TrackX is a software application which captures diagnostic images from a fluoroscope via a video cable. In addition, TrackX interfaces with an off-the-shelf tracking system in order to track the position of surgical instruments relative to the fluoroscope. The user controls and views information via a primary monitor. The viewing monitor is not part of the subject device.

TrackX will track the location of the tip of a surgical instrument. TrackX works by translating and rotating an X-ray image which contains the surgical instrument on the screen based on the surgeon's movement of the instrument. This real-time feedback allows the physician to reposition the instrument with greater accuracy between X-ray images. This aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images.

AI/ML Overview

The provided FDA 510(k) summary for TrackX v.2.0 (K200360) describes the device's acceptance criteria and the study that proves the device meets them.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Instrument Tracking with Optical	Instrument Tracking with Optical
The location of projected markers should be within a 2mm mean of their expected 10mm increment from the detected instrument tip to each consecutive projected marker.	"The testing demonstrated that TrackX met specifications." (This implies the 2mm mean deviation criterion was met, but the exact quantitative result is not provided in this summary.)
Software Verification	Software Verification
Implement the intended changes for both the projection feature and the home base selector.	"The software testing performed for the modifications that are the subject of this Special 510(k) used established test methods that were used for the predicate device." (This confirms the new features were implemented and tested as intended.)

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

The provided document does not specify the sample size used for the bench testing of "Instrument Tracking with Optical" or the software verification testing. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective) for these tests. The testing described is "bench testing," which typically refers to lab-based, simulated scenarios rather than patient data.

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)

The document does not mention the use of experts to establish a ground truth for the test set. The "Instrument Tracking with Optical" testing appears to rely on a predefined, expected 10mm increment for projected markers, suggesting a technical ground truth rather than expert interpretation.

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

No adjudication method is mentioned in the provided summary. The testing described is bench testing against predefined technical specifications.

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

No MRMC comparative effectiveness study was performed or needed as indicated by the statement: "Clinical Study: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This device is a software application that assists with fluoroscopic procedures by tracking instruments and providing visual cues, not an AI-driven diagnostic reader.

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

Yes, the performance data presented (Bench Testing, Software Verification and Validation) represents standalone testing of the algorithm/software's functionality and accuracy against predefined specifications, without human-in-the-loop performance evaluation in a clinical setting.

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

For the "Instrument Tracking with Optical" bench testing, the ground truth was based on expected technical measurements (e.g., the "expected 10mm increment" between projected markers). For the "Software Verification," the ground truth was the intended functionality and changes for the new features (Projection and Home Base Selector).

8. The sample size for the training set

The document does not provide any information about a training set. This is because TrackX v.2.0 is described as a software application that captures images and interfaces with a tracking system to translate and rotate images and track instrument location. It does not appear to be an AI/machine learning device that requires a training set in the conventional sense for image classification or prediction. The changes are "new features, Projection and Home Base Selector," which are functionally implemented, not learned.

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

As no training set is mentioned or implied for this type of device and its new features, information on how its ground truth was established is not applicable.

Summary

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Image /page/0/Picture/10 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Track X Technology, LLC % Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 ALEXANDRIA VA 22314

March 5, 2020

Re: K200360

Trade/Device Name: TrackX v.2.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, LLZ, JAA Dated: February 12, 2020 Received: February 13, 2020

Dear Calley Herzog:

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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Indications for Use

510(k) Number (if known) K200360

Device Name TrackX v.2.0

Indications for Use (Describe)

TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.

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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K200360 - 510(K) SUMMARY

1. SUBMITTER

Submitter:	TrackX Technology, LLC200 Timberhill Place, Suite 223Chapel Hill, NC 27514Tel: 888-787-2259
Contact Person:	David SkwererTel: 888-787-2259david.skwerer@trackx.tech
Submission Correspondent:	Calley HerzogSenior ConsultantBiologics Consulting Group, Inc.1555 King St., Suite 300Alexandria, VA 22314(720) 883-3633cherzog@biologicsconsulting.com
Date Prepared:	March 4, 2020

DEVICE 2.

Name of Device:	TrackX v.2.0
Common or Usual Name:	Image processing system
Regulation Name:	Image-intensified fluoroscopic x-ray system21 CFR § 892.1650
Regulatory Class:	Class II
Classification Product Code:	OWB
Subsequent Product Codes:	LLZ, JAA

PREDICATE DEVICE 3.

Predicate Device Name:	TrackX
Manufacturer:	Track X Technology, LLC

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510(k) Number:	K173736
Regulation Name:	Image-intensified fluoroscopic x-ray system21 CFR § 892.1650
Regulatory Class:	Class II
Classification Product Code:Subsequent Product Codes:	OWBLLZ, JAA
Reference Devices:	No reference devices were used in this submission.

