The M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.

Device Description

The Wrist MRI is a 1 Tesla high-performance solution, using NdFeB magnetic material, providing routinely 250 micron or better resolution. The system is Eddy - currents free with gradients which have high strength and a fast slew rate. The Wrist MRI is designed to ensure maximum safety of operation. Its negligible external magnetic-field eliminates the need for a specially shielded room and other limiting operational procedures. The Wrist MRI system's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ASPECT IMAGING's WRIST MRI SYSTEM (K120701), based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Performance)

The document does not explicitly state quantitative "acceptance criteria" against which the device performance was measured in a table format. However, it lists several performance standards and states that the device "functioned as intended and/or met the requirements of the standard." These standards effectively serve as the acceptance criteria for the non-clinical performance.

Acceptance Criteria (Performance Standard)	Reported Device Performance
Electrical & Mechanical Safety (IEC 60601-1)	Functioned as intended and/or met the requirements of the standard.
Electromagnetic Compatibility (IEC 60601-1-2)	Functioned as intended and/or met the requirements of the standard.
Software Validation	Functioned as intended and/or met the requirements of the standard.
MR Image Quality Testing	Functioned as intended and/or met the requirements of the standard.
NEMA MS-1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging	Functioned as intended and/or met the requirements of the standard.
NEMA MS 3-2008 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images (Image Uniformity Test)	Functioned as intended and/or met the requirements of the standard.
NEMA MS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices	Functioned as intended and/or met the requirements of the standard.
NEMA MS 5-2010 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging	Functioned as intended and/or met the requirements of the standard.
NEMA MS 8 (2006) Characterization of the Specific Absorption Rate (SAR) for MRI Systems	Functioned as intended and/or met the requirements of the standard.
NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging	Functioned as intended and/or met the requirements of the standard.
NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging	Functioned as intended and/or met the requirements of the standard.
NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion for Special Applications	Functioned as intended and/or met the requirements of the standard.
IEC 60601-2-33 Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment	Functioned as intended and/or met the requirements of the standard.
High Contrast Spatial Resolution Testing	Better than 250um area pixel resolution (stated as a technical characteristic and implies acceptance of this).

Study Details:

Based on the provided document, the submission focuses entirely on non-clinical performance data and software validation to demonstrate substantial equivalence. No clinical study was conducted or reported.

Here's the information extracted given the lack of a clinical study:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable, as no clinical test set was used. Performance was assessed on the device itself against established standards.
- Data Provenance: Not applicable for clinical data. The non-clinical tests were conducted on the device components and the integrated system. The applicant is from Israel.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable, as no clinical test set requiring expert ground truth establishment was used.
Adjudication Method for the Test Set:
- Not applicable, as no clinical test set requiring adjudication was used.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Not Applicable."
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- The "device" in this case is the MRI system itself, not an AI algorithm. The performance evaluation focused on the physical and software components of the MRI system as a standalone imaging device, without human interpretation for the purpose of this submission (as it was non-clinical). So, in a sense, the non-clinical tests assess the "standalone" performance of the imaging system. However, this is not an AI algorithm evaluation.
The Type of Ground Truth Used:
- For the non-clinical performance, the "ground truth" was defined by industry performance standards (IEC, NEMA) and the device's own design specifications. The device's performance was compared against these established standards and specifications.
Sample Size for the Training Set:
- Not applicable. This is a medical imaging device (MRI system), not an AI algorithm that requires a training set in the typical sense.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no training set in the context of an AI algorithm.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on the technological characteristics and comprehensive non-clinical performance testing against recognized industry standards, and not through clinical trials or AI algorithm performance evaluation.

Summary

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K120701

510(k) Summary

510(k) SUMMARY

FEB 7 2013 -

ASPECT IMAGING's WRIST MRI SYSTEM

Applicant's Name:

Company name:	Aspect Imaging Ltd.
Address:	27 Shaked St.
	Industrial Area Hevel Modi'in
	P.O. Box 926
	Shoham, 60850
	ISRAEL
Tel:	+972-73-223-9000
Fax:	+972-3-716-5606

Contact Person:

Official Correspondent:	Ahava Stein ·
Company name:	A. Stein – Regulatory Affairs Consulting
Address:	Beit Hapaamon (Suite 213)20 Hata'as Str. (Box 124)Kfar Saba 44425Israel
Tel:	+ 972-9-7670002
Fax:	+972-9-7668534
E-mail:	ahava@asteinrac.com

Date Prepared: September 19, 2012

Name of the device: M2 Wrist MRI System

Trade or proprietary name, if applicable: Magnetic Resonance Imaging System

Common or usual name: MRI System

Establishment Registration No.: TBD

Magnetic Resonance Imaging System Classification Name:

Classification: The subject of this 510(k) is the M2 Wrist MRI System, with the CFR classification sections 892.1000; Magnetic Resonance Imaging System with product code LNH.

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Predicate Devices:

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

The M2 Wrist MRJ System is substantially equivalent to the Orthone MRI System (manufactured by Oni Inc. and the subject of 510(k) K001773). A comparison table and detailed discussion are presented in Section 12 of this application.

Intended Use:

The M2 Wrist MRI System is intended for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.

Technological Characteristics:

The Wrist MRI is designed to ensure maximum safety of operation. Its negligible external magnetic-field eliminates the need for a specially shielded room and other limiting operational procedures.

