TRAQinform IQ

K233998 · Aiq Global, Inc. · LLZ · Sep 5, 2024 · Radiology

Device Facts

• Record ID: K233998
• Device Name: TRAQinform IQ
• Applicant: Aiq Global, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

TRAQinform IQ is a software only device that provides a quantitative TRAQinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use. Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for local image interpretation do not interact with the device and generate their reporting before and independently of the TRAQinform Report. The TRAQinform Report is generated by the device manufacturer and signed by a U.S. board certified physician responsible for supervising central report generation and qualified to practice nuclear radiology/medicine. The TRAQinform Report is for use by trained medical professionals including but not limited to oncologists, nuclear radiologists/physicians, medical imaging technologists, dosimetrists, and physicists.

Device Story

Software-only device; operates in secure cloud environment. Inputs: DICOM 3.0 CT and PET/CT images. Processing: Machine learning-based skeletal/anatomic segmentation; threshold-based ROI identification/contouring; automated ROI registration/matching across timepoints/modalities. Outputs: Quantitative report detailing ROI volume, tracer uptake (SUV), and radio density (HU) changes; 2D/3D graphical renderings. Used by oncologists, radiologists, and physicists as an adjunct to local image interpretation. Device manufacturer generates reports, signed by board-certified physician. Benefits: Provides standardized quantitative metrics to assist clinicians in evaluating lesion changes over time; supports multidisciplinary review of progression status.

Clinical Evidence

Bench testing included software V&V and component-level feasibility. Clinical evidence included a test-retest study (n=31) to establish limits of agreement for SUV and volume metrics. A pivotal reader study (n=103) evaluated clinical utility by comparing oncologist progression classification with and without the device report. Results showed the device prompted reevaluation of 32 patients; panel agreement with device classification for highlighted ROIs ranged from 63% to 90% depending on the change category.

Technological Characteristics

Software-only; cloud-hosted. Modalities: DICOM 3.0 CT and PET/CT. Segmentation: Machine learning-based skeletal/anatomic. ROI identification: Threshold-based. Connectivity: Cloud-based with web browser interface. Outputs: Quantitative metrics (SUV, HU, volume) and 3D/2D renderings.

Indications for Use

Indicated for adult patients 22 years and older undergoing partial or whole-body PET/CT imaging. Multi-timepoint analysis: FDG PET/CT scans with second administration within 12 months of first. Single-timepoint analysis: FDG, PSMA-targeted, or SSTR-targeted PET/CT scans. Not for binary patient-level progression decisions without multidisciplinary review. Not for diagnosis, treatment recommendation, or replacement of professional judgment.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• QTxI (K173444)

Reference Devices

• MIM 4.1 (SEASTAR) (K071964)

Submission Summary (Full Text)

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December 5, 2024

AIQ Global, Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103

Re: K233998

Trade/Device Name: TRAQinform IQ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ

Dear Kelliann Payne:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 5, 2024. Specifically, FDA is updating this SE Letter to address a typo in the IFU form as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Daniel Krainak, OHT8: Office of Radiological Health, 301-796-0478, [e-mail].

Sincerely.

D. R. K.

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

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September 5, 2024

AIQ Global, Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103

Re: K233998

Trade/Device Name: TRAQinform IQ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 18, 2023 Received: December 18, 2023

Dear Kelliann Payne:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D. G. K.

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) K233998

Device Name

TRAQinform IQ

#### Indications for Use (Describe)

TRAQinform IQ is a software only device that provides a quantitative TRAOinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use.

Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for local image interpretation do not interact with the device and generate their reporting before and independently of the TRAQinform Report.

The TRAQinform Report is generated by the device manufacturer and signed by a U.S. board certified physician responsible for supervising central report generation and qualified to practice nuclear radiology/medicine. The TRAQinform Report is for use by trained medical professionals including but not limited to oncologists, nuclear radiologists/physicians, medical imaging technologists, dosimetrists, and physicists.

TRAQinform IQ software contains the following functionalities:

- · Automated matching of ROI between previously performed CT and PET/CT DICOM 3.0 volumetric medical images.
- · In order to perform automated matching of ROI and quantitative analysis of previously performed CT and PET/CT DICOM 3.0 volumetric medical images, the software initially performs the following functions:
- · Machine learning skeletal and anatomic structure segmentation.
- · Threshold-based ROI identification and contouring.
- · Automated quantitative analysis to assess previously performed CT and PET/CT DICOM 3.0 volumetric medical images, including: change in total volume and dentified ROI, and change in Fludeoxygluose F18 (FDG) tracer uptake of each identified ROI among images.
- · Generation of images of the anatomy combined with spatial and quantitative information, including computed classification of quantitative FDG ROI changes.

