Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.

Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.

The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

Device Description

Ablation-fit is a stand-alone medical imaging software that integrates Reconstruction, Segmentation, Registration and Visualization algorithms into a user interface to support physicians during liver ablation treatments planning and follow-up.

Ablation-fit allows to perform the entire workflow from DICOM (Digital Imaging and COmmunications in Medicine) images to 3D reconstruction of volume of interests, ablation probe placement and treatment outcome verification.

Specifically, Ablation-fit main functionalities include:

Image loading from different supports (including PACS),
DICOM images handling and visualization in axial, sagittal, coronal views,
image segmentation,
tools for manual edit of segmentations.
3D visualization,
virtualization of ablation probe placement,
pre- and post-treatment images registration.

The software permits segmentation and 3D reconstruction of volumes of interest. The software contours all of this anatomic information not only in axial, sagittal, and coronal planes for 2D visualization, but also three-dimensionally. Every computed segmentation can be manually modified in the 2D axial visualization and consequently the three-dimensional mapping of the scan changes accordingly.

Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation.

Once the ablation procedure has been performed, pre- and post-treatment scans are registered. Consequently, the software can verify whether the ablation zones entirely surrounds the lesion and the safety margin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Ablation-fit device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The document doesn't present a direct table of specific acceptance criteria with corresponding performance metrics in a single, clear format. However, it states that "software testing using retrospective image data of ablation procedures" was conducted to evaluate "the accuracy of Ablation-fit in assessing the outcome of lesion percutaneous thermal ablations and the accuracy of the automatically performed segmentations." It also mentions "Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected."

Based on these statements, we can infer the following general acceptance criteria and reported performance:

Acceptance Criteria Category	Reported Device Performance
Segmentation Accuracy	Algorithms performed as expected (compared to qualified expert-annotated ground truth). Retrospective evaluation showed accuracy in automatically performed segmentations.
Registration Accuracy	Algorithms performed as expected (compared to qualified expert-annotated ground truth).
Assessment of Ablation Outcome Accuracy	Retrospective evaluation showed accuracy in assessing the outcome of lesion percutaneous thermal ablations.
Measurement Accuracy	Measurement Accuracy Test performed to evaluate the accuracy of measurements carried out with Ablation-fit software on CT images. (Specific metrics not provided in this summary).
Functionality (User Interaction)	All semi-automatic functionalities underwent testing by three radiologists to account for variability resulting from user interaction, and the system satisfied user demands and requirements. (Specific metrics not provided, but implies satisfactory performance with user variability accounted for).
Compliance with Standards & Requirements	Designed and developed according to ANSI AAMI IEC 62304:2006/A1:2016. Software verification and validation testing conducted according to FDA guidance. User acceptance test performed according to ANSI AAMI IEC 62366-1:2015+AMD1:2020.
Safety and Effectiveness Equivalence	Functions at least as safely and effectively as the designated predicate device and is essentially equivalent to it. Does not introduce any new potential safety risks.

Study Details

Here's the breakdown of the study information:

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

Sample Size for Test Set: The exact number of cases or images in the "retrospective image data of ablation procedures" used for software testing is not specified in this document.
Data Provenance: The data used for testing was "retrospective image data of ablation procedures." The country of origin for the data is not specified.

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

Number of Experts: "Qualified experts" were used to annotate ground truth for segmentation and registration processes. In addition, "three radiologists" performed testing for semi-automatic functionalities to account for user interaction variability.
Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of the "qualified experts" and the "three radiologists" are not specified beyond their profession.

4. Adjudication Method for the Test Set

The document implies that ground truth was "annotated by qualified experts." For the "semi-automatic functionalities," testing involved "three radiologists" to account for user variability. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth, particularly expert consensus for discrepancies. It's possible annotation by a single "qualified expert" was considered ground truth, or an unstated consensus method was used.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The testing involved "three radiologists" testing "semi-automatic functionalities to account for variability resulting from user interaction," but this appears to be part of validating the device's interaction and robustness, not a comparative effectiveness study of human readers with vs. without AI assistance.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: This information is not provided as an MRMC study was not described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was conducted for some aspects. The document states: "Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected." This implies an evaluation of the algorithm's performance in these tasks independent of a human user's interaction in the final output generation.
Additionally, "the accuracy of the automatically performed segmentations" was evaluated, which is a standalone assessment.

7. The Type of Ground Truth Used

The primary type of ground truth used was expert consensus / expert annotation. Specifically, "ground truth annotated by qualified experts" was used for segmentation and registration processes.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not explicitly state how the ground truth for the training set was established. It only discusses the ground truth for the "test set" or "bench tests."

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 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.

