The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.

Device Description

The Insight Head Coil is a quadrature transmitting and receiving device for use in magnetic resonance imaging of the head regions. This device incorporates advanced radio frequency technology housed in a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patients eyes, nose or mouth. The materials of construction and components are all identical to the predicate devices.

The tubular shaped coil is 13" OD x 9.9" ID x 10" L with a section removed from the bottom that is 60° of the coil circumference and 2" deep. The coil is attached to 2 rails that allow it to slide back and away from the patient, and then to be positioned with the patients head inside the tubular device. The back and sides of the coil will be placed over the center of the ears of the patient while the cut out front edge will be placed parallel with the eye brows.

The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert. These materials are routinely used in medical device construction and can be cleaned using mild bleach or alcohol as the customers will be instructed to do so.

The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol.

Features of the Insight Head Coil:
Imaging
. 2-channel quadrature design uses multiple elements that surround the head tissue
. Optimized for high speed imaging applications
. Compatible with Siemens and GE3T MRI systems
. High SNR
Ergonomics
. Large ID to accommodate a major percentage of patient population
. Ergonomically designed for patient comfort to minimize motion artifact
. Positioning accessories include an adjustable head support and retraction mechanism
. Attachable mirror to reduce patient claustrophobic response
. Complete lack of material in front of the patients face to reduce claustrophobic response.

AI/ML Overview

The provided document is a 510(k) summary for the Insight Head Coil, a magnetic resonance diagnostic device. It does not contain details about acceptance criteria, specific studies, or performance metrics in a way that directly addresses the requested information for AI/device performance evaluation.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use. It does not describe a study involving performance acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, or reader performance improvement.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the available information, highlighting what is not present:

Acceptance Criteria and Device Performance Study for Insight Head Coil

Based on the provided 510(k) summary, the Insight Head Coil is a hardware device (a head coil for MRI) and not an AI or software-driven diagnostic tool. Therefore, the concept of "acceptance criteria" and "device performance" in terms of diagnostic accuracy (like sensitivity, specificity) or "human reader improvement with AI" as typically applied to AI/CAD devices, is not directly applicable to this submission.

The "acceptance criteria" for this type of device primarily revolve around safety, functional equivalence to predicate devices, and the ability to produce images interpretable by a trained radiologist. The document confirms that the device meets these general criteria by demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Biologically inert materials, controlled hazards.	"The materials of construction and components are all identical to the predicate devices." "The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert." "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes."
Functional Equivalence: Ability to produce diagnostic quality MRI images of the head.	"The Insight Head Coil provides images comparable to the predicate devices." "Used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist."
Compatibility: With MRI systems.	"Compatible with Siemens and GE3T MRI systems."
Image Quality: High Signal-to-Noise Ratio (SNR).	"High SNR"
Ergonomics/Patient Features: Improved patient comfort and reduced claustrophobia.	"Ergonomically designed for patient comfort to minimize motion artifact," "Complete lack of material in front of the patients face to reduce claustrophobic response."

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The document describes a hardware device, not an algorithm requiring a "test set" in the context of diagnostic performance evaluation with patient data. The evaluation is mechanical and functional, comparing its performance to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Ground truth in the diagnostic sense (e.g., presence/absence of disease) is not established for this device, as it is a coil, not an image interpretation system. The statement "images that can be interpreted by a trained radiologist" refers to the general function of MRI images.

4. Adjudication method for the test set:

Not applicable / Not provided.

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:

No, not done. This is a hardware device (MRI coil) and not an AI or CAD system. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely outside the scope of this submission.

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

Not applicable. This device is a hardware component (MRI head coil), not an algorithm or software. Its performance is evaluated within the larger MRI system, always with a human operator and a human reader (radiologist) interpreting the resulting images.

7. The type of ground truth used:

Not applicable / Not defined in the context of diagnostic accuracy. The "ground truth" for this device relates to its physical and image-forming properties, and its ability to generate images comparable to other approved MRI coils.