For multi-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or wholebody PET/CT acquired following administration of FDG per approved drug prescribing information and with the second FDG administration separated from the first by a period not to exceed 12 months.

For single-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or wholebody PET/CT following administration of FDG, a PSMA targeted PET drug, or a SSTR-targeted PET drug per approved drug prescribing information.

Discrepancies between TRAQinform IQ and local PET/CT reporting have been investigated and use of TRAQinform IQ has not been established for binary patient level progression decisions without multidisciplinary review. Discrepancies between TRAQinform IQ and local PET/CT reporting that could impact patient care should therefore prompt consultation with subject matter experts (for example, with a patient-centered focus on discrepant imaging regions and with blinded or otherwise neutral adjudication regarding interpretation/classification source.

TRAQinform IQ is not intended to diagnose any disease. replace the diagnostic procedures for interpretation of CT or PET/CT images, recommend any specific treatment, nor is it intended to replace the skill and judgment of a qualified medical professional.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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## K233998

#### 510(k) SUMMARY AIQ Global, Inc's TRAQinform IQ

#### Submitter

AIQ Global, Inc. (dba AIQ Solutions) 8000 Excelsior Dr. Suite 400 Madison, WI 53717 [phone]

#### Contact Person

Alberti Dona, COO [phone] [e-mail]

#### Date Prepared

Auqust 28, 2024

#### Device Identification

Proprietary Name: TRAQinform IQ Common Name: System, Image Processing, Radiological Regulation No: 21 CFR 892.2050 Picture Archiving and Communications System Product Code: LLZ Regulatory Class: Class II Classification Panel: Radiology

#### Predicate Device

Name of Device: QTxI 510(k) Number: K173444 Regulation No: 21 CFR 892.2050 Product Code: LLZ Regulatory Class: Class II Classification Panel: Radiology

#### Reference Device

Name of Device: MIM 4.1 (SEASTAR) 510(k) Number: K071964 Regulation No: 21 CFR 892.2050 Product Code: LLZ Regulatory Class: Class II Classification Panel: Radiology

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### Device Description and Technological Characteristics

TRAQinform IQ is a software only device that provides quantitative analysis of lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use.

The input to TRAQinform IQ is CT and PET/CT images as supported by ACR/NEMA DICOM 3.0.

The following steps are performed by the software:

- . Automatic threshold-based ROI segmentation:
- ROI can also be imported from external sources (other validated tools or manual contouring о by qualified medical personnel).
- Automatic ROI registration between multiple images:
- Images can be from the same or different imaging modality. O
- Images can be from the same or different PET tracer. O
- Images can be from the same or different date. O
- Automatic matching of ROI between multiple, previously performed images. ●
- Automatic quantification of dynamic changes among images including, but not limited to: ●
- Changes in ROI shape. o
- Single ROI splitting into multiple ROI. O
- Multiple ROI combining into a single ROI. O
- ROI appearing, disappearing, and re-appearing across images. O
- A comprehensive summary analysis. ●

TRAQinform IQ calculates spatial and quantitative metrics for each individual ROI. These metrics are provided as a TRAQinform Report. TRAQinform IQ uses computational algorithms to detect, fuse and analyze ROI and provides the following outputs:

- . Identification of anatomic location of ROI in all areas of the body.
- . A quantitative analysis of functional and anatomic data for CT and PET/CT scans, including:
- Volume of all identified ROI on each image; O
- Change in volume of each identified ROI among images: O
- Total volume of all identified ROI on each image; O
- Change in total volume of all identified ROI on each image; O
- Heterogeneity of change in volume of each identified ROI: o
- For PET scans: O
- Tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of each identified ROI on . each image:
- . Change in tracer uptake (SUVmax, SUVtotal, SUVmean) of each identified ROI among images:
- . Total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image:
- I Change in total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image:
- . Heterogeneity of change in tracer uptake (SUVhetero) among identified ROI.
- For CT scans O
- Radio density (HUmax, HUtotal, HUmean, HUhetero) for each identified ROI on each '

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image:

- Changes in radio density (HUmax. HUtotal. HUmean) of all identified ROI on each image:
- . Change in total radio density (HUmax, HUtotal, HUmean, HUhetero) of all identified ROI on each image;
- 트 Heterogeneity of change in radio density (HUhetero) among identified ROI.
- . 2D graphical renderings of medical images, including Maximum Intensity Projections of the PET and CT, with overlayed and labeled/color-coded ROI, for inclusion in TRAQinform Reports.
- . 3D labeled contours for ROI, anatomic structures, and skeletal structures.

