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.

The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

Device Description

The main features in the Optical Tracking Unit include: 1) infrared digitizer hardware; 2) specialized tools and tracking devices for procedures; 3) software that guides the imaging plane based on information from the digitizer; 4) software utilities that allow for slice reformatting of 3D image sets and 5) MRGP graphical overlays for planning and intraoperative use.

This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for the "MRGP Optical Tracking Unit," an accessory for Magnetic Resonance Imaging (MRI) systems. The document establishes substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a diagnostic AI device.

Therefore, many of the requested elements (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable or not provided in this specific type of regulatory submission. This document focuses on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics like sensitivity, specificity, or accuracy that would typically be found for a diagnostic AI device. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various technical parameters and indications for use. The "reported device performance" is implicitly that it functions equivalently to the predicate devices.

Parameter	Acceptance Criteria (Predicate Equivalent)	Reported Device Performance (MRGP Optical Tracking Unit)
System Compatibility	0.23T Outlook, 0.23T Outlook Proview	Same (compatible with 0.23T Outlook, 0.23T Outlook Proview)
Software	Standard Outlook Software	Special MRGP Software for the Outlook
Imaging Plane Selection	Manual	Optically Guided (This is a distinguishing feature, but shown to achieve the same outcome as manual guidance in the predicate, i.e., guiding diagnostic/therapeutic interventional procedures)
Sequence type	2D/3D Gradient echo, FSE, Single-shot FSE	Same (2D/3D Gradient echo, FSE, Single-shot FSE)
Sequence capabilities	Dynamic imaging with auto start and keyhole imaging capabilities. Typical reconstruction of 200 ms per image.	Same (Dynamic imaging with auto start and keyhole imaging capabilities. Typical reconstruction of 200 ms per image.)
Sequence resolution	FOV- 4 to 40 cm; Slice thickness- 2D: 1-100mm (0.1mm steps), 3D: 0.4-100mm (0.1mm steps); Matrix- up to 512	Same (FOV- 4 to 40 cm; Slice thickness- 2D: 1-100mm (0.1mm steps), 3D: 0.4-100mm (0.1mm steps); Matrix- up to 512)
Type of Digitizer	Infrared signals emitted from the Position Sensor Assembly (PSA) are reflected off reflective markers mounted on the tool. The reflected signal is detected by the PSA with two optical detectors.	Same (Infrared signals emitted from the Position Sensor Assembly (PSA) are reflected off reflective markers mounted on the tool. The reflected signal is detected by the PSA with two optical detectors.)
Max. Digitizer Rate	30 Hz for one or two tools; for three tools, the rate is 30 Hz for one of the tools and 15 Hz for the other two.	Same (30 Hz for one or two tools; for three tools, the rate is 30 Hz for one of the tools and 15 Hz for the other two.)
Active Digitizer Volume	Silo shape, with 1 meter diameter and 1 meter length.	Same (Silo shape, with 1 meter diameter and 1 meter length.)
Type of Sterilization	Tool bodies are steam sterilized and the reflective spheres are sterilized with ETO.	Same (Tool bodies are steam sterilized and the reflective spheres are sterilized with ETO.)
Material Composition of tool bodies	Aluminum, titanium or stainless steel	Polyethermide and Polyphenylsulfone (This is a differentiating parameter, but is likely considered equivalent in terms of safety and function for its intended use, as implied by the substantial equivalence determination)
Indications for Use	Support and guide diagnostic interventional procedures, such as needle biopsies and drainages.	Designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages. (Expands on "therapeutic" in addition to "diagnostic" compared to one predicate, but still considered substantially equivalent to the overall combined functionality of the predicates).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document is a 510(k) submission based on substantial equivalence to existing predicate devices, not a performance study that would typically involve a "test set" of patient data for evaluating an algorithm's performance.

