(266 days)
Not Found
Yes
The description mentions "Manual and automated tools for anatomic structures and ablation zone segmentation" and provides details on the training and test sets used for various segmentation algorithms (Liver, Liver Vessel, Ablation Target, Ablation Zone). While it doesn't explicitly use the terms "AI" or "ML," the use of automated segmentation algorithms trained on large datasets is a strong indicator of machine learning being employed for these tasks. The performance metrics like DICE score are also commonly used to evaluate the performance of segmentation models, including those based on ML. Furthermore, the predicate device, K202297, is named "Aline Ablation Intelligence," which strongly suggests the use of AI in a similar context.
No.
The device is a software package that assists physicians in planning and confirming liver ablation procedures, and does not directly provide therapy.
No
The "Intended Use / Indications for Use" section explicitly states: "The software is not intended for diagnosis."
Yes
The device is described as a "stand-alone software application" that runs on a "dedicated computer." While it processes images from CT scanners and PACS systems and assists with procedures involving physical ablation instruments, the device itself is solely the software and does not include any hardware components that are part of the regulated medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use explicitly states that the software is for processing CT images during liver ablation procedures to assist physicians in planning and confirming the procedure. It is not intended for diagnosis.
- Device Description: The device description details a software application that processes medical images (CT scans) to aid in surgical planning and confirmation. This involves image segmentation, registration, and measurement, all of which are typical functions of medical image processing software used in interventional procedures.
- Lack of In Vitro Component: IVDs are defined as reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of in vitro specimens. It processes in vivo imaging data.
The device falls under the category of medical image processing software used to support clinical procedures, specifically liver ablation. While it uses data derived from the human body (CT images), it does not perform in vitro testing on biological samples.
No
The letter explicitly states 'Not Found' under the 'Control Plan Authorized (PCCP) and relevant text' section, indicating there is no information about a cleared or approved PCCP for this device.
Intended Use / Indications for Use
VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures.
VisAble.IO is controlled by the user via a user interface.
VisAble.IO imports images from CT scanners and facility PACS systems for display and processing during liver ablation procedures.
VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Product codes (comma separated list FDA assigned to the subject device)
QTZ, LLZ and QIH
Device Description
VisAble.IO is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room.
VisAble.IO has five distinct workflow steps:
- . Data Import
- Anatomic Structures Segmentation (Liver, Hepatic Vein, Portal Vein, Ablation Target) .
- Instrument Placement (Needle Planning)
- . Ablation Zone Segmentation
- . Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)
Of these workflow steps, two (Anatomic Segmentation and Instrument Placement) make use of the planning image. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Seqmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's technical performance in the confirmation image volume.
Key features of the VisAble.IO Software include:
- Workflow steps availability
- Manual and automated tools for anatomic structures and ablation zone segmentation
- . Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images
- . Image fusion and registration
- . Compute achieved margins and missed volumes to help the user assess the coverage of the ablation target by the ablation zone
- . Data saving and secondary capture generation
The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones.
The software system runs on a dedicated computer and is intended for display and processing, of a Computed Tomography (CT), including contrast enhanced images.
The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment.
VisAble.IO uses several algorithms to perform operations to the user in order for them to evaluate the planned and post ablation zones. These include:
- . Seamentation
- . Image Registration
- . Measurement and Quantification
VisAble.IO is intended to be used for ablations with the following ablation instruments:
For needle planning, the software currently supports the following needle models:
- -Medtronic: Emprint Antenna 15CM, 20CM, 30CM
- NeuWave Medical: PR Probe 15CM, 20CM: PR XT Probe 15CM, 20CM: LK ー Probe 15CM, 20CM; LK XT Probe 15CM, 20CM
For treatment confirmation (including seqmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), including contrast enhanced images.
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Operating Room and the hospital healthcare environment such as interventional radiology control room.
Description of the training set, sample size, data source, and annotation protocol
The liver segmentation and liver vessel segmentation algorithms. The training and model validation dataset characteristics are as follows:
Liver Segmentation Alqorithm:
- . Patients
- 1091 contrast-enhanced CT images from arterial or venous phases in axial . orientation
- Age distribution: 50.70 ± 24.14 .
