The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 System is intended to support, supplement and/or augment the performance of the Siemens Magnetom Skyra, Siemens Magnetom Prisma, Philips Achieva and GE Signa Premier scanners.

Device Description

The TCL3 Motion Tracking System monitors the patient's head for the scan. It can be turned off between patient scans. While running, the TCL3 Motion Tracking System continuously scans the surface of the patient's head, producing high-resolution 3D surfaces consisting of thousands of individual points. A structured light technique is utilized, using the combination of a camera and an infrared light modulator to reconstruct 3D surfaces of the patient's head. Each second, 30 surfaces are created. Each of these surfaces is used for geometric alignment relative to an initial reference position obtained at the beginning of the scan. From these alignments, motion data can be calculated in real-time.

AI/ML Overview

The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner that uses markerless sensor-based technology to track patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (TCL3 Motion Tracking System)	Notes from Comparison with Predicate
Translational Accuracy	200 μm	Predicate device (KinetiCor Motion Correction System) reported 100 μm. This is a difference highlighted in the comparison table.
Rotational Accuracy	0.2 degrees	Predicate device reported 0.1 degrees. This is a difference highlighted in the comparison table.
Recording Rate	30 frames per second	Predicate device reported 60 frames per second. This is a difference highlighted in the comparison table.
MRI Scanner Compatibility	Siemens MAGNETOM Prisma 3T, Siemens MAGNETOM Skyra 3T, Philips Achieva 3T, GE Signa Premier 3T	This expands upon the predicate device's compatibility (Siemens MAGNETOM Skyra 3T only).
Core Technology	Markerless sensor-based technology, uses one camera and one infrared light modulator to identify and track a surface.	Predicate device uses at least two cameras to identify and track a physical marker. This is a key technological difference.
Line of Sight	Line of sight for the camera and infrared light modulator to the patient.	Predicate device required line of sight for two cameras to the marker.
Powering	Battery, >8 hours	Predicate device used plug-in power.
Cross Calibration Procedure	Iteratively adapting	Predicate device required at least once per month.
Electrical and Mechanical Safety	Met applicable standards (IEC 60601-1)	Verified and validated through bench testing.
Electromagnetic Compatibility (EMC)	Met applicable standards (IEC 60601-1-2)	Verified and validated through bench testing.
Software Life-cycle Processes	Met applicable standards (IEC 62304)	Verified and validated through software testing, including off-the-shelf software and cybersecurity.
Risk Management	Applied ISO 14971 standards, risks analyzed, mitigations implemented and tested.	Overall risk management was performed.
MR Compatibility	Met requirements	Verified and validated through bench testing.
Mechanical Compatibility	Met requirements	Verified and validated through bench testing.

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

The document does not explicitly state a sample size for a "test set" in the context of clinical studies on human subjects. The performance evaluations described are primarily bench testing and technical verifications/validations.

The document mentions that "Clinical data was not required for this type of device." This implies that the performance data does not originate from a clinical trial with a traditional patient test set.

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

Since "Clinical data was not required" and the testing primarily involved bench tests and technical verifications, the concept of "ground truth" as established by medical experts for a diagnostic performance study does not directly apply here. Instead, ground truth would refer to established engineering specifications and measurements. The document does not specify the number or qualifications of engineers or technicians who performed the bench testing and verified the technical specifications.

4. Adjudication Method for the Test Set

Given the nature of the testing (bench testing, technical verification, and validation) and the statement that "Clinical data was not required," there was no adjudication method described for a clinical test set, as no such clinical test set was used.

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

No MRMC comparative effectiveness study was done or reported. The document explicitly states, "Clinical data was not required for this type of device." Therefore, there is no information about the effect size of how much human readers improve with AI vs without AI assistance.

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

The device is described as an "accessory to a Magnetic Resonance Imaging (MRI) scanner" that "provides the current position of the patient in real-time to the MRI scanner." This implies that the device is continually active and providing data to the MRI system itself during a scan, rather than acting as a standalone diagnostic tool that a human would then interpret.

The performance data focuses on the accuracy and reliability of the motion tracking algorithm itself (e.g., translational accuracy, rotational accuracy, recording rate), as measured through bench testing. This can be interpreted as a form of standalone performance evaluation for its core function (motion tracking and data provision to the scanner), but not in the context of a diagnostic standalone performance where an algorithm generates a finding for human review.

7. The Type of Ground Truth Used

For the technical performance metrics (translational accuracy, rotational accuracy, recording rate, MR compatibility, etc.), the ground truth would have been established through calibrated measurement instruments and established engineering standards in a bench testing environment. The document implies that these were objectively measurable parameters against which the device's output was compared.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning. The TCL3 Motion Tracking System uses "markerless sensor-based technology" and "structured light technique," which suggests an algorithmic approach. However, there's no information provided about any machine learning training data or its size.

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

Since no training set for machine learning is mentioned, there is no information provided on how ground truth for a training set was established.

