handling, magnet enclosure, power distribution, operating software, imaging sequences, acquisition/reconstruction techniques, coils, static/time-varying magnetic field, RF absorption, and acoustic noise.	The provided "SUBSTANTIAL EQUIVALENCE CHART" explicitly compares the Outlook System Enhancement Package to the predicate devices across 18 items. For many, it states "Same," directly demonstrating equivalence. For others (e.g., increased gradient performance, higher RF amplifier power, increased receive bandwidth, additional imaging sequences), it shows improvement or enhancement while maintaining similarity in overall function and safety. For example:Computer subsystem: Same display/database computer, Ethernet, DICOM 3.0 compliant. Enhancements include additional options, single reconstruction processor (vs 16 parallel), and additional hard disk.Magnet subsystem: Iron C-arm magnet, improved ramp-up time (6 min vs 10 min), increased magnetic field stability.Gradient subsystem: Increased gradient performance with active shielded design (vs 12 mT/m and 20 T/m/s shielded).RF subsystem: RF amplifier max average power 500 W (vs 250 W), receive bandwidth ± 100 kHz (vs ± 50 kHz).Operating software: Same.Imaging Sequences: Same with enhancements to Inversion Recovery and Fast Spin Echo sequences.Acquisition and Reconstruction Techniques: Same with addition of Read Conjugate Symmetry, TrueRes, Keyhole.Receive Only Coils: Similar range, with "Brain" coil added and "Body" coil becoming "Body/Spine."Static Magnetic Field: Same (0.23 T).Time Varying Magnetic Field: Same (Normal mode $\le 40$ T/s, First level controlled mode $\le 60$ T/s).Radiofrequency Absorption: Same (Normal mode $\le 1.2$ W/kg, First level controlled mode $\le 3.2$ W/kg).Acoustic Noise: Same (A-weighted average < 85 dBA).
Performance (Imaging Quality)	Maintain diagnostic utility comparable to predicate devices.	While not explicitly quantified with metrics like SNR or resolution, the claim of "enhancements" to imaging sequences and acquisition/reconstruction techniques (e.g., TrueRes, Keyhole) implies improved or at least maintained image quality. The primary evidence is the substantial equivalence in other technical specifications, suggesting the diagnostic output remains equivalent or better.

Study Details (As applicable to a 510(k) for an MR System Enhancement)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for this type of submission. This 510(k) is based on engineering comparison and performance specifications, not a clinical study involving patient data. There is no "test set" of clinical images or patient data to evaluate. The "test" is the comparison of technical specifications against predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" established by experts for a test set in this type of submission. The ground truth for substantial equivalence is the technical specifications and performance of the predicate device itself, which was already cleared by the FDA.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or expert adjudication process was described or required for this type of 510(k).
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 MRI system enhancement, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is hardware and software enhancement for an MRI system, not a standalone diagnostic algorithm. The device's "performance" is its ability to acquire images, not interpret them. Interpretation is explicitly stated to be "by a trained physician."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the conventional sense. The "ground truth" for this submission is the established safety and effectiveness profile of the predicate MR systems, as determined by their prior FDA clearances (K945827 and K964626). The applicant demonstrates that their new device either matches or improves upon these predicate specifications without raising new questions of safety or effectiveness.
The sample size for the training set:
- Not applicable. There is no AI model or algorithm being "trained" with data in this submission. This is a hardware and software upgrade.
How the ground truth for the training set was established:
- Not applicable. As no training set exists, no ground truth needed to be established for it.

Summary

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K97 4844

MAR 1 0 1998

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

General Information 1.

Classification:

Class II Magnetic Resonance (MR) Imaging System

Common/Usual Name:

Magnetic Resonance (MR) Imaging Option

Proprietary Name:

Outlook System Enhancement Package

Establishment Registration:

Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-00511 Helsinki, Finland +358-9-394 127 Phone: +358-9-146 2811 Fax. FDA Facility Registration #9680194

United States Representative: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240

Performance Standards:

No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.

2. Intended Uses

The system enhancement package does not change the existing indications for the standard Outlook system as defined below.

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Device Description 3.

Safety and Effectiveness 4.

Outlook systems with the System Enhancement Package are similar in technological characteristics and intended use to the standard Outlook system and the EDGE/VISTA System Enhancement Package. The following chart has been created to demonstrate their substantial equivalence.