R.A.W. Srl % Chiara Ferrari Q&R Officer Via Soperga 13 Milan, 20127 ITALY

September 12, 2023

Re: K222938

Trade/Device Name: Ablation-fit Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ Dated: August 10, 2023 Received: August 10, 2023

Dear Chiara Ferrari:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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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Indications for Use

510(k) Number (if known) K222938

Device Name Ablation-fit

Indications for Use (Describe)

Ablation-fit is a medical imaging application available for use with liver ablation procedures.

Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.

Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.

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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Manufacturer: R.A.W. S.r.1. Address: Via Soperga 13, 20127 Milan, Italy Phone: +39 3400747597

Contact Person: Chiara Ferrari Applicant Correspondent: Chiara Ferrari Email: quality@endo-sight.it Date Prepared: August 10th, 2023

II. Device

510(k) Number	K222938
Device Name	Ablation-fit
Trade or ProprietaryName:	Ablation-fit
Common or Usual Name:	Ablation-fit
Classification Name:	Medical image management and processing system
Primary Product Code:	QTZ
Regulation Number:	21 CFR 892.2050
Regulatory Class	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Primary predicate device:

Aline Ablation Intelligence Class II 21 CFR 892.2050, Radiology, LLZ, which has ● been the subject of a cleared 510(k) with the FDA log number K202297.

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	II
Primary Product Code	LLZ

Reference device:

The following reference device, which shares similar planning functions with Ablation-fit, is used in this submission to support the claim regarding the level of concern associated with Ablation-fit.

Visible Patient Suite- Class II 21 CFR 892.2050, Radiology, LLZ, which has ● been the subject of a cleared 510(k) with the FDA log number K212896.

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510(k) Number	K212896
Trade Name	Visible Patient Suite
Manufacturer	Visible Patient, SAS
Device Name	Visible Patient Suite
Regulation Number	892.2050
Regulation Name	Medical image management and processing system
Regulatory Class	II
Primary Product Code	LLZ

IV. Device Description

Specifically, Ablation-fit main functionalities include:

Image loading from different supports (including PACS),
DICOM images handling and visualization in axial, sagittal, coronal views,
image segmentation,
tools for manual edit of segmentations.
3D visualization,
virtualization of ablation probe placement,
pre- and post-treatment images registration. ●

Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation.

V. Indications for Use

Ablation-fit is a medical imaging application available for use with liver ablation procedures.

Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.

Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.

The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

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Characteristic	Ablation-fit	Aline AblationIntelligence	Equivalence
Manufacturer	R.A.W. s.r.l.	Mirada Medical Ltd	N/A
510(k) number	K222938	K202297	N/A
Classification	Class II. 892.2050 QTZ	Class II. 892.2050 LLZ	N/A
Clinicalequivalence	TargetPopulation	The intended patientpopulation of theAblation-fit software is thepatient demographicchosen by physicians toundergo liver ablationtreatment (includingpatient with soft tissuelesions).	The intended patientpopulation of the AlineAblation Intelligencesoftware is the patientdemographic chosen byphysicians to undergoablation treatment(includingpatient with soft tissuelesions).	Ablation-fittarget populationis limited to liverablationtreatment.
	Where used	The software is intendedto be used:• In operating rooms• In office environmentswithin hospitals	The application's useenvironment is theOperating Room and thehospital healthcareenvironment suchas interventional radiologycontrol room.	Equivalent
	Site in the body	Liver	Not specified	Ablation-fit isintended to beused only onliver
Intended Users	Physicians	Physicians	Equivalent
Technicalequivalence	Design	stand-alone desktopsoftware application withtools and featuresdesigned to assist users inplanning ablationprocedures as well as toolsfor evaluating ablationprocedure's outcome	stand-alone desktopsoftware application withtools and featuresdesigned to assist users inplanning ablationprocedures as well as toolsfor evaluating ablationprocedure's outcome	Equivalent
	Energy Usedand/orDelivered	None - software onlyapplication. The softwareapplication does notdeliver or depend onenergy delivered toor from patients	None - software onlyapplication. The softwareapplication does notdeliver or depend onenergy delivered toor from patients	Equivalent
	Supportedmodalities	Contrast-enhanced CT	CT, MR	Ablation-fit doesnot support MRmodalities
	Datavisualization	• 2D visualization tools:Window and level, pan,zoom, cross-hairs, slicenavigation.• 3D visualization of allsegmented abdomenstructures	• 2D visualization tools:Window and level, pan,zoom, cross-hairs, slicenavigation.• 3D visualization ofsegmentedtargets/ablation zones.	Ablation-fit canvisualize 3Dspatial renderingof all segmentedstructures. Theseadditionalanatomicalsegmentationshave the goal tohighlight thepresence of theanatomy to theuser when
		planning intervention
	Data segmentation	• Automatic segmentation for liver, spleen, bones, liver vessels, skin• Tools for interactive segmentation for liver, spleen and liver targets/ablation zone• Tools for manual segmentation editing and/or correction	• No automatic segmentation of organs• Tools for interactive segmentation of targets/ablation zone• Tools for manual segmentation editing and/or correction	Ablation-fit provides an automatic segmentation of abdomen organs
	Planning function	Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images	Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images	Equivalent
	Data registration	• Automatic image registration of pre- and post-treatment images• Blending tools to assess the correctness of the registration	• Automatic image registration of pre- and post-treatment images• Manual registration correction	Ablation-fit has not a manual registration correction, but it provides a tool for the assessment of the correctness of the registration
	Ablation confirmation function	Ablation-fit can perform registration of pre-treatment, containing the identified targets and post-treatment scans containing ablation zone. The segmented and registered volumes between the two scans (targets, ablation zones) are then showed together on the same scan and in 3D. In addition, different colors enhance the residual target volume and safety margins.	Aline Ablation Intelligence can perform a 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 to help the user in analyzing if the ablation zone covers the target tissue with the desired amount of margin.	Equivalent

