BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTracelO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.

During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.

BioTracelO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.

BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.

Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.

The physician should not rely on BioTraceIO Precisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.

Device Description

BioTracelO Precision is a stand-alone software application with tools and features designed to assist users in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

BioTracelO Precision is a software application that uses a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.

The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm. providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).

AI/ML Overview

Acceptance Criteria and Study for BioTraceIO Precision (2.0)

The BioTraceIO Precision (2.0) device is a software application designed to assist physicians in assessing the ablation zone created by liver tissue ablation procedures. The key functionality is to generate a "BioTrace Map" (BTM) that correlates with the ablation zone visualized on Contrast-enhanced Computed Tomography (CECT) obtained 24 hours post-treatment.

Here's a breakdown of the acceptance criteria and the study that proves the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Target Performance	Reported Device Performance (BioTraceIO Precision 2.0)
Mean DICE coefficient vs. 24-hour CECT (BTM)	Equivalent to predicate device	84.7 [95% CI: 83.07, 86.49] vs. 85.5 [95% CI: 83.63, 87.43] for predicate (p=0.2408; Wilcoxon p=0.11)
Mean DICE coefficient vs. 24-hour CECT (Optimized BTM vs. T=0 CECT)	Significantly higher than T=0 CECT	7.9 [95% CI: 4.2, 11.7) higher (p < 0.0001; Wilcoxon p < 0.0001)
BTM algorithm processing time	Optimized to reduce delay (display within 15 mins)	Achieves display within 15 minutes post-procedure
RAZ algorithm implementation	Same as BTM processing for optimization/maintenance	Adapted to have the same implementation as BTM
User Interface (UI) modifications	Improved user experience	Implemented (e.g., button layout improvements, selection of reference US frame for needle marking)
Cybersecurity	Improved security	Implemented (e.g., encryption of PHI, installation responsibilities)
Technical modifications	Implemented	Name change, file configuration change, architecture change

Note: The primary acceptance criterion for the algorithmic performance was demonstrating equivalent performance of the optimized BTM algorithm to the predicate BTM algorithm when correlated with 24-hour CECT. The improved performance against T=0 CECT was a favorable additional finding.

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

Test Set Sample Size: The document does not explicitly state the exact number of cases or patients in the test set. However, it implicitly indicates that the test set included sufficient data to conduct statistical analyses (paired t-test, Wilcoxon Signed-Rank test) and generate 95% Confidence Intervals (CIs) for DICE coefficients, comparing the new algorithm with the predicate and T=0 CECT. This suggests a reasonably sized dataset.
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin). The document states the data was used for "algorithmic testing," implying it was collected from actual patient procedures. The data collected was retrospectively analyzed for this validation.

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

Number of Experts: Not explicitly stated in the provided text.
Qualifications of Experts: Not explicitly stated. The ground truth ("ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT)") is itself an objective imaging finding. While interpretation of CECT images is done by radiologists, the document doesn't detail the role or number of human experts for ground truth establishment outside of "ablation zone visualized on the 24-hour post ablation CECT." It focuses more on the correlation between the device's output and this objective imaging finding.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly mentioned for the establishment of the 24-hour CECT ground truth. The ground truth is described as the "ablation zone visualized on the 24-hour post ablation CECT." It implies that this CECT visualization is the accepted reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, the provided text does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The study focuses purely on the equivalence of the device's algorithmic performance (BioTraceIO Precision 2.0 BTM) against a predefined ground truth (24-hour CECT) when compared to a predicate device. The device provides "adjunctive information" and is "not intended for standalone prediction or for diagnostic purposes," which aligns with the absence of an MRMC study assessing human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, the algorithmic testing described is a standalone performance evaluation of the BioTraceIO Precision (2.0) BTM algorithm. The DICE coefficient was calculated by comparing the algorithm's output directly to the 24-hour CECT images, without a human in the loop for the performance measurement itself.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used was imaging data, specifically the "ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT)." This is considered a clinical reference standard for assessing the success and extent of liver ablation.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not provide the sample size for the training set. The focus of this 510(k) summary is on the validation of the updated device (BioTraceIO Precision 2.0) against its predicate, rather than the initial development and training specifics.

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

Ground Truth for Training Set: Not explicitly stated in the provided text. For a device like BioTraceIO Precision, it is highly likely that similar to the testing phase, the training set ground truth would have also been established using 24-hour CECT imaging to precisely delineate the ablation zones, potentially with expert radiologist annotations or consensus. However, the document does not elaborate on this.

Summary

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Image /page/0/Picture/0 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 USA 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.