The TRAQinform IQ software operates in a secure cloud environment.

### Intended Use / Indications for Use

.

TRAQinform IQ is a software only device that provides a quantitative TRAQinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use.

Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for local image interpretation do not interact with the device and generate their reporting before and independently of the TRAQinform Report.

The TRAQinform Report is generated by the device manufacturer and signed by a U.S. board certified physician responsible for supervising central report generation and qualified to practice nuclear radiology/medicine. The TRAQinform Report is for use by trained medical professionals including but not limited to oncologists, nuclear radiologists/physicians, medical imaging technologists, dosimetrists, and physicists.

TRAQinform IQ software contains the following functionalities:

- Automated matching of ROI between previously performed CT and PET/CT DICOM 3.0 . volumetric medical images.
- . In order to perform automated matching of ROI and quantitative analysis of previously performed CT and PET/CT DICOM 3.0 volumetric medical images, the software initially performs the following functions:
- Machine learning skeletal and anatomic structure segmentation.
- Threshold-based ROI identification and contouring.
- . Automated quantitative analysis to assess previously performed CT and PET/CT DICOM 3.0 volumetric medical images, including: change in total volume and density of each identified ROI, and change in Fludeoxyglucose F18 (FDG) tracer uptake of each identified ROI among images.
- . Generation of images of the anatomy combined with spatial and quantitative information. including computed classification of quantitative FDG ROI changes.

For multi-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT acquired following administration of FDG per approved drug prescribing information and with the second FDG administration separated from the first by a period not to exceed 12 months.

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For single-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT following administration of FDG, a PSMA targeted PET drug, or a SSTR-targeted PET drug per approved drug prescribing information.

Discrepancies between TRAQinform IQ and local PET/CT reporting have been investigated and use of TRAQinform IQ has not been established for binary patient level progression or non-progression decisions without multidisciplinary review. Discrepancies between TRAQinform IQ and local PET/CT reporting that could impact patient care should therefore prompt consultation with subject matter experts (for example, in tumor board), with a patientcentered focus on discrepant imaging regions and with blinded or otherwise neutral adjudication regarding interpretation/classification source.

TRAQinform IQ is not intended to diagnose any disease, replace the diagnostic procedures for interpretation of CT or PET/CT images, recommend any specific treatment, nor is it intended to replace the skill and judgment of a qualified medical professional.

### Performance Testing

Results of software validation and verification (V&V) and early feasibility testing of device component functionality for CT segmentation, regional PET thresholding, and ROI matching supported further FDG test-retest and pivotal device output investigation. For detail on component testing, published reporting is available respectively in Weisman 2023 (CT anatomy segmentation, doi.org/10.1088/2057-1976/acfb06), Perk 2018 (ROI detection methodology, doi.org/10.1088/1361-6560/aaebba), and Huff 2023 (ROI matching, doi.org/10.1088/1361-6560/acef8f).

### Test-Retest

This study established test-retest limits of agreement used to categorize regions of interest based off changes between FDG PET/CT images. 31 patients with non-small lung cancer patients received two FDG PET/CT images within 1 week pretreatment. The limits of repeatability endpoint estimated the interval within which 95% of repeated measurements are expected to lie when clinically relevant change is lacking. For TRAQinform IQ generated features, these limits are shown in Table 1.

| Feature | Lower limit (%) | Upper limit (%) |
|----------|-----------------|-----------------|
| SUVmax | -27.0 | 56.8 |
| SUVmean | -20.2 | 38.5 |
| SUVtotal | -54.1 | 144.5 |
| Volume | -52.6 | 113.9 |

Table 1: Lower and upper limits of repeatability for each imaging feature.

### Pivotal Reader Study

A study was conducted to evaluate the clinical utility of TRAQinform IQ. In this study, three report evaluators (oncologists) were assigned to distinguish each of 103 patients as positive versus

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neqative for progression based on presentation of the locally generated radiology report without and then with adjunctive presentation of the TRAQinform Report.

