The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.

Device Description

The SENSE Head-Spine-Torso (HST) MR Coil System includes 16 channel coil components that are designed for use with Philips 16-Channel 1.5T Magnetic Resonance Imaging (MRI) magnet systems. The coils work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coils may receive the resultant RF signal from the excited nuclei. The coils are receive-only coils for high resolution imaging of thorax (including heart), abdomen, cervical, lumbar, and thoracic regions of the spine and the head, neck regions. The coils provide unilateral images of the anatomy of interest. The SENSE HST coils are designed to be used together and separately as follows:

Coil Models	Comments
Head + Spine + Torso	All three coils may be used together.
Head + Spine	Head Coil does not function unless it is connected to the Spine Coil.
Spine + Torso	Spine and Torso may be used together without the Head Coil
Spine	Spine Coil may be used alone.

AI/ML Overview

The provided text describes a 510(k) submission for the SENSE Head-Spine-Torso (HST) MR Coils. The information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic AI algorithm.

Therefore, many of the requested categories (sample size, experts, adjudication, MRMC, training set, etc.) are not applicable or not provided in the typical sense of a clinical performance study for an AI device. The submission primarily relies on non-clinical engineering and safety tests.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for clinical performance in terms of sensitivity, specificity, accuracy, or similar metrics typically associated with AI diagnostic devices. Instead, it describes compliance with established engineering and safety standards as evidence of substantial equivalence.

Acceptance Criteria Category	Reported Device Performance / Assessment
Non-Clinical Testing Standards (per FDA Guidance)
Signal to Noise Ratio (SNR)	Performed as per NEMA MS 1-2008. (Specific performance values not provided, but implies satisfactory results for substantial equivalence.)
Image Uniformity	Performed as per NEMA MS 3-2008. (Specific performance values not provided, but implies satisfactory results for substantial equivalence.)
Characterization of Phased Array Coils (Image Quality)	Performed as per NEMA MS 9-2008. DICOM files from the subject device were reviewed by a radiologist who confirmed the image quality is suitable for clinical applications. (Specific performance metrics for image quality not provided, but expert qualitative assessment indicates suitability.)
IEC 60601 Safety Evaluation	Conformance to IEC 60601-1 (General Requirements for Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-2-33 (Particular Requirements for Safety of MR Equipment). (Implies successful completion of these safety tests, ensuring the device meets established safety profiles for medical electrical equipment and MR systems. Specific pass/fail criteria or quantitative safety metrics are not detailed in this summary.)
Comparison to Predicate Device
Design Rationale	Substantially equivalent
Safety Features	Substantially equivalent (e.g., electrical isolation, housing material flammability rating UL94-HF-1 for Polycarbonate, Polyethylene)
Magnet System Compatibility	Substantially equivalent (Philips 1.5T MRI Systems)
Overall Intended Use	Substantially equivalent (Accessory to MRI Scanner, same FDA class II product code MOS, receive-only coils, 1.5T systems compatibility, multi-pin connector)

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

This is not a study measuring diagnostic performance on a patient test set in the traditional sense; it's a device submission for MR coils.

Test Set Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The "testing" involved phantoms for SNR, uniformity, and coil characterization, as well as qualitative review of DICOM images by a radiologist. The number of phantoms or images reviewed is not specified.
Data Provenance: Not applicable for patient data. The tests were primarily engineering and safety evaluations, likely conducted in a lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: One radiologist is mentioned: "DICOM files from the 510(k) subject device were reviewed by a radiologist who confirmed the image quality is suitable for clinical applications."
Qualifications of Experts: Only "radiologist" is specified. Further details (e.g., years of experience, subspecialty) are not provided in this summary.
Ground Truth Establishment: For the qualitative image quality assessment, the single radiologist's confirmation of "suitability for clinical applications" served as the expert assessment.

4. Adjudication Method for the Test Set

Not applicable. Only one expert is mentioned for qualitative image review, so no adjudication process between multiple readers was necessary or stated.

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 not an AI device or a comparative effectiveness study involving human readers. It's a submission for MR coils.

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

Not applicable. This is not an AI algorithm. The device itself (MR coil) is an accessory that generates images, and its "performance" is primarily defined by image quality characteristics and electrical/mechanical safety, rather than a diagnostic output.

7. The Type of Ground Truth Used

For engineering metrics (SNR, Uniformity): Phantoms and established measurement protocols (NEMA standards) serve as the "ground truth" for these quantifiable technical specifications.
For qualitative image quality: Expert opinion (judgment of the single radiologist) on suitability for clinical applications.
For safety: Compliance with IEC standards derived from established safety requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that undergoes training.

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

Not applicable.

Summary

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K122897.

510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils

Submitted By:	Invivo Corporation3545 SW 47th AvenueGainesville, FL 32608	DEC 21 2012
Date:	December 20, 2012
Contact Person:	Lance Aulabaugh, Quality EngineerTel: (352) 336-0010, ext. 156 Fax: (352) 336-1410
Proprietary Name:	SENSE Head-Spine-Torso MR Coil System:SENSE Spine 16SENSE Head 16SENSE Torso 16
Common Name:	Coil, Magnetic Resonance, Specialty
Classification Name and Reference:	21 CFR 892 1000

A magnetic resonance diagnostic device, 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, class II.

