(267 days)
Not Found.
Not Found.
Unknown
The document mentions a "computational algorithm" and "image processing software" but does not explicitly state that AI or ML is used. The performance metrics (Dice coefficient, sensitivity, PPV) are consistent with image analysis, but don't definitively indicate AI/ML. There is no mention of training or test sets in the context of model development, which would be expected for an AI/ML device.
No.
The device provides adjunctive information for clinical assessment but does not directly treat or diagnose a condition.
No
The "Intended Use / Indications for Use" section explicitly states "BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes."
Yes
The device is described as a "software application" that uses a "computational algorithm" to analyze images. It is installed on an "off-the-shelf, computer workstation" and connects to existing ultrasound systems for input, but does not control or change the functions of the ultrasound or ablation devices. This indicates it is a software-only device running on general-purpose hardware.
Based on the provided information, BioTraceIO Lite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- BioTraceIO Lite's Function: BioTraceIO Lite analyzes imaging data (ultrasound and correlates with CECT) obtained during and after a medical procedure (liver ablation). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it provides "adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation." This is based on image analysis, not laboratory testing of biological samples.
- Device Description: The description details software analysis of ultrasound images and correlation with CECT findings. There is no mention of handling or analyzing biological specimens.
Therefore, BioTraceIO Lite falls under the category of a medical device that processes and analyzes medical images to provide clinical information, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BioTraceIO Lite 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 Lite 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 24 hours 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 Lite overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Lite is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures. BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Lite does not support the use of multiple needles, either simultaneously or consecutively. The physician should not rely on BioTraceIO Lite BTM alone in decisions about patient management post treatment nor should BioTraceIO Lite serve as a substitute for any other assessment method, e.g., CT scans.
Product codes
QZL
Device Description
BioTraceIO Lite is a software application that uses a 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 BioTraceIO algorithm, providing a visual display of the expected ablation zone (calculated based on technical parameters provided by the ablation manufacturer datasheet), namely the Reference Ablation Zone (RAZ), during the procedure (Online Mode - Figure 1).
Thirty (30) minutes after the completion of the procedure, BioTraceIO Lite provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM) (Offline Mode - Figure 2).
Once in Offline Mode, it is not possible to return to Online Mode. The BTM is displayed only in Offline Mode, 30 minutes after the ablation procedure has been completed, and cannot be visualized in Online Mode, during the procedure.
Information from the ultrasound system streams in only one direction, to the BioTracelO Lite software. BioTraceIO Lite utilized in either Online or Offline mode does not control or change the functions or parameters of the ultrasound system, or the ablation device used during the liver ablation procedure.
The BioTraceIO Lite application is installed on a dedicated, off-the-shelf, computer workstation with pre-defined minimal requirements and is controlled by the user via an independent user interface, which is separate from both the ablation system and the ultrasound system. The workstation is connected by video output to a compatible ultrasound system to be used during the liver tumor ablation procedure. Specifications for compatible ultrasound systems are defined in Table 1:
| Specification | General Parameter |
|---|---|
| Transducer type | Curved |
| Frequency | 3-5 MHz |
| Gain | Maximal |
| Scan Line Density | High |
| Image Size/Screen Resolution | 800×600, 960×720, |
| 1024×768, 1920×1080 | |
| CNR | X > 3 dB |
| Dynamic Range | 60-70 dB |
| Maximum Depth of Field | 20 cm |
| Minimum Depth of Field | 2 cm |
Mentions image processing
Yes, "Post-ablation tissue response prediction software is an image processing software device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Liver tissue
Indicated Patient Age Range
Mean age of patients in the study was 66.0 years, with a range of 46.0 to 81.0 years.
Intended User / Care Setting
Physicians in a clinical assessment setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
The evaluable subjects for the primary effectiveness endpoint were 50 patients with 51 ablations. The imaging data acquired in the study (T=0 and T=24 CECT) was analyzed independently by certified interventional radiology experts, blinded to each other. These experts were trained on the CECT segmentation and registration processes specific to this study. The primary endpoint evaluation used a paired comparison of the Dice similarity coefficient, assessed between BTM and T=24 CECT, and between T=0 CECT and T=24 CECT.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Trial - Pivotal study. A multi-center prospective single-arm pivotal clinical study.
Sample Size: 50 evaluable subjects with 51 ablations for effectiveness analysis. 59 patients for safety analysis.