Each of the 103 patients had two sequential FDG PET/CT scans acquired between 2005 and 2022. Scans were acquired from patients scanned at 10 or more imaging centers in at least 3 U.S. states (exact image center information was redacted on scan transfer). A full breakdown is shown in Table 2. A breakdown of patients by disease type, patient sex, weight, and age are also shown in Table 2. Out of the 206 total scans (2 per patient), scanner information was available for 199 (99 patients). Scans were acquired on a variety of scanner manufacturers and models, with 84 patients receiving scans on the same scanner for baseline and follow-up.

A total of 1046 ROI were detected across the baseline scans (median per patient: 6, range: 0-80) and 935 were detected on the follow-up (median per patient: 4, range: 0-60).

#### Table 2: Patient and scan characteristics for all patients and scans where information was not redacted during the scan transfer process.

| Imaging Site /<br>Location | Site 1 (North Carolina, USA), n = 35<br>Site 2 (Unknown State, USA) , n = 31 Site 3<br>(North Carolina, USA), n = 13<br>Site 4 (North Carolina, USA), n = 12<br>Site 5 (Iowa, USA), n = 4<br>Site 6 (North Carolina, USA), n = 3<br>Site 7 (North Carolina, USA), n = 2<br>Site 8 (Unknown State, USA), n = 1<br>Site 9 (North Carolina, USA), n = 1<br>Site 10 (Missouri, USA), n = 1 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cancer Type, n | Breast Cancer, n = 23<br>Lung Cancer, n = 20<br>Prostate, n = 16<br>Melanoma, n = 15<br>Head & Neck Cancer, n = 8<br>Lymphoma, n = 7<br>Colorectal Cancer, n = 6<br>Other, n = 5<br>Gynecological Cancer, n = 3 |
| Patient sex, n<br>Female / Male | 57/46 |
| Patient age, years<br>Median (range) | 66 (26, 87) |
| Patient weight, kg<br>Median (range) | 78.5 (43.0, 132.9) |
| Patient Race | Unreported, n = 75<br>White, n = 25<br>Hispanic, n = 2<br>Black, n = 1 |

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| Scanner model<br>(n=199) | Siemens Healthineers Biograph 20, n = 76<br>Siemens Healthineers BioGraph TruePoint, n = 46<br>Canon Medical Systems Celesteion, n = 41<br>Canon Medical Systems Cartesion Prime, n = 14<br>GE Healthcare Discovery ST, n = 12<br>Siemens Healthineers Biograph6, n = 7<br>Siemens Healthineers Biograph Horizon, n = 3 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Of the 103 patients investigated, the TRAQInform Report prompted at least one oncologist interpreter to reevaluate 23 patients classified without the device as negative for progression to positive, and to reevaluate 9 patients classified without the device as positive for progression to negative. In these cases, the oncologist interpreter highlighted a subset of ROI for further review. Imaging and local reporting on these 23 + 9 = 32 patients was sent to a panel of two radiologists and one oncologist, together serving as a reference source against which to quantify positive percent agreement (PPA, representing patients classified as positive by both the panel and an oncologist), negative percent agreement (NPA; representing patients classified as negative by both the panel and an oncologist), and the 95% confidence interval (95%Cl) for overall percent agreement (OPA; prevalence-biased PPA and NPA aggregation). Compared to chance performance (50%), the 95% CI for OPA was 41% to 76%. PPA was 14/18=78% and NPA was 5/14=36%.

Because reevaluation at the patient level was derived from reporting at a lower ROI level, panel agreement was also evaluated at this level. The panel examined only the subset of ROI that had been highlighted by the report evaluators. Of 111 total ROIs highlighted on the TRAQInform Report, the panel agreed with the device classification (new, increasing, unchanged, decreasing, and disappearing) in 37/53=70%, 18/26=70%, 11/13=85%, 5/8 (63%), and 10/11 (90%) ROIs, respectively.

### Comparison of Technological Characteristics to Predicate

TRAQinform IQ is a modification of the predicate device. Both the subject and predicate devices are intended to be used by trained medical professionals as an aid in evaluation and information management of digital medical images. Specifically, both devices are radiological image processing systems intended to assess patient radiological scans to provide supplemental information to physicians on changes to regions of interest (ROI).

Comparison of key technological features are provided in Table 3.

