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 Motion Tracking System is intended to support, supplement, and/or augment the performance of MRI scanners that have been validated for compatibility.

Device Description

The TCL3 Motion Tracking System monitors the patient's head for the duration of 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. The system is intended for use with performance tested scanners. The modified device includes a revised indications for use and an update to the system components and system software.

AI/ML Overview

The provided text describes the regulatory clearance of the TracInnovations TCL3 Motion Tracking System (K221785) as substantially equivalent to its predicate device (K203451). However, the document does not contain the specific details required to answer all parts of your request, particularly regarding acceptance criteria tied to detailed performance metrics beyond general accuracy values, and the setup of specific clinical or comparative effectiveness studies.

The information provided indicates that the device is a Motion Tracking System accessory for MRI scanners. Its primary function is to track patient movement in real-time, specifically the head, in 6 degrees of freedom.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Translational accuracy" and "Rotational accuracy" as technological characteristics, which can be inferred as performance metrics. The specific "acceptance criteria" are not explicitly stated as target values, but the reported performance values from the predicate device are listed as "identical" for the subject device.

Performance Metric	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance
Translational Accuracy	200 μm	200 μm
Rotational Accuracy	0.2 degrees	0.2 degrees
Recording Rate	30 frames per second	30 frames per second

Limitations: The text refers to "predetermined acceptance criteria were met" for verification and validation testing, but these criteria are not explicitly detailed with numerical thresholds beyond the above technological characteristics.

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

The document states: "Clinical data was not required for this type of device."
Therefore, there is no information provided on:

Sample size used for a clinical test set.
Data provenance (e.g., country of origin, retrospective/prospective).

The performance data mentioned pertains to "bench testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since "Clinical data was not required," there is no information provided on experts used to establish ground truth from clinical cases. The ground truth for bench testing would typically be established by calibrated instruments.

4. Adjudication Method for the Test Set

As no clinical test set requiring expert interpretation is described, there is no information provided on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

The document states: "Clinical data was not required for this type of device." Therefore, no MRMC comparative effectiveness study was performed or described in this document. The device is an accessory that feeds data to the MRI scanner, intending to "support, supplement, and/or augment" its performance, rather than an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device itself is a motion tracking system. Bench testing was performed for "tracking quality and accuracy," which represents the standalone performance of the algorithm and hardware in detecting motion.

The reported standalone performance (from the table above) for the motion tracking accuracy is:

Translational Accuracy: 200 μm
Rotational Accuracy: 0.2 degrees
Recording Rate: 30 frames per second

7. Type of Ground Truth Used

For the bench testing of tracking quality and accuracy (as clinical data was not required), the ground truth would have been established using calibrated physical measurements and reference systems designed to simulate and quantify motion, rather than expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set

The document does not provide information on the training set or its sample size. This is a 510(k) submission for a medical device accessory, not a detailed AI/ML model submission that typically requires such information. The device uses "structured light technique" and "geometric alignment" for motion tracking, implying a more traditional signal processing or computer vision approach rather than a complex trainable deep learning model in the typical sense that would have a large, specific training set.

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

As no training set details are provided, no information is available on how ground truth for a training set was established.

Summary

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August 29, 2022

TracInnovations A/S % Stefan Glimberg CTO Brydehusvej 13 Ballerup, 2750 DENMARK

Re: K221785

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: June 13, 2022 Received: June 21, 2022

Dear Stefan Glimberg:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221785

Device Name

TCL3 Motion Tracking 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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K221785 510(k) Summary Prepared August 26, 2022

Sponsor:	TracInnovationsBrydehusvej 13 DK-2750Ballerup Denmark
Contact Person:	Stefan GlimbergCTOsg@tracinnovations.com
Telephone:	+45 93 88 11 65
Submission Date:	August 26, 2022
Device Name:	TCL3 Motion Tracking System
Common Name:	Magnetic Resonance Diagnostic Device (MRDD)
Trade Name:	TCL3 Motion Tracking System
Classification:	Regulatory Class: IIReview Category: 21CFR 892.1000 (LNH)Classification Panel: Radiology

A. Legally Marketed Predicate Devices

The predicate device is the TCL3 Motion Tracking System Motion Correction System (K203451) manufactured by TracInnovations.

B. Device Description:

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C. Intended Use / Indications for Use

D. Substantial Equivalence

The TracInnovations Motion Tracking System is substantially equivalent to the TracInnovations Motion Tracking System (K203451).