Key Results:
Primary Effectiveness Endpoints: The mean Dice coefficient for BTM compared to T=24 CECT was 85.5 (SD 6.8), which was significantly higher than the mean Dice coefficient for T=0 CECT versus T=24 CECT (76.8, SD 12.7). The p-value for the paired T-Test was
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR BIOTRACEIO LITE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Post-ablation tissue response prediction software. Post-ablation tissue response prediction software is an image processing software device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.
NEW REGULATION NUMBER: 21 CFR 892.2052
CLASSIFICATION: Class II
PRODUCT CODE: QZL
BACKGROUND
DEVICE NAME: BioTraceIO Lite
SUBMISSION NUMBER: DEN230020
DATE DE NOVO RECEIVED: March 30, 2023
SPONSOR INFORMATION:
TechsoMed Medical Technologies, Ltd. 2 Meir Weisgal St. Rehovot 7632605 Israel
INDICATIONS FOR USE
The BioTraceIO Lite is indicated as follows:
BioTraceIO Lite 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 Lite 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 24 hours 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.
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During the ablation procedure BioTraceIO Lite overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Lite is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures. BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Lite does not support the use of multiple needles, either simultaneously or consecutively. The physician should not rely on BioTraceIO Lite BTM alone in decisions about patient management post treatment nor should BioTraceIO Lite serve as a substitute for any other assessment method, e.g., CT scans.
LIMITATIONS
- . The sale, distribution, and use of the BioTraceIO Lite are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
BioTraceIO Lite is a software application that uses a 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 BioTraceIO algorithm, providing a visual display of the expected ablation zone (calculated based on technical parameters provided by the ablation manufacturer datasheet), namely the Reference Ablation Zone (RAZ), during the procedure (Online Mode - Figure 1).
Image /page/1/Figure/6 description: The image shows a list of device inputs by the end-user, including ablation vendor, needle model, ablation duration, ablation power, and needle trajectory marking. There are also images showing needle trajectory marking and a continuous display of RAZ on an ultrasound image. The needle trajectory marking is shown in yellow. The RAZ is displayed on the ultrasound image.
Figure I. Schematic of BioTraceIO Lite, as used in Online Mode
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Thirty (30) minutes after the completion of the procedure, BioTraceIO Lite provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM) (Offline Mode - Figure 2).
Image /page/2/Figure/1 description: The image shows a diagram of the BioTrace Map (BTM) process. The first step is device input, which involves ultrasound recordings from the procedure. The second step is analysis, which involves the BioTracelO algorithm analysis of ultrasound recordings to generate BTM. The final step is the BioTrace Map (BTM).
Figure 2. Schematic of BioTraceIQ Lite, as used in Offline Mode. Overlay of BTM (red) on processed ultrasound image
Once in Offline Mode, it is not possible to return to Online Mode. The BTM is displayed only in Offline Mode, 30 minutes after the ablation procedure has been completed, and cannot be visualized in Online Mode, during the procedure.
Information from the ultrasound system streams in only one direction, to the BioTracelO Lite software. BioTraceIO Lite utilized in either Online or Offline mode does not control or change the functions or parameters of the ultrasound system, or the ablation device used during the liver ablation procedure.
The BioTraceIO Lite application is installed on a dedicated, off-the-shelf, computer workstation with pre-defined minimal requirements and is controlled by the user via an independent user interface, which is separate from both the ablation system and the ultrasound system. The workstation is connected by video output to a compatible ultrasound system to be used during the liver tumor ablation procedure. Specifications for compatible ultrasound systems are defined in Table 1:
| Specification | General Parameter |
|---|---|
| Transducer type | Curved |
| Frequency | 3-5 MHz |
| Gain | Maximal |
Table 1: Specifications for Compatible Ultrasound System
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| Scan Line Density | High |
|---|---|
| Image Size/Screen Resolution | 800×600, 960×720, |
| 1024×768, 1920×1080 | |
| CNR | $ X > 3 dB$ |
| Dynamic Range | 60-70 dB |
| Maximum Depth of Field | 20 cm |
| Minimum Depth of Field | 2 cm |
Mechanism of Action
During ablation. in the presence of elevated temperatures, denatured tissues emit dissolved nitrogen, and microbubbles form. Once the gas microbubbles (also referred to as "bubbles") start to form within the heat-induced tissue, their continued formation and removal by the blood stream creates a unique traceable dynamic. The static and dynamic behavior of the gas microbubbles over time affects the spatial echogenicity of the ultrasound image throughout the ablation procedure. The BioTraceIO Lite algorithm performs automatic detection of dynamic gas bubble activity on each ultrasound frame in a single 2-D slice.