### Conclusion

The TRAQinform IQ has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device. Differences do not alter the intended use of the device and do not raise different questions of safety and effectiveness when used as labeled. The performance data demonstrate that the TRAQinform IQ is as safe and effective as the QTxl. Thus, the TRAQinform IQ is substantially equivalent.

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# Table 3: Substantial Equivalence Table

| Specification /<br>Characteristic | TRAQinform IQ<br>Subject Device | Quantitative Total Extensible<br>Imaging (QTxl) (K173444)<br>Predicate Device |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ |
| Regulation<br>Number | 892.2050 | 892.2050 |
| Regulatory Class | II | II |
| Review Panel | Radiology | Radiology |
| Users | Trained medical professionals including, but<br>not limited to, radiologists, oncologists,<br>nuclear medicine physicians, medical imaging<br>technologists, dosimetrists and physicists. | Trained medical professionals<br>including, but not limited to,<br>radiologists, oncologists, nuclear<br>medicine physicians, medical imaging<br>technologists, dosimetrists and<br>physicists. |
| Intended Use | A software tool to aid in evaluation and<br>information management of digital medical<br>images. | A software tool to aid in evaluation<br>and information management of digita<br>medical<br>images. |
| Indications for<br>Use | TRAQinform IQ is a software only device that<br>provides quantitative analysis of lesions<br>identified as Regions of Interest (ROI) in<br>PET/CT DICOM compliant imaging data<br>acquired, interpreted, and reported on per local<br>practice prior to device use.<br>Clinicians responsible for patient care and for<br>ordering TRAQinform Reports as an adjunct to<br>locally reported image interpretation do not<br>interact directly with the device. Clinicians<br>responsible for local image interpretation do<br>not interact with the device and generate their<br>reporting before and independently of the<br>TRAQinform Report.<br>The TRAQinform Report is generated by the<br>device manufacturer and signed by a U.S.<br>board certified physician responsible for<br>supervising central report generation and<br>qualified to practice nuclear<br>radiology/medicine. The TRAQinform Report is<br>for use by trained medical professionals<br>including but not limited to oncologists, nuclear | Quantitative Total Extensible Imaging<br>(QTxl) is a software tool used to aid in<br>evaluation and information management<br>of digital medical images by trained<br>medical professionals including, but not<br>limited to, radiologists, oncologists,<br>nuclear medicine physicians, medical<br>imaging technologists, dosimetrists and<br>physicists. The medical modalities of<br>these medical images include, but are<br>not limited to, DICOM CT and PET as<br>supported by ACR/NEMA DICOM 3.0. |
| Specification /<br>Characteristic | TRAQinform IQ<br>Subject Device | Quantitative Total Extensible Imaging<br>(QTxI) (K173444)<br>Predicate Device |
| | TRAQinform IQ software contains the<br>following functionalities:<br>Automated matching of ROI between<br>previously performed CT and PET/CT<br>DICOM 3.0 volumetric medical<br>images. In order to perform automated<br>matching of ROI and quantitative<br>analysis of previously performed CT<br>and PET/CT DICOM 3.0 volumetric<br>medical images, the software initially<br>performs the following functions: Machine learning skeletal and<br>anatomic structure<br>segmentation. Threshold-based ROI<br>identification and contouring. Automated quantitative analysis to<br>assess previously performed CT and<br>PET/CT DICOM 3.0 volumetric<br>medical images, including: change in<br>total volume and density of each<br>identified ROI, and change in<br>Fludeoxyglucose F18 (FDG) tracer<br>uptake of each identified ROI among<br>images. Generation of images of the anatomy<br>combined with spatial and quantitative<br>information, including computed<br>classification of quantitative FDG ROI<br>changes. | QTxI assists in the following indications:<br>Receive, store, retrieve, display<br>and process digital medical<br>images Create, display and print reports<br>from those images Provide medical professionals<br>with the ability to display,<br>register, and fuse medical<br>images Identify Regions of Interest (ROIs)<br>and perform ROI contouring<br>allowing quantitative/statistical<br>analysis of full or partial body scans Evaluate quantitative change in<br>ROIs (total or partial body;<br>individual ROI within individual) with<br>3D interactive rendering of images<br>with highlighted ROIs. |