- Sex distribution: 34.58% female, 65.42% male ●
- Location of clinical sites: Germany, France, Turkey, Japan, Israel, Netherlands, . Canada, USA, UK
- . Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading
- . Number of clinical sites: 38
Liver Vessel Segmentation Algorithm:
- Patients ●
- N=393 contrast-enhanced CT images from the portal-venous or late venous . phases in axial orientation
- . Age distribution: 51.40 ± 22.81
- Sex distribution: 37.43% female, 62.57% male ●
- Location of clinical sites: Central Europe, North America, East Asia .
- Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading in liver . diaanosis
- . Number of clinical sites: 36
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing (Bench) was performed on the following features, to ensure that performance and accuracy was as expected:
- . Segmentation post-processing Testing
- . Image Registration Testing
- Measurement and Quantification Testing
Algorithm validation results:
- Liver Segmentation: N=50, Primary Performance Goal: Mean DICE =0.92, Primary Endpoint: Mean DICE =0.98
- Ablation Target Segmentation: N=59, Primary Performance Goal: Mean DICE = 0.70, Primary Endpoint: Mean DICE = 0.80
- Ablation Zone Segmentation: N=59, Primary Performance Goal: Mean DICE = 0.70, Primary Endpoint: Mean DICE = 0.86
- Liver Vessels Segmentation: N=100, Primary Performance Goal: Mean DICE = 0.70, Primary Endpoint: Mean DICE = 0.72
- PrePost Ablation Image Registration: N=46, Primary Performance Goal: MCD*= 6.06 mm, Primary Endpoint: MCD*=4.11 mm
*MCD=Mean Corresponding Distance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean DICE, Mean Corresponding Distance (MCD)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
TechsoMed Medical Tehnologies, Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Suite 2300 PHILADELPHIA PA 19103
August 28, 2023
Re: K223639
Trade/Device Name: VisAble.IO Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ, LLZ and QIH Dated: July 31, 2023 Received: August 1, 2023
Dear Janice Hogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known)
Device Name
VisAble.IO
Indications for Use (Describe)
VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures.
VisAble. IO is controlled by the user via a user interface.
VisAble.IO imports images from CT scanners and facility PACS systems for display and processing during liver ablation planning.
VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR | ☐ |
区 Prescription Use (Part 21 CFR 801 Subpart D) 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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- Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs .gov
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510(k) SUMMARY TechsoMed's VisAble.IO K223639
Submitter
TechsoMed Medical Technologies. LTD. Meir Weisgal 2 Rehovot Israel Phone: +972-545595951
Contact Person: Dalia Dickman, PhD.
Date Prepared: August 23rd, 2023
Name of Device: VisAble.IO
Common or Usual Name: VisAble.IO
Classification Name: Medical Image Management and Processing System (21 CFR 892.2050)
Regulatory Class: Class II
Product Code: QTZ, QIH, LLZ
Predicate Devices
| 510(k) Number | K202297 |
|---|---|
| Trade Name | Aline Ablation Intelligence |
| Manufacturer | Mirada Medical Ltd |
| Device Name | Aline Ablation Intelligence |
| Regulation Number | 892.2050 |
| Regulation Name | Picture Archiving and Communications System |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
Device Description
VisAble.IO is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room.
VisAble.IO has five distinct workflow steps:
- . Data Import
- Anatomic Structures Segmentation (Liver, Hepatic Vein, Portal Vein, Ablation Target) .
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- Instrument Placement (Needle Planning)
- . Ablation Zone Segmentation
- . Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)
Of these workflow steps, two (Anatomic Segmentation and Instrument Placement) make use of the planning image. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Seqmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's technical performance in the confirmation image volume.
Key features of the VisAble.IO Software include:
- Workflow steps availability
- Manual and automated tools for anatomic structures and ablation zone segmentation
- . Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images
- . Image fusion and registration
- . Compute achieved margins and missed volumes to help the user assess the coverage of the ablation target by the ablation zone
- . Data saving and secondary capture generation
The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones.
The software system runs on a dedicated computer and is intended for display and processing, of a Computed Tomography (CT), including contrast enhanced images.
The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment.
VisAble.IO uses several algorithms to perform operations to the user in order for them to evaluate the planned and post ablation zones. These include:
- . Seamentation
- . Image Registration
- . Measurement and Quantification
VisAble.IO is intended to be used for ablations with the following ablation instruments:
For needle planning, the software currently supports the following needle models:
- -Medtronic: Emprint Antenna 15CM, 20CM, 30CM
- NeuWave Medical: PR Probe 15CM, 20CM: PR XT Probe 15CM, 20CM: LK ー Probe 15CM, 20CM; LK XT Probe 15CM, 20CM
For treatment confirmation (including seqmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings.