SUMMARY OF NONCLINICAL/BENCH STUDIES
Bench testing was conducted to demonstrate that BioTraceIO Lite performs as expected under the anticipated conditions of use. The following bench testing was conducted to demonstrate the device performance characteristics:
SOFTWARE AND CYBERSECURITY
The BioTraceIO Lite software documentation and testing provided demonstrate that the device meets all requirements outlined in the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for software of moderate level of concern and Cybersecurity outlined in Section 524B of Federal Food, Drug, and Cosmetic Act (FD&C Act).
PERFORMANCE TESTING - ANIMAL
A preclinical study was conducted to evaluate the technical performance of the BioTraceIO algorithm during in-vivo percutaneous porcine liver microwave ablation procedure and to compare the BTM with the ablation zone visualized on the 24-hour post ablation CECT.
One pig was subjected to transcutaneous microwave ablation ((b)(4) Microwave Ablation System) using (6)(4) performed at the same power with varying ablation durations for each of the ablation cases and was monitored using a BK Flex Focus 800 ultrasound system. Twenty-four (24) hours following the ablation procedure, the pig was subjected to CECT and was euthanized immediately after the imaging procedure. The results of this study showed a
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mean ratio of 93% (± 4.39 SD) between the BTM and the ablation zone visualized on the 24-hour post ablation CECT.
SUMMARY OF CLINICAL INFORMATION
Clinical Trial- Pivotal study
A multi-center prospective single-arm pivotal clinical study was performed to demonstrate the safety and effectiveness of BioTraceIO Lite for assessment of tissue ablation and predicting the ablated area following RF and Microwave liver tissue ablation procedures. The study was conducted at six clinical sites in the United States.
The overall objective of this study was to demonstrate the safety and effectiveness of BioTraceIO Lite by estimating whether the BTM, depicted immediately post ablation procedure in RF and Microwave liver ablation procedures, correlates to the ablation zone as visualized in 24-hour post-procedure (T=24) CECT scan. The current standard of care (SoC) is use of a CECT immediately following the ablation (T=0) only, with post-treatment and follow-up decisions based on the appearance of the ablated region immediately post-ablation. However, the ablation zone continues to change as time progress, therefore the T=0 CECT offers incomplete visualization of the size of the final ablation zone.
Primary effectiveness objective:
The primary effectiveness objective was to demonstrate that the BTM available postprocedure is correlative to the area of ablation zone as visualized on 24-hours postprocedure (T=24) CECT scan.
Primary safety objective:
The primary safety objective of this study was to demonstrate that the BioTracelO Lite device is safe, based on an assessment of device-related Adverse Events (AEs) and serious adverse events (SAEs).
Study Endpoints
Primary Endpoints
-
. Effectiveness
To demonstrate that the BTM available 30 minutes post-procedure is correlative to the area of ablation zone as visualized in 24-hour post-procedure (T=24) CECT scan. -
Safety .
Incidence and severity of device-related adverse events occurring from the beginning of the liver ablation procedure until the completion of the T=24 CECT.
Secondary Endpoints:
- Sensitivity and Precision of the BTM at T=0 compared to CECT at T=24. .
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-
. Directional Expansion Distance as detected by the BTM, in the same direction as the ablation zone visualized on 24-hour CECT maximal expansion distance.
Exploratory Endpoints: -
Comparison between ablation volume visualized at T=0 CECT the ablation volume . visualized at T=24 CECT.
-
. The proportion of patients in whom the investigator indicated that, if the BTM was available for use in patient management, it would have impacted their follow-up plan for patient management, compared to the T=0 CECT alone (the standard of care).
Study Design
The primary endpoint was evaluated using a paired comparison of the Dice similarity coefficient. assessed between BTM, as measured at the end of the ablation procedure (from the oblique ultrasound plane that was monitored during the procedure), and the ablation zone based on 24 hours post-procedure CECT (T=24) (from the 2D CECT plane corresponding to the ultrasound oblique plane), and the Dice similarity coefficient, assessed between the ablation zone based on immediate post-procedure CECT (T=0) (from the 2D CECT plane corresponding to the ultrasound oblique plane) and the ablation zone based on 24 hours post-procedure CECT (T=24). For each patient and each pair of compared methods (i.e.: BTM vs T=24 CECT and T=0 vs. T=24 CECT) the area of ablation zone was overlaid.
