The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The Wrist 3 MRI System is a 1Tesla Permanent MRI system producing MR images of the wrists and hands. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Aspect Imaging Wrist 3 MRI System. It primarily focuses on demonstrating substantial equivalence to a predicate device (M2 Wrist 2 MRI System K130692) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel diagnostic algorithm.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the Wrist 3 MRI System in terms of diagnostic accuracy, sensitivity, specificity, or other outcome-based measures. The evaluation is based on demonstrating compliance with voluntary consensus standards and comparing technical specifications to the predicate device.

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (Summary of Technical Comparison)
Compliance with Safety and Performance Standards	Tested to comply with IEC/ES 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS-1, NEMA MS-3, NEMA MS-2, NEMA MS-12, NEMA MS-5. System and Software verification and Validation testing performed.
Image Production Capability	Intended for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. This is an expansion of the predicate device's capability which listed only transverse, sagittal and coronal images of the wrist.
Diagnostic Utility	Images, when interpreted by a trained physician, provide information useful in determining a diagnosis. (This is a statement of intended use rather than quantitatively measured performance).
Substantial Equivalence to Predicate	Technology: Employs the same fundamental scientific technology (1 Tesla Permanent MRI system) as the predicate (M2 Wrist 2 MRI System K130692). Intended Use/Indication for Use: Expanded to include "Hand" and "oblique" images in addition to "Wrist," "axial, sagittal, coronal." Patient Population: Expanded to "Wrist and Hand." Anatomical Sites: Expanded to "Wrist and Hand." Environment of Use: Hospital or clinical setting (same). Energy Used: Magnetic Resonance (same). Human Factors: Designed similar to other commercially available MRI Systems, user-friendly software interface (same claim). Hardware Changes (Wrist 3 vs. M2 Wrist 2): - Magnet Physical Dimensions: 138x87x82 cm (vs. 125x87x82 cm) - Bore opening: 85x220 mm (vs. 76x200 mm) - Weight: 1300 Kg (1700 with Trolley) (vs. 1050 Kg) - Field Strength: 1 Tesla Permanent Magnet (same). - Gradient Strength: 215 mT/m (vs. 190 mT/m) - Gradient Rise Time: 0.200mSec (vs. 0.475mSec) - Gradient Slew Rate: 1074 T/m/Sec (vs. 400 T/m/Sec) - Computer Display: 15" Touch Display (vs. 24" LCD Desktop Display) - RF Coils: 2 Coils: Small/Large (vs. 1 Coil) - Coil Type: TX/RX (same) - Coil Geometry: Oval (same) - Inner Dimensions (mm): 60X100X169 / 75X135X192 (vs. 50X108X86) - Coil Design: Linear Volume (same).

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

The document states, "The subject of this premarket submission, Wrist 3 MRI System, did not require clinical studies to support substantial equivalence." It mentions "Sample clinical images" were part of the design controls activity, but does not provide details on their sample size, provenance, or whether they constituted a formal "test set" for performance evaluation against ground truth.

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, as no formal clinical study with a detailed test set and ground truth establishment is described. The "sample clinical images" used were likely for qualitative assessment as part of design validation, but the ground truth establishment method and expert details are not provided.

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

Not applicable, as no formal clinical test set or adjudication process 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. This device is an MRI system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is a medical imaging device, not an image analysis algorithm designed for standalone performance.

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

Not applicable, as no formal clinical study with ground truth establishment is described.

8. The sample size for the training set:

Not applicable, as this is an MRI system, not an AI model that requires a training set in the conventional sense.

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

Not applicable, as this is an MRI system, not an AI model that requires a training set.

Summary

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

March 1, 2016

Aspect Imaging Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K160185

Trade/Device Name: Wrist 3 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: February 22, 2016 Received: February 23, 2016

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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), 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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