December 27, 2024

TechsoMed Medical Technologies Ltd. Dalia Dickman Head of Regulatory Affairs Meir Weisgal 2 REHOVOT, 7654055 ISRAEL

Re: K243084

Trade/Device Name: BioTraceIO Precision (2.0) Regulation Number: 21 CFR 892.2052 Regulation Name: Post-Ablation Tissue Response Prediction Software Regulatory Class: Class II Product Code: QZL Dated: December 2, 2024 Received: December 2, 2024

Dear Dalia Dickman:

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.

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).

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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 (QS) 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 Rue"). 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.

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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, Digitally signed by Shahram for Shahram Vaezy -S Vaezy -S Date: 2024.12.27 13:58:03 -05'00'

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team 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) K243084

Device Name BioTraceIO Precision (2.0)

Indications for Use (Describe)

During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.

BioTracelO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.

BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.

Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.

The physician should not rely on BioTraceIO Precisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

K243084

TechsoMed's BioTracelO Precision

Submitter

TechsoMed Medical Technologies. LTD. Meir Weisgal 2 Rehovot Israel

Phone: +972545595951

Contact Person: Dalia Dickman, PhD.

Date Prepared: September 26, 2024

Name of Device: BioTraceIO Precision (2.0)

Common or Usual Name: BioTracelO Precision

Classification Name: Post-Ablation Tissue Response Prediction Software (CFR 892.2052)

Regulatory Class: Class II

Product Code: QZL

Predicate Device

510(k) Number	DEN230020
Trade Name	BioTraceIO Precision
Manufacturer	TechsoMed Medical Technologies. LTD.
Device Name	BioTraceIO Lite
Regulation Number	892.2052
Regulation Name	Post-Ablation Tissue Response Prediction Software
Regulatory Class	Class II
Primary Product Code	QZL

Reference Device

510(k) Number	K240773
Trade Name	BioTraceIO Vision
Manufacturer	TechsoMed Medical Technologies. LTD.
Device Name	VisAble.IO
Regulation Number	892.2050
Regulation Name	Medical Image Management and Processing System
Regulatory Class	Class II
Product Code	QTZ, QIH, LLZ

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Device Description

visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).

Intended Use / Indications for Use

BioTracelO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

BioTraceIO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Centrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.

During the ablation procedure BioTracelO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.

BioTracelO Precision is not intended for standalone prediction or for diagnostic purposes. BioTracelO Precision does not support the use of multiple needles, either simultaneously or consecutively.

Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.

The physician should not rely on BioTraceIO Precision BTM alone in decisions about patient management post treatment nor should BioTracelO Precision serve as a substitute for any other assessment method, e.g., CT scans.

Summary of Technological Characteristics

Both the subject and predicate device are stand-alone software applications that use a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.

The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm, providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace

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Map (BTM), after the completion of the procedure (Offline Mode).

The following technological differences exist between the subject and the predicate device:

The primary differences between devices are: (1) BTM algorithm processing time has been optimized to reduce delay for the user, and in turn is displayed in the offline mode 15 minutes after the ablation procedure has been completed (2) the RAZ algorithm has been adapted to have the same implementation used for BTM processing for the purpose of algorithm optimization and easier maintenance (3) user interface (UI) modifications have been made to improve the user experience

(4) cybersecurity improvements have been made (5) technical modifications have been made such as name change, file configuration change and architecture change.

A table comparing the key features of the subject and predicate devices is provided below.

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Substantial Equivalence Comparison Table