Device Name	Predicate DeviceTracInnovations MotionTracking System (K203451)	Subject DeviceTracInnovations MotionTracking System	SE
Indications forUse	The TCL3 Motion TrackingSystem is an accessory to aMagnetic Resonance Imaging(MRI) scanner. The systemuses a markerless sensor basedtechnology for tracking ofpatient movement during anMRI session. It provides thecurrent position of the patientin real-time to the MRIscanner.The TCL3 System is intendedto support, supplement and/oraugment the performance ofthe Siemens Magnetom Skyra,Siemens Magnetom Prisma,Philips Achieva and GE SignaPremier scanners.	The TCL3 Motion TrackingSystem is an accessory to aMagnetic Resonance Imaging(MRI) scanner. The systemuses a markerless sensor basedtechnology for tracking ofpatient movement during anMRI session. It provides thecurrent position of the patient inreal-time to the MRI scanner.The TCL3 Motion TrackingSystem is intended tosupport, supplement, and/oraugment the performance ofMRI scanners that have beenvalidated for compatibility.	Yes
Intended Users	Professional UseEnvironment: Hospital,doctor's office, or any facilitythat uses an MRI device.	Professional Use Environment:Hospital, doctor's office, or anyfacility that uses an MRIdevice.	Identical
Review Panel	Radiology	Radiology	Identical
Product code	LNH	LNH	Identical
Regulationnumber	892.1000	892.1000	Identical
Regulation	Magnetic resonance diagnosticdevice	Magnetic resonance diagnosticdevice	Identical
Classification	II	II	Identical
	Predicate DeviceTracInnovations MotionTracking System(K203451)	Subject DeviceTracInnovations MotionTracking System	SubstantiallyEquivalent
Core Technology	TracInnovations defines itsTCL3 Motion TrackingSystem as an accessory to amedical device. It is intendedto support, supplement and/oraugment the performance ofthe scanners indicated below.	TracInnovations defines itsTCL3 Motion Tracking Systemas an accessory to a medicaldevice. It is intended to support,supplement and/or augment theperformance of scanners.	Identical
Marker required	No. Attachment of amarker is not required	No. Attachment of a markeris not required	Identical
Data acquisitionsensor	Use one camera and oneinfrared light modulator(projection of structuredlight patterns) to identifyand track a surface.	Use one camera and oneinfrared light modulator(projection of structured lightpatterns) to identify and tracka surface.	Identical
Line of sight	Line of sight for thecamera and infrared lightmodulator to the patient	Line of sight for the cameraand infrared light modulatorto the patient	Identical
MRI scannercompatibility	Siemens MAGNETOMPrisma 3TSiemens MAGNETOMSkyra 3TSiemens Biograph mMR3TPhilips Achieva 3T	Scanners that have beenvalidated for compatibility	SubstantiallyEquivalent
Scanner borecompatibility	60 cm and 70 cm boresystems	60 cm and 70 cm boresystems	Identical
Scanner mounting	Attachment on the scannertable, Detachable	Attachment on the scannertable, Detachable	Identical
Communicationwith scanners	Ethernet connection,UDP/IP protocol	Ethernet connection, UDP/IPprotocol	Identical
Powering	Battery, >8 hours	Battery, >8 hours	Identical
Motion tracking	Tracks motion of the headin 6 degrees of freedom(x,y,z translations, androtations)	Tracks motion of the head in6 degrees of freedom (x,y,ztranslations, and rotations)	Identical
Translationalaccuracy	200 μm	200 μm	Identical
Rotational accuracy	0.2 degrees	0.2 degrees	Identical
Recording rate	30 frames per second	30 frames per second	Identical
Cross calibrationprocedure	Iteratively adapting	Iteratively adapting	Identical

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 indications for use and technological characteristics, the subject device is substantially equivalent to the TracInnovations original 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 TracInnovations 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. The verification and validation testing included testing to the following applicable standards:

ISO 14971	Application of risk management to medical devices
IEC 60601-1	Medical electrical equipment- General requirements forbasic safety and essential performance
IEC 60601-1-2	Electromagnetic disturbances
IEC 62304	Medical device software - Software life-cycleprocesses
EN IEC 62471; 2006	Photobiological safety of lamps and lamp systems –Part 2 Guidance on manufacturing requirementsrelating to Non-Laser Optical Radiation Safety

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:

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
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.
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 not result in any new issues of safety or efficacy.

Therefore, the TracInnovations Motion Tracking System is substantially equivalent to the original TracInnovations predicate device (K203451) with regards to intended use and technological characteristics. Results of performance testing demonstrated that the design requirements and as well as the user needs.

Regulation Number and Section

N/A