The Wrist MRI system's main components are:

Magnet Sub-system ■
I Wrist Coil
l Electronics Cabinet
Aspect Imaging Proprietary Software 에
Computer
· Isolation Transformer

Technical Description of magnet subsystem:

Field strength: 1.05 +/- 2% Tesla vertical Field, horizontal bore 트
Bore opening size(H x W) 76 x 200 mm ■
트 Magnet size: approx. 79 x 79 x 114 cm
approx. 930 kg 트 Magnet weight:
Passive B0 shim system ■
Field of View - 115 x 80 x 50 mm
Resolution Better than 250um area pixel 트

Technical Description of gradient system:

Type: Special purpose gradient system
No Eddy current 트
Gradient strength: 190 mT/m 트
1 Slew rate: 400 T/m/sec

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Comparison of Technological Characteristics with the predicate device:

The M2 Wrist MRI System has the same technological characteristics as the predicate device, i.e., the Orthone MRI System. Both devices contain the same basic components consisting of a magnet, a coil, a separate electronic cabinet or unit containing a control unit, a RF power amplifier, gradient amplifier, power distribution unit, and spectrometer. Furthermore, both devices contain a computer PC component and system software. Both the M2 MRJ Wrist System and the Orthone MRI System are large devices with similar large dimensions and weight, although both of them a relatively compact MRI Systems as they are intended for small body parts as opposed to full body MRI systems.

The component specifications are comparable between the new MRI device and the predicate device. Both MRI devices use a 1 Tesla magnet as the basic scientific technology of the device. The basic device performance of the M2 Wrist MRJ System and the Orthone MRI System are similar. There are some minor differences between the M2 Wrist MRI System and the Orthone MRI System, including slice thickness.

Though there are some minor differences in the characteristics of the two systems, these differences do not raise new questions of safety or efficacy. Furthermore, the M2 Wrist MRI System has passed all the required tests and standards for MRI devices, as did the Orthone MRI System. These tests include compliance with electrical and mechanical safety according to IEC 60601-1, electromagnetic compatibility according to IEC 60601-1-2 and specific testing for MRI devices according to the IEC 60601-2-33 and testing according to the applicable NEMA standards.

Non-Clinical Performance Data:

See Performance Standards

Performance Standards:

The following performance tests were performed on the M2 Wrist MRI System or its components:

Electrical & Mechanical Safety (IEC 60601-1) .
트 Electromagnetic Compatibility (IEC 60601-1-2)
트 Software Validation
트 MR Image Quality Testing
NEMA MS-1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic . Magnetic Resonance Imaging
NEMA MS 3-2008 Determination of Two-Dimensional Geometric Distortion in I Diagnostic Magnetic Resonance Images (Image Uniformity Test)
NEMA MS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing ■ Magnetic Resonance Imaging Devices

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NEMA MS 5-2010 Determination of Slice Thickness in Diagnostic Magnetic . Resonance Imaging
NEMA MS 8 (2006) Characterization of the Specific Absorption Rate (SAR) for . MRI Systems
NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in ■ Diagnostic Magnetic Resonance Imaging
NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in ■ Diagnostic Magnetic Resonance Imaging
NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion for Special Applications
IEC 60601-2-33 Medical electrical equipment Part 2-33: Particular requirements I for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic (2007 (Second Edition) + A1:2005 + A2:2007)
High Contrast Spatial Resolution Testing .

In all instances, the M2 Wrist MRI System functioned as intended and/or met the requirements of the standard.

Clinical Performance Data:

Not Applicable

Conclusions Drawn from Non-Clinical and Clinical Tests:

The performance tests demonstrate that M2 Wrist MRI System may be safely and effectively used in acquiring wrist MR images. The software validation and performance tests demonstrate that the M2 Wrist MRI System meets its design and performance specifications and is substantially equivalent to the cleared Orthone MRI System.

Substantial Equivalence:

In summary, the indications for use of the M2 Wrist MRI System are substantially equivalent to the Orthone MRI system. Furthermore, the basic technological characteristics of the M2 Wrist MRI System are similar to the Orthone MRI System. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the M2 Wrist MRI System is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 7, 2013

Aspect Imaging Ltd. c/o Ms. Ahava Stein Regulatory Consultant 20 HATA'AS ST (BOX 124) KFAR SABA 44425 ISRAEL

Re: K120701

Trade/Device Name: M2 Wrist MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: January 20, 2013 Received: January 25, 2013

Dear Ms. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we have teviewed your Section 3 re(i) pe 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 American Co., Continents, or to commerce provision way 20, 1976, the enaonance with the provisions of the Federal Food, DDVA A and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costience Act (Act) that do not require approval controls provisions of the Act. The r ou may, ulcretore, manot the Act include requirements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Tease note: ODICP assess that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (300 above) in Existing major regulations affecting your device can be It may be subject to additions, 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 and of the other Flease be advised that I Dris issuance of or device complies with other requirements of the Act that I DA has made a decertifications administered by other Federal agencies. You must or ally it ederal statures and regulations and limited to: registration and listing (21 comply with an the Act 31equirements, montals, medical device reporting (reporting of medical Cr K Fall 607), labeling (21 OFR 803); good manufacturing practice requirements as set

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Page 2-Ms. Stein

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 Part 801), please 11 you desire specific advisoutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

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

Enclosure

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Indications for Use Form

510(k) Number (if known): K120701 Device Name: M2 Wrist MRI System

Indications for Use:

The M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for The MZ Wrist MIKI System is indicated for assess of the internal structure of the wrist (in patients producing transverse, sagital and coronal mages of attained physician, the resultant MR images with an arm length - 520cm
provide information that can be useful in determining a diagnosis.

Prescription Use V (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 OF NEEDED)

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

Michael D. O'Hara

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

510(k) K120701

Page i of I

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.