| Specification /<br>Characteristic | TRAQinform IQ<br>Subject Device | Quantitative Total Extensible Imaging<br>(QTxI) (K173444)<br>Predicate Device |
| | For multi-timepoint quantitative analysis,<br>recommended use is in adult patients 22<br>years and older with partial or whole-body<br>PET/CT acquired following administration<br>of FDG per approved drug prescribing<br>information and with the second FDG<br>administration separated from the first by<br>a period not to exceed 12 months. | |
| | For single-timepoint quantitative analysis,<br>recommended use is in adult patients 22<br>years and older with partial or whole-body<br>PET/CT following administration of FDG,<br>a PSMA targeted PET drug, or a SSTR-<br>targeted PET drug per approved drug<br>prescribing information. | |
| | Discrepancies between TRAQinform IQ<br>and local PET/CT reporting have been<br>investigated and use of TRAQinform IQ<br>has not been established for binary<br>patient level progression or non-<br>progression decisions without<br>multidisciplinary review. Discrepancies<br>between TRAQinform IQ and local<br>PET/CT reporting that could impact<br>patient care should therefore prompt<br>consultation with subject matter experts<br>(for example, in tumor board), with a<br>patient-centered focus on discrepant<br>imaging regions and with blinded or<br>otherwise neutral adjudication regarding<br>interpretation/classification source. | |
| | TRAQinform IQ is not intended to<br>diagnose any disease, replace the<br>diagnostic procedures for interpretation of<br>CT or PET/CT images, recommend any<br>specific treatment, nor is it intended to<br>replace the skill and judgement of a<br>qualified medical professional. | |
| Specification /<br>Characteristic | TRAQinform IQ<br>Subject Device | Quantitative Total Extensible Imaging<br>(QTxI) (K173444)<br>Predicate Device |
| Medical Modalities | CT and PET/CT images as supported by<br>ACR/NEMA DICOM 3.0 | DICOM, CT, MRI, SPECT and PET as<br>supported by ACR/NEMA DICOM 3.0 |
| Medical Modalities | Radiotracers for multiple timepoints: FDG | Radiotracers: NaF PET |
| Medical Modalities | Radiotracers for single timepoint: FDG,<br>PSMA-targeted PET drug, or a SSTR-<br>targeted PET drug | |
| Operating System | Secure Cloud Environment with Web<br>Browser Interface | Windows 7 or Windows 10 |
| Identification of<br>ROI | Automatic Threshold based ROI<br>identification in bone and anatomical<br>structures | Threshold based ROI identification in bone |
| Importation of<br>ROI contours | TRAQinform IQ allows the importation of<br>physician established contours of ROI | No importation functionality |
| Segmentation | Segmentation of bone to identify skeletal<br>structures and segmentation of<br>anatomical structures to identify organs.<br>Segmentation is driven by machine<br>learning algorithms. | Atlas based segmentation of bone to identify<br>skeletal structures |
| Quantitative<br>Analysis | Scan-to-scan registration and ROI<br>matching allows automatic<br>quantification of ROIs and assessment<br>of changes/differences in ROI:<br>Changes in ROI shapeSingle ROI splitting into multiple ROIMultiple ROI combining into a single ROIROI appearing, disappearing, and re- appearing across images<br>Quantitative analysis of functional and<br>anatomical data for CT and PET/CT<br>scans, including:<br>Volume of each identified ROI on each image | Scan-to-scan registration and ROI matching<br>allows automatic quantification of ROIs and<br>assessment of changes/differences in ROI.<br>Quantitative/statistical analysis of full or<br>partial-body scans |
| | Change in volume of each identified ROI among imagesTotal volume of all identified ROI on each image | |
| Specification /<br>Characteristic | TRAQinform IQ<br>Subject Device | Quantitative Total Extensible Imaging<br>(QTxI) (K173444)<br>Predicate Device |
| | Change in total volume of all identified ROI on each image Heterogeneity of change in volume of each identified ROI For PET scans: Tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of each identified ROI on each image Change in tracer uptake (SUVmax, SUVtotal, SUVmean) of each identified ROI among images Total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image Change in total tracer uptake (SUVmax, SUVtotal, SUVmean, SUVhetero) of all identified ROI on each image Heterogeneity of change in tracer uptake (SUVhetero) among identified ROI For CT scans: Radio density (HUmax, HUtotal, HUmean, HUhetero) for each identified ROI on each image Changes in radio density (HUmax, HUtotal, HUmean) of all identified ROI on each image Change in total radio density (HUmax, HUtotal, HUmean, HUhetero) of all identified ROI on each image Heterogeneity of change in radio density (HUhe…