Summary

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April 28, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TracInnovations ApS % Sheila Pickering Ph.D. Consultant Sheila Pickering PhD 2081 Longden Circle LOS ALTOS CA 94024

Re: K203451

Trade/Device Name: TCL3 Motion Tracking System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: April 8, 2021 Received: April 12, 2021

Dear Dr. Pickering:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K203451

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) not known

Device Name

TCL3 Motion Tracking System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K203451) Prepared April 08, 2021

Sponsor:	TracInnovationsWorld Trade Center,Borupvang 3,DK-2750 BallerupDenmark
Contact Person:	Stefan Glimberg
Telephone:	+45 61 66 89 69
Submission Date:	November 18, 2020
Device Name:	TCL3 Motion Tracking System
Common Name:	Magnetic Resonance Diagnostic Device (MRDD)
Trade Name:	TCL3 Motion Tracking System
Classification:Regulatory Class:Review Category:	II21CFR 892.1000 (LNH)
Classification Panel:	Radiology

A. Legally Marketed Predicate Devices

The predicate device is the Motion Correction System (K193324) manufactured by KinetiCor, Inc.

B. Device Description:

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C. Intended Use / Indications for Use

The TCL3 System is intended to support, supplement and/or augment the performance of the Siemens Magnetom Skyra, Siemens Magnetom Prisma, Philips Achieva and GE Signa Premier scanners.

D. Substantial Equivalence

The TCL3 Motion Tracking System is substantially equivalent to the KinetiCor Motion Correction System (K193324).

Device Name	Predicate Device	Subject Device
	Motion Correction System manufactured by KinetiCor (K193324)	TCL3 Motion Tracking System manufactured by TracInnovations
Indications for Use	The Motion Correction System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system is a sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner for further data processing. User: Professional Use Environment: Hospital, doctor's office, or any facility that uses an MRI device. KinetiCor defines the Motion Correction System as an accessory to a medical device. It is intended to support, supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.	The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 System is intended to support, supplement and/or augment the performance of the Siemens Magnetom Skyra, Siemens Magnetom Prisma, Philips Achieva and GE Signa Premier scanners.
Intended Users	Professional Use Environment: Hospital, doctor's office, or any facility that uses an MRI device.	Professional Use Environment: Hospital, doctor's office, or any facility that uses an MRI device.
Manufacturer	KinetiCor, Inc	TracInnovations
Regulation medical specialty	Radiology	Radiology
Product code	LNH	LNH
Regulation number	892.1000	892.1000
Regulation description	Magnetic resonance diagnostic device	Magnetic resonance diagnostic device
Classification	II	II
	Predicate Device: KinetiCor,Motion Correction System(K193324)	Subject Device: TracInnovations,TCL3 Motion Tracking System
Core Technology	KinetiCor defines the MotionCorrection System as an accessoryto a medical device. It is intended tosupport, supplement and/or augmentthe performance of the scannersindicated below.	TracInnovations defines its TCL3 MotionTracking System as an accessory to amedical device. It is intended to support,supplement and/or augment theperformance of the scanners indicatedbelow.
Marker required	Yes. Requires attachment of markerto the nose bridge of the patient	No. Attachment of a marker is not required
Data acquisitionsensor	Use at least two cameras out of fourto identify a marker and then trackthe marker. Use infrared light toilluminate the marker.	Use one camera and one infrared lightmodulator (projection of structured lightpatterns) to identify and track a surface.
Line of sight	Line of sight for two cameras to themarker	Line of sight for the camera and infraredlight modulator to the patient
MRI scannercompatibility	Siemens MAGNETOM Skyra 3T	Siemens MAGNETOM Prisma 3TSiemens MAGNETOM Skyra 3TPhilips Achieva 3TGE Signa Premier 3T
Scanner borecompatibility	60 cm and 70 cm bore systems	60 cm and 70 cm bore systems
Scanner mounting	In-bore attachment, Fixed	Attachment on the scanner table,Detachable
Communicationwith scanners	Ethernet connection	Ethernet connection, UDP/IP protocol
Powering	Plug-in	Battery, >8 hours
Motion tracking	Tracks motion of the head in 6degrees of freedom (x,y,ztranslations, and rotations)	Tracks motion of the head in 6 degrees offreedom (x,y,z translations, and rotations)
Translationalaccuracy	100 μm	200 μm
Rotationalaccuracy	0.1 degrees	0.2 degrees
Recording rate	60 frames per second	30 frames per second
Cross calibrationprocedure	At least once per month	Iteratively adapting

Table 1. Substantial Equivalence Comparison of Indications for Use

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Table 2. Substantial Equivalence Comparison for Technological Characteristics

Based on the comparison of indication for use and technological characteristics, the subject device is substantially equivalent to the predicate device. Based on the performance data provided in the submission the differences do not introduce new issues related to safety and efficacy.

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E. Performance Data

Each specification of the TCL3 Motion Tracking System has been verified and validated as required by the risk analysis. All design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

ISO 14971	Application of risk management to medical devices
IEC 60601-1	Medical electrical equipment- General requirements for basic safety andessential performance
IEC 60601-1-2	Electromagnetic disturbances
IEC 62304	Medical device software - Software life-cycle processes

The verification and validation testing included testing to the following applicable standards:

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:

1. Bench testing for electrical and mechanical safety in compliance with the standards cited above
Bench testing for EMC in compliance with the standard cited above 2.
1. Software testing, consisted of verification and validation testing in compliance with ISO 62304, including test cases related to off the shelf software, as well as cybersecurity features and wireless coexistence.
1. Bench testing for tracking quality and accuracy, MR compatibility and Mechanical compatibility

Clinical data was not required for this type of device.

F. Conclusion

Potential risks were identified according to the ISO 14971 Standards. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, the performance data demonstrated that these did result in any new issues of safety or efficacy.

Therefore, the TCL3 Motion Tracking System is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.

Regulation Number and Section

N/A