The analysis of the imaging data acquired in the study (i.e., T=0 and T=24 CECT) was performed independently by certified interventional radiology experts, blinded to each other. The experts were trained on the CECT segmentation and registration processes specific to this study. During the study, the physicians were provided with questionnaires regarding RAZ and BTM benefits.
Image /page/5/Figure/7 description: The image shows a diagram with the labels FN, IN, FP, and TP. The text "CECT at T 24 lu Reference method" and "Bio Trace at 1-0 CLC1 at 1-041est method" are also present. The diagram appears to be a visual representation of some kind of classification or testing method.
Figure 3. Analysis method for comparing ablation zones.
Based on the overlay of areas, as shown in Figure 3, the following values were defined:
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-
- True Positive (TP) was calculated based the number of pixels that overlap between T=24 CECT (blue area) and T=0 CECT (grey area).
-
- False Negative (FN) was calculated based on the number of pixels that appear in the ablation zone visualized on T=24 CECT (blue area), but not in the ablation zone visualized on the T=0 CECT (grev area).
-
- False Positive (FP) was calculated based on the number of pixels that do not appear either in the ablation zone visualized on T=24 CECT, nor that of the T=0 CECT.
2 × TP Dice = = = = = = = = = = = TP Dice similarity coefficient was calculated using:
TP Sensitivity was calculated using:
TP Positive Predictive Value (PPV; Precision) was calculated using: PPV = =================================================================================================
The analysis of the imaging data acquired in the study (i.e., T=0 and T=24 CECT) was performed independently by certified interventional radiology experts, blinded to each other. The experts were trained on the CECT segmentation and registration processes specific to this study. During the study, the physicians were provided with questionaries regarding RAZ and BTM benefits.
Directional Expansion Distance
BTM directional expansion distance was estimated in the direction of the maximal distance obtained between T=0 CECT and T=24 CECT contours. This distance is denoted as "True Expansion". The True Expansion was considered as the highest risk area (worst case scenario), where the recognizable ablation zone is the furthest from the contour of the T=0 CECT. Similarly, the distance between BTM and T=24 CECT contour was calculated in the direction of True Expansion, and the difference between this distance and the True Expansion was calculated.
The BioTrace Map max expansion can provide either complete match, over estimation or partial match as compared to the maximal difference seen between the ablation zone contour in T=0 CECT and that of T=24 CECT (True Expansion). In addition, the BioTrace map could show under estimation as compared to the ablation zone contour seen on T=0 CECT.
Sample size
Study flow chart below represents the number of subjects in the study. The study was powered to include 50 evaluable subjects. Subjects were considered evaluable for the primary effectiveness endpoint if they have completed ablation procedure, T=0 CECT, BTM calculation and T=24hrs CECT. If one of these elements is missing, the subject was deemed not evaluable. The results were calculated for 50 patients with 51 ablations.
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Image /page/7/Figure/0 description: This image shows a flowchart of a study. The study begins with 64 screened and signed ICF, with 4 screen failures. The study ends with 53 completed study per-protocol. There are several reasons for participants dropping out of the study, including loss to follow-up, device deficiency, and withdrawal.
Figure 4. Study Flow Chart.
CECT at 24 hours post-procedure was not performed for 5 ablations in 5 patients. Of them, 3 patients with a total of 3 ablations terminated the study prior to post-procedure CT for different reasons. For the other 2 patients, within-procedure major protocol deviations occurred. Specifically, for 1 patient an unapproved ultrasound probe was used during the procedure; therefore, the patient was defined as ineligible and was not invited for the T=24 CECT. For another patient, an additional ablation was performed after repositioning of the needle which made this subject ineligible and the T=24 CECT was not performed. In addition, 2 patients with 3 ablations underwent T=24 CECT, but the results did not allow estimation of the ablation zone due to overlapping ablation zones, or bleeding. Thus, valid effectiveness results were calculated for 50 patients with 51 ablations.
Table 2-6 includes information on demographic characteristics, gender and race distribution, and liver and tumor characteristics of the study samples.
Descriptive statistics of patient age, height, weight, and BMI are presented in Table 2.
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| Parameter | Mean | Std | Min | Median | Max | N |
|---|---|---|---|---|---|---|
| Age (years) | 66.0 | 9.0 | 46.0 | 68.0 | 81.0 | 50 |
| Height (cm) | 171.0 | 35.0 | 140.0 | 173.0 | 188.0 | 50 |
| Weight (kg) | 88.6 | 27.9 | 46.2 | 88.0 | 141.8 | 50 |
| BMI (kg/m2) | 30.2 | 6.9 | 16.2 | 29.3 | 52.5 | 50 |
Table 2. Descriptive Statistics of Demographic Characteristics
Patient gender and race are presented in Table 3.