510(k) Number (if known) K160185

Device Name Wrist 3 MRI System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a stylized cube made up of three layers in shades of blue, green, and yellow. To the right of the cube is the company name, "aspectimaging," written in a sans-serif font, with the "t" in "aspect" stylized to resemble a plus sign.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	February 16, 2016
Submitter:	Aspect Imaging Ltd.
	27 Shaked St.
	Industrial Area Hevel Modi'in
	P.O. Box 926
	Shoham, 6085001
	ISRAEL
Primary Contact Person:	Israel A. Citron
	VP Quality Assurance and Regulatory Affairs
	Aspect Imaging LTD
	Tel: +972-73-223-9000 Ext 90
	Fax: +972-3-716-5606
	E mail: icitron@aspectimaging.com
Device Trade Name:	Wrist 3 MRI System
Common/Usual Name:	MRI System
Product Classification	II
Classification Name:	Magnetic Resonance Diagnostic Device (21 CFR 892.1000)
Product Code:	LNH, MOS
Predicate Device(s):	K130692 M2 Wrist 2 MRI System
Device Description:	The Wrist 3 MRI System is a 1Tesla Permanent MRI systemproducing MR images of the wrists and hands. During MRI scan,body parts to be imaged are held within a uniform static magneticfield, and are subject to sequences of RF pulses and gradientmagnetic fields. The signal from the precession of themagnetization created by these fields is sampled and processed toproduce image data.
Intended Use:	The Wrist 3 MRI System is intended for use as a magneticresonance imaging device for producing axial, sagittal, coronal,and oblique images of the internal structure of the Wrist and Hand.When interpreted by a trained physician, these images provideinformation that can be useful in determining a diagnosis
Technology:	The Wrist 3 MRI System employs the same fundamentalscientific technology as its predicate device (M2 Wrist 2 MRISystem K130692).
Comparison ofSpecifications	Predicate DeviceM2 Wrist 2 MRI System(K130692)	Proposed DeviceWrist 3 MRI System
Intended Use/Indication for Use	The M2 Wrist II MRI Systemis indicated for use as amagnetic resonance imagingdevice for producing transverse,sagittal and coronal images ofthe internal structure of the wrist(in patients with an arm length >320 mm). When interpreted by atrained physician, the resultantMR images provide informationthat can be useful in determininga diagnosis.	The Wrist 3 MRI System isintended for use as a magneticresonance imaging device forproducing axial, sagittal,coronal, and oblique images ofthe internal structure of theWrist and Hand. Wheninterpreted by a trainedphysician, these images provideinformation that can be useful indetermining a diagnosis.
Patient Population	Patients requiring MR images of thewrist	Patients requiring MR images of thewrist and Hand
Anatomical Sites	Wrist	Wrist and Hand
Environment of Use	Hospital or clinical setting	Hospital or clinical setting
Energy Used and/or delivered	Magnetic Resonance	Magnetic Resonance
Human Factors	The M2 Wrist 2 MRI System isdesigned similar to othercommercially available MRISystems and therefore is familiarand easy for use for the user.Furthermore, the device contains auser-friendly software interfacethrough which the user may easilyaccess all device functions.	The Wrist 3 MRI System isdesigned similar to othercommercially available MRISystems and therefore is familiarand easy for use for the user.Furthermore, the device contains auser-friendly software interfacethrough which the user may easilyaccess all device functions.
Hardware Changes
Magnet:
- Physical Dimensions	125x87x82 cm	138x87x82 cm
- Bore opening	76x200 mm	85x220 mm
- WeightField StrengthGradient:	1050 Kg1 Tesla Permanent Magnet	1300 (1700 with Trolley) Kg1 Tesla Permanent Magnet
-Strength	190 mT/m	215 mT/m
-Rise Time	0.475mSec	0.200mSec
-Slew Rate	400 T/m/Sec	1074 T/m/Sec
Computer:
-Display:	24" LCD Desktop Display	15" Touch Display
RF Coils	1 Coil	2 Coils: Small/Large
Coil Type	TX/RX	TX/RX
Coil Geometry	Oval	Oval
Inner dimensions (mm)	50X108X86	60X100X169 / 75X135X192
Coil Design	Linear Volume	Linear Volume

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Image /page/4/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a teal and green geometric shape on the left, followed by the word "aspectimaging" in a dark purple sans-serif font. The geometric shape appears to be a stylized representation of a cube or layered structure.

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Image /page/5/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a geometric shape on the left and the text "aspectimaging" on the right. The geometric shape is made up of four stacked squares, each a different color: blue, green, yellow, and purple. The text "aspectimaging" is written in a sans-serif font, with "aspect" in purple and "imaging" in gray.

Determination of Substantial Equivalence:

Summary of Nonclinical Testing:

The Wrist 3 MRI System and its applications were tested to comply with the below voluntary consensus standards.

IEC/ES 60601-1
IEC 60601-1-2
트 IEC 60601-2-33
트 NEMA MS-1
NEMA MS-3
트 NEMA MS-2
NEMA MS-12
NEMA MS-5

In addition System and Software verification and Validation testing were performed to demonstrate performance of the device as part of design controls activity.

The following design control activities were applied to the development of the system:

Risk Management
Requirements Management
Design Reviews
트 Unit level module verification
트 System Integration verification
I Performance verification
Safety and EMC testing
I Simulated use validation testing
Sample clinical images

Summary of Clinical Tests:

The subject of this premarket submission, Wrist 3 MRI System, did not require clinical studies to support substantial equivalence.

Conclusion: Based on bench testing and sample clinical images. Aspect Imaging LTD believes that the Wrist 3 MRI System is substantially equivalent to its predicate device.

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.