8. The sample size for the training set:

Not applicable / Not provided. This is a hardware device, not an algorithm that requires a "training set" of data.

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

Not applicable / Not provided.

Summary of the Document's Approach:

The 510(k) submission for the Insight Head Coil relies on the concept of substantial equivalence to predicate devices. This means that instead of presenting a new clinical study with specific acceptance criteria related to diagnostic accuracy, the manufacturer demonstrates that their device has:

The same intended use.
Similar technological characteristics.
Raised no new questions of safety or effectiveness.

The "study" described, implicitly, is a series of tests to ensure the coil produces images comparable to existing coils, operates safely, and functions as intended within an MRI system. This would involve engineering tests, phantom imaging, and potentially some limited human subject imaging to show image quality, but without a focus on diagnostic accuracy metrics like sensitivity or specificity.

Summary

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JUN 19 2006

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.

1. Identification of Submitter:

Submitter:	Insight Neuroimaging Systems LLC
Address:	11 Canterbury St.Worcester MA 01610
Phone:	(508) 799-6464
Fax:	(508) 799-6030
Contact:	Patricia A. Milbank
Title:	Regulatory Consultant
Phone:	425-894-9733
Fax:	425-822-3648
Date Prepared:	May 5, 2006

2. Identification of Product:

Trade Name:	Insight Head Coil
Regulatory Number:	21 CFR 892.1000
Regulation Name:	Magnetic Resonance Diagnostic Device
Common Name:	Coil, Magnetic Resonance Specialty
Regulatory Class:	Class II
Product Code:	90 MOS
Manufacturer:	Insight Neuroimaging Systems LLC.11 Canterbury St.Worcester MA 01610

4. Indications for Use

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5. Device Description:

The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol.

Features of the Insight Head Coil:

Imaging

. 2-channel quadrature design uses multiple elements that surround the head tissue
. Optimized for high speed imaging applications
. Compatible with Siemens and GE3T MRI systems
. High SNR

Ergonomics

. Large ID to accommodate a major percentage of patient population
. Ergonomically designed for patient comfort to minimize motion artifact
. Positioning accessories include an adjustable head support and retraction mechanism
. Attachable mirror to reduce patient claustrophobic response
. Complete lack of material in front of the patients face to reduce claustrophobic response.

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6. Comparison with Legally Marketed Devices

The Insight Head Coil is substantially equivalent to the legally marketed devices listed below:

Model:	Magnetom Trio Head Coil
Manufacturer:	USA Instruments
510 (k) Number:	K021330
Model:	AIR Head Coil
Manufacturer:	Advanced Imaging Research
510 (k) Number:	K023929
Model:	TEM 3000 Head Coil
Manufacturer:	MR Instruments Inc.
510 (k) Number:	K040937

All of these head coils are intended for use in conjunction with a magnetic resonance scanner to produce diagnostic images of the head and neck tissues that can be interpreted by a radiologist.

The predicate devices are designed for use with various MR scanners as is the Insight Head Coil.

The Insight Head Coil is a quadrature transmit and receive coil for imaging the tissues of the head and neck. All of these head coils have an open coil design to optimize imaging of heads of various sizes.

7. Conclusions

The Insight Head Coil is substantially equivalent to the identified legally marketed devices. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Insight Head Coil provides images comparable to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

JUN 19 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Patricia A. Milbank Regulatory Consultant Insight Neuroimaging Systems LLC 11 Canterbury Street WORCHESTER MA 01610

Re: K061281

Trade/Device Name: Insight Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 5, 2006 Received: May 9, 2006

Dear Ms. Milbank:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" in it. The letters "FDA" are in large, bold font in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text, but the text is too small to read.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely vours.

Nancy C. hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication(s) for Use Statement

510(k) Number:

To be assigned by FDA

K061281

Device Name:

Insight Head Coil

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyson

(Division Sign-Off) Division of Reproductive. Ab and Radiological Devic 510(k) Numbe

Original 510(k) PreMarket Notification Insight Neuroimaging Systems LLC., Insight Head Coll

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.