VI. Comparison of Technological Characteristics

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Ablation-fit is substantially equivalent to its predicate device with respect to:

Image acquisition of CT images
Image segmentation of targets and ablation zones ●
. Segmentation interactive tools and possible manual corrections
3D visualization of targets and ablation zones ●
Virtual ablation needles and user-selected estimates of the ablation regions onto the medical . images
Automatic image registration of pre- and post-treatment images .

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Overlay of targets and ablation zones in 3D and 2D visualization
The main differences between Ablation-fit and its predicate device concern the following aspects:
Ablation-fit is intended to be used only for liver ablation procedures ●
Ablation-fit is not intended to be used with MR images. This is clearly stated on labeling and ● indication for use.
. Ablation-fit performs image segmentation of abdominal structures, enabling computation of 3D volumes and providing accurate 3D representations of segmented structures and their spatial relationships. This allows the highlighting of anatomical structures to the user when planning interventions. In the predicate device, only targets and ablation zones are 3D segmented. Nevertheless, all segmentation processes underwent extensive validation, demonstrating their compliance with acceptance criteria. Moreover, the reference device we have included in this submission (Visible Patient Suite - K212896) presents similar functions for organ segmentation (including liver, bones, vessels) and is used for planning purposes, as specified in its intended use.
Ablation-fit does not provide manual registration correction. Instead, Ablation-fit permits to assess the correctness of the image registration providing the blending tool.

The subject software has the similar intended use and technological/functional features as its predicate device in providing tools and workflow designs to support physicians during liver ablation treatments planning and follow-up. The slight differences between the subject and predicate device (supported modalities, data visualization and data segmentation, data registration) do not raise new questions of safety and effectiveness as demonstrated by verification activities. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of Ablation-fit to the identified predicate device.

VII. Performance Data

Ablation-fit was designed and developed according to the software life-cycle process described in ANSI AAMI IEC 62304:2006/A1:2016.

First, a design and development project plan was defined, together with software requirements. They were transformed into software design specifications and software architecture. Specific tests are then planned and performed to verify both software units and software integration of the requirements. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".

Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected. Additionally, all semi-automatic functionalities underwent testing by three radiologists to account for variability resulting from user interaction. Quantitative testing related to these topics has been performed according to "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance".

Also, a user acceptance test was performed according to ANSI AAMI IEC 62366-1:2015+AMD1:2020. This user acceptance test performs both verification and validation of Ablationfit.

Measurement Accuracy Test was also performed in order to evaluate the accuracy of measurements carried out with Ablation-fit software on CT images.

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Additionally, to supplement the software validation for Ablation-fit, we conducted software testing using retrospective image data of ablation procedures. The purpose of such analysis was to retrospectively evaluate the accuracy of Ablation-fit in assessing the outcome of lesion percutaneous thermal ablations and the accuracy of the automatically performed segmentations.

Performance, functional, and algorithmic testing outcomes show that Ablation-fit satisfies the device's user demands and requirements, which are deemed to be substantially equivalent to those of the predicate device.

VIII. Conclusion

In conclusion, Ablation-fit functions at least as safely and effectively as the designated predicate device and is essentially equivalent to it, according to performance tests and device evaluations contained in this 510(k) submission. Ablation-fit meets requirements for safety and effectiveness and does not introduce any new potential safety risks.

Regulation Number and Section

§ 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).