	Subject Device	Predicate Device
	BioTraceIO Precision (Ver 2.0)	BioTraceIO Precision(previously commercially namedBioTraceIO Lite)
DeNovo/510(k)number	K243084	DEN230020
Classification	Class II QZL	Class II QZL
Intended Use	A stand-alone software applicationwith tools and features designed toassist users in their clinicalassessment of ablation zonecreated by liver tissue ablation, aspart of their overall post-procedureclinical assessment.	A stand-alone software applicationwith tools and features designed toassist users in their clinicalassessment of ablation zonecreated by liver tissue ablation, aspart of their overall post-procedureclinical assessment.
IndicationsforUse	BioTraceIO Precision is intendedto provide physicians withadjunctive information in theirclinicalassessment of ablation zonecreated by liver tissue ablation, aspart of their overall post-procedureclinical assessment.BioTraceIO Precision generatesand depicts a map (BioTrace Mapor BTM) post-procedure, thatcorrelates with image findingsseen with Contrast-enhancedComputed Tomography (CECT)obtained at 24 hours posttreatment. The information isprovided in the 2D ultrasoundplane. This is the only planeand location displayed. No imagingof other portions of the ablationzone is available.During the ablation procedureBioTraceIO Precision overlays thereference ablation zone (RAZ)provided by the ablation devicemanufacturer on the ultrasoundimage.BioTraceIO Precision is indicatedfor use in patients undergoingradiofrequency (RF) or microwave(MW) liver ablation procedures.BioTraceIO Precision is notintended for standalone predictionor for diagnostic purposes.BioTraceIO Precision does notsupport the use of multiple	BioTraceIO Lite is intended toprovide physicians with adjunctiveinformation in their clinicalassessment of ablation zonecreated by liver tissue ablation, aspart of their overall post-procedureclinical assessment.BioTraceIO Lite generates anddepicts a map (BioTrace Map orBTM) post-procedure, thatcorrelates with image findings seen withContrast-enhanced ComputedTomography (CECT) obtained at 24hours post treatment. Theinformation is provided in the 2Dultrasound plane. This is the onlyplaneand location displayed. No imagingof other portions of the ablationzone is available.During the ablation procedureBioTraceIO Lite overlays thereference ablation zone (RAZ)providedby the ablation device manufactureron the ultrasound image.BioTraceIO Lite is indicated for usein patients undergoingradiofrequency (RF) or microwave(MW)liver ablation procedures.BioTraceIO Lite is not intended forstandalone prediction or fordiagnostic purposes.
	needles, either simultaneously orconsecutively.Manual ablation target contoursand margins as defined by the userare not intended for diagnosis, topredict ablation volumes or predictablation success.The physician should not rely onBioTraceIO Precision BTM alonein decisions about patientmanagementpost treatment nor shouldBioTraceIO Precision serve as asubstitute for any otherassessment method,e.g., CT scans.	BioTraceIO Lite does not supportthe use of multiple needles, eithersimultaneously or consecutively.The physician should not rely onBioTraceIO Lite BTM alone indecisions about patientmanagementpost treatment nor shouldBioTraceIO Lite serve as asubstitute for any other assessmentmethod,e.g., CT scans.
PrimaryDifferences	(1) the BTM algorithm processingtime has been optimized throughenhancements in algorithmarchitecture to reduce delay for theuser, and in turn is displayed in theoffline mode 15 minutes after theablation procedure has beencompleted (2) the RAZ algorithmhas been updated to utilize thesame architectural framework asthe BTM algorithm. This adaptationfacilitates optimization andsimplifies maintenance (3) userinterface (UI) modifications havebeen made to improve the userexperience such as button layoutimprovements and allow forselection of a reference US framefor needle marking (4)cybersecurity improvements havebeen made such as encryption ofPHI and installation responsibilities(5) technical modifications havebeen made such as name change,report viewer file configurationchange and software frameworkarchitecture change.	NA
User Population	Qualified trained operators	Qualified trained operators
Where used	BioTraceIO Precision isdesignated for use in a clinicaloperating environment withcompatible ultrasound and livertissue ablation devices.	BioTraceIO Precision is designatedfor use in a clinical operatingenvironment withcompatibleultrasound and liver tissue ablationdevices.
Energy Used	None - software only application.The software application does notdeliver or depend on energydelivered to or from patients	None - software only application.The software application does notdeliver or depend on energydelivered to or from patients
TechnologicalCharacteristics	BioTraceIO Precision is a softwareapplication that uses a proprietarycomputational algorithm to analyzeultrasound images captured during	BioTraceIO Precision is a softwareapplication that uses a proprietarycomputational algorithm to analyzeultrasound images captured during
	liver ablation treatment(microwave ablation [MWA] orradiofrequency ablation [RFA]), as depicted instandard abdominal ultrasoundimaging.The streamed ultrasound imagesare captured and analyzed by theBioTraceIO algorithm, providing avisual display of the expectedablation zone, namely theReference Ablation Zone (RAZ),calculated based on technicalparameters provided by theablation manufacturer datasheet.The RAZ is displayed, during theprocedure (Online Mode).BioTracelO Precision alsoprovides a visual display of theestimated ablation zone correlativeto the 24-hour CECT, namely theBioTrace Map (BTM)fifteen (15) minutes after thecompletion of the procedure(Offline Mode).Color-coded display of scoresreflecting image quality andreliability of the RAZ motioncompensation displayed in the UIusing a color-coded 5-point scale.These scores are computed basedon objective metrics, and theirpurpose is to ensure the correctexecution of the algorithms in theBioTraceIO Precision system.Manual contouring of ablationtarget on the reference US frameand display of the ablation marginas defined by the user around thecontour. This feature was cleared inK240773.	liver ablation treatment (microwaveablation [MWA] or radiofrequencyablation [RFA]), as depicted instandard abdominal ultrasoundimaging.The streamed ultrasound imagesare captured and analyzed by theBioTraceIO algorithm, providing avisual display of the expectedablation zone, namely theReference Ablation Zone (RAZ),calculated based on technicalparameters provided by the ablationmanufacturer datasheet. The RAZis displayed, during the procedure(Online Mode). BioTracelOPrecision also provides a visualdisplay of the estimated ablationzone correlative to the 24-hourCECT, namely the BioTrace Map(BTM), thirty (30) minutes after thecompletion of the procedure (OfflineMode).Generation of scores reflecting imagequality and reliability of the RAZmotion compensation which runs asbackground calculations within thesoftware and is not visible to the user.These scores are computed basedon objective metrics, and theirpurpose is to ensure the correctexecution of the algorithms in theBioTraceIO Precision system.NA
Design:DataVisualization	BTM on offline mode; RAZ ononline mode	BTM on offline mode; RAZ ononline mode
Design;DataInput	Used with a hardware streamingdevice that is connected to anultrasound machine output, tocapture input ultrasound images.	Used with a hardware streamingdevice that is connected to anultrasound machine output, tocapture input ultrasound images.
Design:OnlineMode	In online mode, the BioTracelOalgorithm analyses the ultrasoundimages, and calculates atransformation matrix per frame.The transformation matrix definesthe movement and orientationchange between two frames and isused to transform the RAZ andregister it to the ultrasound image.	In online mode, the BioTracelOalgorithm analyses the ultrasoundimages, and calculates atransformation matrix per frame.The transformation matrix definesthe movement and orientationchange between two frames and isused to transform the RAZ andregister it to the ultrasound image.
	In offline mode, the BioTraceIOalgorithm calculates the BTM as itis generated during the procedure.	In offline mode, the BioTraceIOalgorithm calculates the BTM as it isgenerated during the procedure.
	BTM calculations are based on thebiological response of the tissue toheating and its appearance onultrasound imaging.	BTM calculations are based on thebiological response of the tissue toheating and its appearance onultrasound imaging.
Design:	In offline mode, the BioTraceIOalgorithm calculates the BTM as itis generated during the procedure.	In offline mode, the BioTraceIOalgorithm calculates the BTM as it isgenerated during the procedure.
Mode	BTM calculations are based on thebiological response of the tissue toheating and its appearance onultrasound imaging.	BTM calculations are based on thebiological response of the tissue toheating and its appearance onultrasound imaging.
Offline

