The Picker Outlook system is intended 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 Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.

Device Description

The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, specifically an MRI coil. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performing an in-depth study to prove the device meets these criteria in the way a novel diagnostic AI algorithm might.

Therefore, many of the requested elements for an AI or diagnostic device study are not applicable in this context. The "acceptance criteria" here are essentially the demonstration of equivalent performance and safety characteristics to the predicate devices.

Here's an attempt to address your request based on the provided document, highlighting where the information is not present or not directly applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (Outlook Large Phased Array Neck Coil)
Safety	Equivalent to predicate devices (USAI Quadrature Volume Neck Coil, Picker Phased Array Neck Coil) in:- Enclosure Material- Coil Design- Decoupling- Prevention of Resonant Loops- Prevention of RF burns- Radio Frequency Absorption	Same as predicate devices
Effectiveness (Indications)	Equivalent indications for use as predicate devices.	"The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region." (Same as predicate)
Intended Use	Equivalent intended use as predicate devices (for NMR imaging for diagnosis by a trained physician).	Same as predicate devices
Compatibility	Compatible with Picker 0.23T Outlook system.	Compatible with Picker 0.23T Outlook system
Tuning Scheme	Automatically tuned for each patient, equivalent to predicate.	Automatically tuned for each patient
Anatomic Regions	Neck, from cerebellum to upper thoracic spine, equivalent to predicate.	Neck
Nuclei Excited	Hydrogen, equivalent to predicate.	Hydrogen

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

Not applicable. This submission relies on demonstrating substantial equivalence to existing devices, primarily through comparison of design, materials, and functional specifications, rather than a clinical trial with a "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth in the context of diagnostic interpretation is established for this submission. The "ground truth" for regulatory approval is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or human interpretation adjudication was part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not a study comparing human reader performance with and without AI assistance. It's a device comparison for substantial equivalence.

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

Not applicable. This is a physical medical device (an MRI coil), not a standalone algorithm.

7. The Type of Ground Truth Used

Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is the regulatory acceptance and established safety/effectiveness of the predicate devices (USAI Quadrature Volume Neck Coil and Picker Phased Array Neck Coil). The manufacturer is asserting that the new device is functionally identical or very similar in all critical aspects affecting safety and efficacy.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or a clinical trial for this type of device.

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

Not applicable. See point 8.

Summary

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JUL 3 / 1998

K981959

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

General Information 1.

Classification:	Class IIMagnetic Resonance Imaging (MRI) Accessory
Common/Usual Name:	Magnetic Resonance Imaging (MRI) Coil
Proprietary Name:	Outlook Large Phased Array Neck Coil
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards.	Not Applicable

Intended Uses 2.

The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.

Anatomic Regions:	Neck
Nuclei Excited:	Hydrogen

3. Device Description

PICKER INTERNATIONAL, INC.	(LNECK)	5/22/98	I -
----------------------------	---------	---------	-----

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Safety and Effectiveness 4.

୍କ ଦି

The Picker Large Phased Array Neck Coil is substantially equivalent in safety and effectiveness to the USA Instruments (USAI) Quadrature Volume Neck Coil and the Picker Phased Array Neck Coil. The following chart has been compiled to demonstrate the substantial equivalence of these devices.

Parameter	Large Phased ArrayNeck Coil	Predicate DevicePicker - Outlook Neck Coil (K964678)USAI - Profile 7000 Neck Coil (K964531)
Compatibility	Picker 0.23T Outlook system	Hitachi 1.5T MRH-1500 system(See K964531)
Enclosure Material	Same.	Royalite R59 ABS/PVC alloy(See K964531)
Coil Design	Two-channel receive-onlyphased array coil.	Two-channel receive-only quadrature coil(See K964531).
Decoupling	Same.	Switching Diode decoupling.(See K964531)
Formation of ResonantLoops	Same.	Length of cable and stiffness does notpermit looping (See K964531 or K964678)
Potential for RF burns	Same.	Limited by the following:1) Does not transmit RF power2) Coil elements and circuitry encased innon-conductive material.3) Decoupling isolates the coil elementsfrom transmitted RF.(See K964531 or K964678)
Radio FrequencyAbsorption	Same.	Coil is receive-only and does not transmitRF power. Power deposition duringimaging is limited by the system SARalgorithm. (See K964531 or K964678)
Tuning Scheme	Same.	Automatically tuned for each patient.(See K964678)

(LNECK)

5/22/98

I - 2

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Parameter	Large Phased ArrayNeck Coil	Predicate DevicePicker - Outlook Neck Coil (K964678)USAI - Profile 7000 Neck Coil (K964531)
Indications for Use	Same.	The Phased Array Neck Coil is indicated foruse in providing coverage of the neck, fromthe cerebellum to the upper thoracic spineregion.Anatomic Regions: NeckNuclei Excited: Hydrogen(See K964678)
Intended Use	Same.	The Picker Outlook system is intended foruse as a NMR device that produces imagesthat: (1) correspond to the distribution ofprotons exhibiting NMR, (2) depend uponthe NMR parameters (proton density, flowvelocity, spin-lattice relaxation time (T1),and spin-spin relaxation time (T2)) and 3)display the soft tissue structure of the headand whole body. When interpreted by atrained physician, these images yieldinformation that can be useful in thedetermination of a diagnosis.(See K964678)

PICKER INTERNATIONAL, INC.

ﻤﺴﺘﺸﻔﻪ

(LNECK)

11:40 PM IST

5/22/98

I - 3

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 1000

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143

Re:

K981959 Outlook Large Phased Array Neck Coil Dated: June 2, 1998 Received: June 4, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

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 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 II (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 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 vito 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/dsmaldsmamain.html".

Sincerely yours,

William Yn

Lillian Yin, Ph.D. 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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510(k) Number (if known): K981959

Large Phased Array Neck Coil Device Name:

Indications for Use:

The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.

Anatomic Regions: Neck Nuclei Excited: Hydrogen

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

William

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981959

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.