3. 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. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

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. No MRMC study is described. The device is a physical/software accessory for interventional MRI, not an AI diagnostic aid that assists human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an optical tracking unit designed to "support and guide" procedures, inherently requiring human interaction and interpretation. It is not an autonomous algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth is mentioned in the context of device performance evaluation as it would be for a diagnostic algorithm. Substantial equivalence is based on comparing device specifications and intended use.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device being evaluated in that manner.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary

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AUG 23 1999

99 1943

SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

General Information 1.

Classification:	Class IIMagnetic Resonance Imaging (MRI) System
Common/Usual Name:	Magnetic Resonance Imaging (MRI) Option
Proprietary Name:	MRGP Optical Tracking Unit
Establishment Registration:	Manufacturer:Picker Nordstar, Inc.Ayritie 4, VantaaFIN-01510 Vantaa FinlandFDA Facility Registration: #9680194United States Representative:Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143Contact: Elaine K. Keeler, Ph.D.Phone: (440) 473-3000FDA 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 MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

PICKER INTERNATIONAL, INC.	(MRGP-OP)	05/27/99	I.-
----------------------------	-----------	----------	-----

{1}------------------------------------------------

3. Device Description

This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).

Safety and Effectiveness 4.

The following substantial equivalence chart has been compiled to demonstrate the equivalence of the MRGP Optical Tracking Unit described in this submission with the Picker MRGP Basic Package (K983342) and the Picker ViewPoint Passive Tool Option (K990868).

Parameter	MRGP Optical TrackingUnit	Predicate Devices
System Compatibility	Same.	0.23T Outlook,0.23T Outlook Proview(See K983342)
Software	Special MRGP Software forthe Outlook.	Standard Outlook Software.(See K983342)
Imaging Plane Selection	Optically Guided.	Manual. (See K983342)
Sequence type	Same.	2D/3D Gradient echo, FSE, Single-shot FSE. (See K983342)
Sequence capabilities	Same.	Dynamic imaging with auto start andkeyhole imaging capabilities.Typical reconstruction of 200 msper image. (See K983342)
Sequence resolution	Same.	FOV- 4 to 40 cmSlice thickness-2D: 1-100mm (0.1mm steps)3D: 0.4-100mm (0.1mm steps)Matrix- up to 512(See K983342)

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(MRGP-OP)

{2}------------------------------------------------

Parameter	MRGP Optical TrackingUnit	Predicate Devices
Type of Digitizer	Same.	Infrared signals emitted from thePosition Sensor Assembly (PSA) arereflected off reflective markersmounted on the tool. The reflectedsignal is detected by the PSA withtwo optical detectors.(See K990868)
Max. Digitizer Rate	Same.	30 Hz for one or two tools; for threetools, the rate is 30 Hz for one ofthe tools and 15 Hz for the othertwo. (See K990868)
Active Digitizer Volume	Same.	Silo shape, with 1 meter diameterand 1 meter length. (See K990868)
Type of Sterilization	Same.	Tool bodies are steam sterilized andthe reflective spheres are sterilizedwith ETO. (See K990868)
Material Composition oftool bodies	Polyethermide andPolyphenylsulfone	Aluminum, titanium or stainless steel(See K990868)
Indications for Use	The MRGP Optical TrackingUnit is designed to support andguide diagnostic andtherapeutic interventionalprocedures, such as needlebiopsies and drainages.	The MRGP Basic Package isdesigned to support and guidediagnostic interventional procedures,such as needle biopsies anddrainages. (See K983342)

PICKER INTERNATIONAL, INC.

(MRGP-OP)

05/27/99

I - 3

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The background is white.

Image /page/3/Picture/1 description: The image contains a logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a circle. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 1999

Elaine Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

K991943 Re:

MRGP Optical Tracking Unit (Interventional MRI Accessory) Dated: June 7, 1999 Received: June 9, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Keeler:

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 legally marketed predicate 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 prohibitions 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 Requlations, 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 (QS) 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 predicate device results in a classification 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MRGP Optical Tracking Unit Device Name:

Indications for Use:

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 Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991943

Prescription Use (Per 21 CFR 801.109)	OR	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.