Item	Outlook System EnhancementPackage	Predicate DevicesStandard Outlook (K945827)Edge/Vista SystemEnhancement (K964626)
Computer subsystem	Same display/database computersystem with some additionaloptions.Ethernet communication systemScan/reconstruction hardware:• single processor forreconstruction• additional hard disk for bufferingimage raw dataDICOM 3.0 compliant	Display/database computer system:• workstation• single monitor• movable keyboard and mouse• magnetic disk storage• optical disk storage• CD-ROMEthernet communication systemScan/reconstruction hardware:• 16 parallel processors forreconstruction(See K945827)DICOM 3.0 compliant. (SeeK964626)
Magnet subsystem	• Iron C-arm magnet• Ramp up time: 6 minutes• Increased stability of magneticfield	• Iron C-arm magnet• Ramp up time: 10 minutes(See K945827)
Item	Outlook System EnhancementPackage	Predicate DevicesStandard Outlook (K945827)Edge/Vista SystemEnhancement (K964626)
Gradient subsystem	Increased gradient performancewith an active shielded design.	Gradient performance level of 12mT/m and 20 T/m/s with ashielded design. (See K945827)
RF subsystem• RF amplifier maxaverage power	• 500 W	• 250 W
• Receive bandwidth	• ± 100 kHz	• ± 50 kHz(See K945827)
Patient Handlingsubsystem	• Modified couch movable in twodirections	• Couch movable in two directions
	• Laser positioning	• Laser positioning(See K945827)
Magnet Enclosure	Fiberglass enclosure re-designed toaccommodate patient handlingsubsystem.	Fiberglass enclosure.(See K945827)
Power Distributionsubsystem	Same with the addition of linevoltage monitoring circuitry.	Isolation transformer, transientsuppression circuitry, powerdistribution center all contained ina single cabinet. (See K945827)
Operating software	Same.	Windows NT based GraphicalUser Interface and scan /reconstruction software withmulti-tasking capability.(See K945827)
Imaging Sequences	Same with enhancements toInversion Recovery and Fast SpinEcho sequences.	Standard: Field Echo, Spin Echo,Inversion Recovery, Dual Echo,and CBASS.
		Optional: Fast Spin Echo andAngiography. (See K945827)
Item	Outlook System EnhancementPackage	Predicate DevicesStandard Outlook (K945827)Edge/Vista SystemEnhancement (K964626)
Acquisition andReconstructionTechniques	Same with addition of:• Read Conjugate Symmetry• TrueRes• Keyhole	Main features include:• Presaturation• MAST• Optimized Data Acquisition• Phase Conjugate Symmetry• No Phase Wrap-Around• No Slice Wrap-Around• Dynamic Imaging• Cardiac gating• Optimized Bandwidth• Turbo Multislice(See K945827)
Receive Only Coils	• Head• Brain• Vascular Head and Neck• Neck• Body/Spine• Flexible Spine• Multipurpose• Extremity• Small Joints	• Head• Vascular Head and Neck• Neck• Body• Spine• Flexible Spine• Multipurpose• Extremity(See K945827)
Static MagneticField	Same.	0.23 T (See K945827)
Time VaryingMagnetic Field	Same.	Normal operating mode:$dB/dt \le 40$ T/sFirst level controlled operatingmode:$dB/dt \le 60$ T/s(See K964626)
RadiofrequencyAbsorption	Same.	Normal operating mode: Limitedto a maximum level of 1.2 W/kg.First level controlled operatingmode: Limited to a maximumlevel of 3.2 W/kg. (See K964626)
Acoustic Noise	Same.	A-weighted average value < 85dBA. (See K945827)

SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(OUTLOOK SE) 12/23/97

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I - 3

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PICKER INTERNATIONAL, INC.

(OUTLOOK SE) 12/23/97 I - 4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Duane C. Praschan Manager, MR Regulatory Affairs and Clinical Testing Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

Re: K974844

Outlook System Enhancement Package Dated: December 22, 1997 Received: December 24, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Praschan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K47 4844

Device Name: Outlook System Enhancement Package

Indications for Use:

The system enhancement package does not change the existing indications for the standard Outlook system as defined below.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segarra

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974844

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use (Optional Format 1-2-96)

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.