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Intended Use / Indications for Use
VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures.
VisAble.IO is controlled by the user via a user interface.
VisAble.IO imports images from CT scanners and facility PACS systems for display and processing during liver ablation procedures.
VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Technological Characteristics Comparison
Both the subject and predicate device are stand-alone software applications with tools and features designed to assist users in planning liver ablation procedures as well as tools for treatment confirmation. The use environment for both the subject and predicate device is the Operating Room and the hospital healthcare environment such as interventional radiology control room. Both the subject and predicate device have the same five distinct workflow steps:
- Data Import
- · Anatomic Structures Segmentation (Ablation Target Segmentation only for Aline Ablation Intelligence)
- · Instrument Placement (Needle Planning)
- · Ablation Zone Segmentation
- Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)
The following technological differences exist between the subject and predicate devices:
The primary difference between devices is that the subject device includes an additional software feature to the user that provides initial 3D segmentation of vessels and anatomy of the liver. In addition, while the predicate device supports image processing of both Computed Tomography (CT) as well as Magnetic Resonance (MR), the subject device supports image processing of CT only. A table comparing the key features of the subject and predicate devices is provided below.
| Characteristic | VisAble.IO | Aline Ablation Intelligence |
|---|---|---|
| 510(K) number | K223639 | K202297 |
| Classification | Class II. 892.2050 QTZ, QIH, LLZ | Class II. 892.2050 LLZ |
| Indications for Use | VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures. |
VisAble.IO is controlled by the user via a user interface.
VisAble.IO imports images from CT scanners and facility PACS systems for display and processing during liver ablation procedures.
VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying ablation targets and virtual ablation needle placement.
VisAble.IO is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success. | Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
Aline Ablation Intelligence is controlled by the user via a user interface on a workstation.
Aline Ablation intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success. |
| Target Population | The intended patient population is the patient demographic chosen by interventional radiologists to undergo ablation treatment (including patient with soft tissue lesions). | The intended patient population is the patient demographic chosen by interventional radiologists to undergo ablation treatment (including patient with soft tissue lesions). |
| Where Used | The application's use environment is the Operating Room and the hospital healthcare environment such as interventional radiology control room. | The application's use environment is the Operating Room and the hospital healthcare environment such as interventional radiology control room. |
| Energy Used | None - software only application. The software application does not deliver or depend on energy delivered to or from patients | None - software only application. The software application does not deliver or depend on energy delivered to or from patients |
| Intended Users | Physicians | Physicians |
| Design:
Supported
modalities | CT | CT;MRI |
| Design: Data
Visualization | Window and level, pan, zoom, cross-
hairs, slice navigation | Window and level, pan, zoom, cross-
hairs, slice navigation |
| Design; Image
Segmentation | Tools for segmenting 3D VOIs, including
target tissues, ablation zones, vessels
and anatomy of the liver. | Tools for segmenting 3D VOIs, including
target tissues and ablation zones. |
| Design: Image
registration | Registration of multiple images into a
single view. | Registration of multiple images and
imaging modalities into a single view. |
| Design:
Ablation zone
confirmation | Registration of the planning scan,
containing the identified target tissue,
with the confirmation scan showing the
ablation zone. The delineated target
tissue on the planning scan is then
projected onto the confirmation scan and
overlaid onto the delineated ablation
zone segmentation. This helps the user
in analyzing if the ablation zone covers
the target tissue with the desired amount
of margin. | Registration of the planning scan,
containing the identified target tissue,
with the confirmation scan showing the
ablation zone. The delineated target
tissue on the planning scan is then
projected onto the confirmation scan and
overlaid onto the delineated ablation
zone segmentation. This helps the user
in analyzing if the ablation zone covers
the target tissue with the desired amount
of margin. |
| Design: Save
key images | Key images can be acquired which may
be saved locally. | Key images can be acquired which may
be saved back to PACS or any DICOM
nodes. |
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Performance Data
VisAble.IO 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 performance, functional and algorithmic testing demonstrate that VisAble.IO meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.
Performance testing (Bench) was performed on the following features, to ensure that performance and accuracy was as expected:
- . Segmentation post-processing Testing
- . Image Registration Testing
- Measurement and Quantification Testing
The liver segmentation and liver vessel segmentation algorithms. The training and model validation dataset characteristics are as follows:
Liver Segmentation Alqorithm:
- . Patients
- 1091 contrast-enhanced CT images from arterial or venous phases in axial . orientation
- Age distribution: 50.70 ± 24.14 .