Table 3. Frequency Distribution of Gender and Race
| Characteristic / Result | N | % | 95% CI | |
|---|---|---|---|---|
| Gender | Male | 39 | 78.0 | 64.0 - 88.5 |
| Female | 11 | 22.0 | 11.5 - 36.0 | |
| Other | 0 | 0.0 | 0.0-7.1 | |
| Unknown | 0 | 0.0 | 0.0-7.1 | |
| All | 50 | 100.0 | ||
| Race | American Indian or Alaska Native | 0 | 0.0 | 0.0-7.1 |
| Asian | 0 | 0.0 | 0.0-7.1 | |
| Black or African American | 2 | 4.0 | 0.5 - 13.7 | |
| Native Hawaiian or Other Pacific Islander | 0 | 0.0 | 0.0-7.1 | |
| White or Caucasian | 44 | 88.0 | 75.7 - 95.5 | |
| Unknown or Not Reported | 4 | 8.0 | 2.2 - 19.2 | |
| All | 50 | 100.0 |
Liver and Tumor Characteristics
The number of patients with different liver and tumor conditions is summarized in Table .
Table 4. Summary of Patient Liver and Tumor Characteristics
| Characteristic / Result | N | % | 95% CI | |
|---|---|---|---|---|
| Liver Condition | Healthy | 11 | 22.0 | 11.5–36.0 |
| Fibrotic | 2 | 4.0 | 0.5–13.7 | |
| Cirrhotic | 30 | 60.0 | 45.2–73.6 | |
| Fatty | 5 | 10.0 | 3.3–21.8 |
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| Characteristic / Result | N | % | 95% CI | |
|---|---|---|---|---|
| Other | 2 | 4.0 | 0.5 - 13.7 | |
| All | 50 | 100.0 | ||
| Type of Liver Tumor | NT* | % | ||
| Primary | 33 | 64.7 | 50.1 - 77.6 | |
| Metastatic | 18 | 35.3 | 22.4 - 49.9 | |
| All | 51 | 100.0 |
Tumor location (liver segment) is specified in Table 5.
Table 5. Frequency Distribution of Liver Tumor Location (live segment)
| Tumor Location
| (liver segment) | NT* | % | 95% CI |
|---|---|---|---|
| 2 | 7 | 13.7 | 5.7 - 26.3 |
| 3 | 3 | 5.88 | 1.2 - 16.2 |
| 4a/b | 2 | 3.9 | 0.4 - 13.5 |
| 5 | 11 | 21.6 | 11.3 - 35.3 |
| 6 | 8 | 15.7 | 7.0 - 28.6 |
| 7 | 12 | 23.5 | 12.8-37.5 |
| 8 | 8 | 15.7 | 7.0 - 28.6 |
| All | 51 | 100.0 |
- Nf refers to the number of tumors / ablations
Tumor diagonal is described in Table 6.
Table 6. Descriptive Statistics of Liver Tumor Diagonal
Tumor Diagonal (mm)
| Mean | Std | Min | Median | Max | NT |
|---|---|---|---|---|---|
| 18.0 | 6.38 | 1.0 | 17.0 | 30.0 | 51 |
| * NT refers to the number of tumors / ablations |
Study Results
Primary Endpoint
The study demonstrated that the mean Dice coefficient for BTM compared to T=24 CECT was significantly higher than the mean Dice coefficient for T=0 CECT versus T=24 CECT (Table 7). This result highlights that BTM provides additional meaningful information that is correlative to the ablation zone visualized on T=24 CECT as compared to T=0 CECT.
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| Method | Mean | SD | Min | Median | Max | Lower
95%
CL | Upper
95%
CL | Nt | Paired
T-Test**
P-Value | Wilcoxon
P-Value |
|-------------------------------|------|------|------|--------|------|--------------------|--------------------|----|-------------------------------|---------------------|
| DICE BTM vs T=24
CECT | 85.5 | 6.8 | 56.0 | 87.0 | 94.0 | 83.6 | 87.4 | 51 | | |
| DICE T=0 CECT vs
T=24 CECT | 76.8 | 12.7 | 10.0 | 80.0 | 88.0 | 73.2 | 80.3 | 51 |