DEVICE DESCRIPTION 4.

TrackX is designed per recommendations provided in the following FDA guidance documents:

. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Off-The-Shelf Software Use in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices
Design Considerations and Pre-market Submission Recommendations for ● Interoperable Medical Devices

INDICATION FOR USE న్.

The indications for use statement is identical to that of the predicate device:

TrackX is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6. WITH THE PREDICATE DEVICE

The predicate device is the submitter's own Track X as cleared in K173736. The purpose of this 510(k) is to acquire clearance of two new features, Projection and Home Base Selector.

The markers used with the TrackX software are identical to the snaps used with the predicate device with additional snaps noted in letters to file.

	Proposed Device	Predicate Device
510(k) Number	K200360	K173736
Submitter	TrackX Technology, LLC	TrackX Technology, LLC
Classification Regulation	892.1650 - Image-intensifiedfluoroscopic X-ray system	892.1650 - Image-intensifiedfluoroscopic X-ray system
Classification Product Code	OWB - interventionalfluoroscopic X-ray system	OWB - interventionalfluoroscopic X-ray system
Subsequent Product Codes	JAA - system, X-ray,fluoroscopic, image-intensifiedLLZ - system, image processing,radiological	JAA - system, X-ray,fluoroscopic, image-intensifiedLLZ - system, image processing,radiological
Device Class	2	2
Indications	Indicated for use in anyapplication where a fluoroscopeis incorporated to aid in diagnosisand treatment of disease.	Indicated for use in anyapplication where a fluoroscopeis incorporated to aid in diagnosisand treatment of disease.
Compatible HardwarePlatforms	Any computer that meets thefollowing minimumspecifications:CPU: Intel i5GPU: NVIDIA 760RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339, Elgato or AccustreamOperating System: Windows 10	Any computer that meets thefollowing minimumspecifications:CPU: Intel i5GPU: NVIDIA 760RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339 or ElgatoOperating System: Windows 10
Software is run on a stand-alone computer and monitor	Yes	Yes
Device is passive and doesn'tcontrol the fluoroscope	Yes	Yes
For use during procedures thatinvolve fluoroscopy	Yes	Yes
	Proposed Device	Predicate Device
Provides visual cues which helpguide the user in positioningthe instrument back to where itwas when a prior X-ray imageof it was taken.	Yes	Yes
Requires a tracking systemwhen tracking is being used.	Yes	Yes
Requires a tracker to interfacewith the tracking system.	Yes	Yes
Requires a sterile trackerattached to the instrument inorder to track the location ofthe tip of the surgicalinstrument.	Yes	Yes
Allows the user to select whichtracked object is the originrelative to which the C-armand Instruments are tracked.(Home Base Selector)	Yes	No
Provides a measurement off ofa reference point in the X-rayimage. (Projection)	Yes	No

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The modifications described above do not change the fundamental technology or the intended use of the device. Therefore, based on the identical indications, similar technological characteristics, and results of performance testing, TrackX is substantially equivalent to the submitter's own cleared device K173736.

7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Like the predicate device, there are no direct or indirect patient-contacting components of the subject device. Therefore, biocompatibility testing is not needed for this device.

Sterilization

Like the predicate device, the only sterile components are the TrackX Snaps that are attached to the instrument. TrackX Snaps are provided sterile, for single use only, and labeled with a threeyear shelf life. The snaps are sterilized using Gamma sterilization, and the sterilization method has been validated in accordance with AAMI/ISO 11137-1 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices (2006) to demonstrate a Sterility Assurance Level (SAL) of 10 °.

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Shelf Life

Accelerated aging tests were conducted to support a three-year shelf life on samples having been packaged and sterilized to a single (validated) sterilization cycle. The validated cycle includes a minimum of 25 kGy and a maximum of 40 kGy exposure and is the same process used to sterilize the final device.

Electrical Safety and electromagnetic compatibility (EMC)

Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Bench Testing

Instrument Tracking with Optical

The purpose of this testing was to verify that TrackX with the Polaris optical tracking system is able to provide a measurement off a reference point in the X-ray image. The location of projected markers should be within a 2mm mean of their expected 10mm increment from the detected instrument tip to each consecutive projected marker. The testing demonstrated that TrackX met specifications. The testing used established test methods that were used for the predicate device.

Software Verification

The purpose of this testing is to implement the intended changes for both the projection feature and the home base selector. The software testing performed for the modifications that are the subject of this Special 510(k) used established test methods that were used for the predicate device.

Animal Study

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Study

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSIONS 8.

As described above, based on the Indication for Use identical to the predicate device, similar technological characteristics, and results of performance testing, TrackX v. 2.0 is substantially equivalent to the TrackX as cleared in K173736.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.