- Sex distribution: 34.58% female, 65.42% male ●
- Location of clinical sites: Germany, France, Turkey, Japan, Israel, Netherlands, . Canada, USA, UK
- . Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading
- . Number of clinical sites: 38
Liver Vessel Segmentation Algorithm:
- Patients ●
- N=393 contrast-enhanced CT images from the portal-venous or late venous . phases in axial orientation
- . Age distribution: 51.40 ± 22.81
- Sex distribution: 37.43% female, 62.57% male ●
- Location of clinical sites: Central Europe, North America, East Asia .
- Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading in liver . diaanosis
- . Number of clinical sites: 36
The following table provides a summary of the validation results:
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| Algorithm | N | Gender | Mean Age | N per Region | CT Brand | Primary Performance Goal | Primary Endpoint |
|---|---|---|---|---|---|---|---|
| Liver Segmentation | 50 | M: 52% | |||||
| F: 48% | 60.6 | US: 32 | |||||
| OUS: 18 | GE Medical Systems, | ||||||
| Siemens | Mean DICE =0.92 | Mean DICE =0.98 | |||||
| Ablation Target | |||||||
| Segmentation | 59 | M: 54% | |||||
| F: 46% | 60.0 | US: 30 | |||||
| OUS: 29 | GE Medical Systems, | ||||||
| Siemens, | |||||||
| Philips | Mean DICE = 0.70 | Mean DICE = 0.80 | |||||
| Ablation Zone | |||||||
| Segmentation | 59 | M:64% | |||||
| F: 36% | 66.0 | US: 30 | |||||
| OUS: 29 | GE Medical Systems, | ||||||
| Siemens | Mean DICE = 0.70 | Mean DICE = 0.86 | |||||
| Liver Vessels | |||||||
| Segmentation | 100 | M: 52% | |||||
| F: 48% | 58.5 | US: 72 | |||||
| OUS: 28 | GE Medical Systems, | ||||||
| Siemens | Mean DICE = 0.70 | Mean DICE = 0.72 | |||||
| PrePost Ablation | |||||||
| Image | |||||||
| Registration | 46 | M: 59% | |||||
| F: 41% | 63.3 | US: 13 | |||||
| OUS: 33 | GE Medical Systems, | ||||||
| Siemens, | |||||||
| Philips | MCD*= 6.06 mm | MCD*=4.11 mm |
*MCD=Mean Corresponding Distance
VisAble.IO provides functions including linear distance measurements and volumetric measurements. The resolution of the medical image data directly affects the ability of the user to make definitive measurements, especially when the sizes of structures to identify, segment or measure are near the resolution of the image data. The software's functions are dependent on the user actions as well as on the available information in the provided medical image data.
Segmentation tools provided within VisAble.IO include manual and semiautomated segmentation, and system post-processing of segmentations to remove 2D-holes and/or disconnected 3D regions present. The use of the seqmentation tools to achieve a satisfactory delineation of ablation target or ablation zone is a user operation and the clinical accuracy of segmentation is the responsibility of the user and not a VisAble.IO function.
Registration tools provided within VisAble.IO include automated local rigid registration within a region of interest around user-segmentations of ablation targets and ablation zones. Final accuracy of registration is dependent on user assessment and manual modification of the registration prior to acceptance, and not a VisAble.IO function.
Measurements of the achieved margins and missed volumes, calculated by comparing the segmentations, are presented by the system following user acceptance of segmentations and registration as clinically accurate. Accuracy of linear distance measures calculated by VisAble.IO are dependent on the image resolution.
Test planning was performed in accordance with standard testing procedures and guidelines 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 edition of VisAble.IO 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.
Potential risks were analyzed and satisfactorily mitigated in the device design.
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Based on the use-related risk analysis, it was determined that all potential use errors identified would not result in serious harm to patients or operators. Risk controls were also added to mitigate the use-related risks as much as possible, and the potential harm remains low. Therefore, no critical tasks were identified and human factors validation testing is not required to evaluate the use-related risks.
Conclusions
The VisAble.IO is as safe and effective as the Aline Ablation Intelligence. The VisAble.IO has the same intended uses and similar indications, technological characteristics, and principles of operation 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 VisAble.IO and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the VisAble.IO is as safe and effective as the Aline Ablation Intelligence. Thus, the VisAble.IO is substantially equivalent to the predicate device.