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Performance Data

BioTraceIO Precision is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission.

The results of functional and algorithmic testing demonstrate that BioTracelO Precision meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.

Alqorithmic testing was performed on the BTM alqorithm, to ensure that performance and accuracy was as expected. The validation analysis resulted in a mean DICE coefficient of 84.7 [95% C1: 83.07, 86.49] and 85.5 [95% Cl: 83.63, 87.43] for the optimized BTM and predicate BTM, respectively, as compared to ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT). This result was tested using both paired t-test (p = 0.2408), as well as Wilcoxon Signed-Rank test (p = 0.11). Both methodologies yielded similar non-significant p-values, indicating no

significant differences in measurement of mean dice coefficients between the two algorithms. The optimized BTM also demonstrated a significantly (paired t-test p < 0.0001; Wilcoxon Signed-Rank p < 0.0001) higher mean DICE coefficient compared to T=0 CECT when both were compared to T=24 CECT, with a mean within-tumor difference of 7.9 [95% CJ: 4.2, 11.7) in favor of the optimized BTM.

These results correspond to the intended use of the device in correlating with the ablation zone visualization on T=24 CECT and supports its clinical utility.

The mean DICE coefficient for BioTracelO Precision BTM compared to T=24 CECT was not significantly lower than the mean DICE coefficient for BioTracelO Lite BTM versus T=24 CECT. This result highlights that BioTracelO Precision BTM demonstrates equivalent performance in correlation of ablation zone visualized on T=24 CECT compared to the predicate BTM.

Overall, the validation has successfully demonstrated that the optimized BTM demonstrates equivalent performance to the predicate BTM, and that it is safe and effective in estimating the area of ablation zone as visualized at 24-hour post procedure CECT scan.

Test planning was performed in accordance with standard testing procedures and quidelines as listed in internal development processes.

Verification and validation testing were carried out as per planned arrangements in the Project Test Plan and Phase Test Plan(s) to ensure that design outputs meet design inputs and that this version

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of BioTracelO Precision meets the product acceptance criteria. These are in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices" and adherence to the DICOM standard.

Conclusions

The BioTracelO Precision (V2.0) is as safe and effective as the cleared BioTracelO Precision (DEN230020). The BioTracelO Precision has the same intended use, and principles of operation and similar technological characteristics as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the BioTracelO Precision and its predicate device raise no new issues of safety or effectiveness. Algorithmic testing demonstrates that the BioTraceIO Precision (V 2.0) is as safe and effective as the cleared BioTracelO Precision (DEN230020). Thus, the BioTraceIO Precision is substantially equivalent to the predicate device.

Regulation Number and Section

N/A