Device Product Code and Panel Code: MOS / Radiology / 90

Indications for Use:

The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.

Device Description:

Coil Models	Comments
Head + Spine + Torso	All three coils may be used together.
Head + Spine	Head Coil does not function unless it is connected to the Spine Coil.
Spine + Torso	Spine and Torso may be used together without the Head Coil
Spine	Spine Coil may be used alone.

Section 005 Page 1 of 3

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510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils

Substantial Equivalence Discussion:

When compared to the predicate devices, the SENSE Head-Spine-Torso system is substantially equivalent to the 1.5T 8-Channel Medium General Purpose Flex Coil (K093842, clearsd March 5, 2010). Substantial equivalence is based on design rationale, safety features, magnet system. compatibility and overall intended use. The indications for use statements differ with respect to the target anatomies; however, the predicate and new device system both fall within the same FDA class II product code, MOS and have the same fundamental intended use. I.ille the predicate, the proposed devices are receive-only MRI coils that are designed for use with Philips 1.5T magnet systems. The electrical isolation methods, decoupling method and housing material flammability ratings are the same for the predicate and new device.

	PREDICATE	NEW DEVICE

Type of Device(FDA Product Code)	1.5T 8-Channel MediumGeneral Purpose Flex CoilK093842Accessory to MRI Scanner(MOS)	SENSEHead-Spine-TorsoSystemAccessory to MRI Scanner(MOS)
Indications for Use	The coil is indicated for use onthe order of a physician, inconjunction with Philips 1.5Tand 3.0T MR scanners as anaccessory to produce imagesof the hip, knee, ankle, chest,and pelvic regions, as an aid todiagnosis.	The coils are indicated for useon the order of a physician, inconjunction with Philips 1.5TMR scanners as accessories toproduce images of the head,spine and torso.
Target Anatomies	hip, knee, ankle, chest, andpelvic regions	head, spine and torso regions
System Compatibility	Philips 1.5T MRI Systems	Philips 1.5T MRI Systems
Type of Coil	Receive-Only	Receive-Only
Number of Channels	8 Channels	16 Channels
Decoupling Method	LC Tank Circuit	LC Tank Circuit
Electrical Isolation	Plastic housing with foaminsulation	Plastic housing with foaminsulation
Housing Materials &Flammability Rating	PolycarbonatePolyethyleneRating: UL94-HF-1	PolycarbonatePolyethyleneRating: UL94-HF-1
Type of MRI System	Standard	Standard
Connector	Multi-pin Connector	Multi pin Connector

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510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils

Summary of Non-Clinical Tests for Substantial Equivalency Determination:

Per Guidance for Industry: Guidance for the Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices', the following preclinical testing was performed per the standards listed below and supports substantial equivalency to the predicate device: Signal to Noise Ratio (SNR)2, Image Uniformity3, Characterization of for Diagnostic MR Images and IEC 60601 safety evaluation . DICOM files from the 510(k) subject device were reviewed by a radiologist who confirmed the image quality is suitable for clinical applications.

Standards Referenced:

1. Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices Issued On November 14, 1998
1. NEMA Standards Publications MS 1-2008: Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
1. NEMA Standards Publications MS 3-2008: Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
1. NEMA Standards Publications MS 9-2008: Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
1. IEC 60601 Standards:

IEC 60601-1, 1988; Medical Electrical Equipment - Part 1: General Amendment 1, 1991-11, Requirements for Safety Amendment 2, 1995. IEC 60601-1-2: 2001 Medical Electrical Equipment - Part 2: General Edition 2:2001 with Requirements for Safety Collateral Standard: Electromagnetic Compatibility-Requirements and Amendment 1:2004; Edition 2.1 (Edition:2001 consolidated with Tests Amendment 1:2004) IEC 60601-2-33: 2002 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Magnetic Resonance Amendment 1:2005 Equipment for Medical Diagnosis

Substantial Equivalency Conclusion:

Based on a comparison of technological characteristics, conformance to safety standards preclinical test results, the SENSE Head-Spine-Torso MR coil system is substantially equivalent to the 1.5T 8-Channel Medium General Purpose Flex Coil cleared via K093842.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a sans-serif font and is arranged to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 21, 2012

INVIVO CORP % Mr. Lance Aulabaugh Quality Engineer 3545 SW 47th Avenue Gainesville, FL 32608

Re: K122897

Trade/Device Name:

SENSE Head-Spine-Torso MR Coil System: SENSE Head 16 SENSE Spine 16 SENSE Torso 16

Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: December 6, 2012 Received: December 7, 2012

Dear Mr. Aulabaugh:

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. Iisting 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 (PMA), it may be subject to 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.

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

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Page 2 - [Contact Person's Name]

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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510(k) Number (if known): K122897

Device Name: SENSE Head 16, SENSE Spine 16, SENSE Torso 16

Indications for Use: The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Janine M. Morris -S 2012.12.21 16:26:13 -05'00'

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K122897 510(k):

Section 004 Page 1 of 1

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.