Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the NEUWAVE Microwave Ablation System user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.

Device Description

AC is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol.

AC contains a wide range of image processing tools, including:

2D image manipulation
3D image generation (from 2D images)
3D image manipulation
Region of interest (ROI) identification, segmentation and measurement
Automatic identification of ablation probes
Registration of multiple images into a single view

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeuWave Medical, Inc.'s Ablation Confirmation device, based on the provided FDA 510(k) summary:

This device is primarily an imaging processing software, and the documentation focuses on its functionality and user interface rather than a clinical outcome study. Therefore, the "performance data" section emphasizes verification and validation testing against a test plan and pre-determined acceptance criteria, rather than a traditional clinical trial or MRMC study.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list a table of quantitative acceptance criteria and their corresponding performance metrics as would be seen for an AI diagnostic device. Instead, it states:

Acceptance Criteria Category	Reported Device Performance
Overall Functionality	"Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software."
Meeting Pre-determined Criteria	"The system passed all pre-determined acceptance criteria identified in the test plan."
Compliance with Regulations/Guidance	"Verification and validation testing were completed 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”."
Risk Mitigation	"Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling."
Substantial Equivalence (Safety & Effectiveness)	"This version of the AC software does not present any new questions of safety or effectiveness."

The document details numerous "Modifications" and compares "Feature/Specification" between the subject device and the predicate device. These comparisons implicitly define the acceptance criteria, which seem to be primarily functional and qualitative:

Improved automatic probe detection feature: Expected to perform better or at least as well as the predicate.
New feature for manual probe definition: Expected to work as intended.
Network communication monitoring: Expected to function as a troubleshooting aid.
Improvements to target/ablation zone edit tools: Expected to allow selection for single or multiple slices.
Undo/redo capability for segmentation operations: Expected to function correctly.
Importation of fused PET (and MR) scan for comparison: Expected to perform this display function without manipulation, processing, or registration.
Viewing Set Up scan as a comparison scan: Expected to function as a comparison option.
Rendering objects as semi-transparent: Expected new visualization.
Image registration improvements (manual registration, undo): Expected to function as described and improve user experience.
New function to measure distance between probe tips: Expected to perform this measurement.
Displaying diameter of sphere during placement/sizing: Expected to show this information.

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

Sample Size: The document does not specify a numerical sample size for "test sets" in terms of cases or patient data. The "Performance Data" section broadly refers to tests performed on "all functions." This suggests the testing was more akin to software verification and validation, likely using diverse test cases rather than a statistically powered clinical dataset.
Data Provenance: Not explicitly stated. Given it's a software update (510k for modifications), it's highly probable that existing CT images (potentially from a variety of sources/countries, retrospective) were used for testing various functionalities. No indication of prospective data collection for this submission.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for this specific 510(k) submission. The device is described as assisting physicians, and its functions (segmentation, probe detection, registration) are user-controlled or semi-automatic with user adjustment. The "ground truth" for verifying its functions would likely be defined by internal testing against expected algorithmic outputs or manual verification by engineers against known inputs.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. This is consistent with the nature of the submission being about software updates and functional verification, not a clinical diagnostic assessment requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or mentioned. The device's indications for use emphasize "assisting physicians" and "not intended for diagnosis," positioning it as a tool to enhance existing procedures rather than a standalone diagnostic or a system intended to directly replace human interpretation. The claim is about functional equivalence and improvement, not comparative reader performance.

6. Standalone (Algorithm Only) Performance

The document does not present specific "standalone" performance metrics (e.g., sensitivity, specificity, or object detection accuracy) for its automatic features (like automatic probe detection, or segmentation algorithms). The software is designed to be "user-controlled" and provide "assistance." For instance, for segmentation, "The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion." This implies a human-in-the-loop design where the final decision and potentially the refinement of the algorithm's output rest with the user.

7. Type of Ground Truth Used

Given the nature of the software (image processing and visualization), the "ground truth" for its testing would effectively be the expected output or behavior of the software for given inputs. For example:
- Functional Ground Truth: Does the "undo" button correctly undo the last action? Does the 3D rendering rotate as expected?
- Algorithmic Ground Truth: Does the automatic probe detection correctly identify probes in a test image (which might be verified manually by an engineer or a simulated ground truth).
- User Experience Ground Truth: Are the "improvements to the target/ablation zone edit tools" functioning as intended for user adjustment?
  There is no mention of "pathology" or "outcomes data" as ground truth, as the device is not intended for diagnosis or determining clinical outcomes.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its size. This device is presented more as a deterministic image processing and visualization tool with semi-automatic features, rather than a deep learning/AI model that typically requires large training datasets. While some "segmentation algorithms" and "automatic probe detection" features might have involved some form of machine learning or rule-based training during their initial development (prior to this 510(k) in 2019), this documentation focuses on the modifications and their functional testing, not the underlying model development.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, there's no information on how its ground truth might have been established.

Summary

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October 3, 2019

NeuWave Medical, Inc. % Neda Chini Senior Regulatory Affairs Program Lead 3529 Anderson Street MADISON, WI 53704

Re: K192427

Trade/Device Name: Ablation Confirmation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 4, 2019 Received: September 5, 2019

Dear Neda Chini:

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

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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 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 medical devices and radiation-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,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K192427

Device Name Ablation ConfirmationTM

Indications for Use (Describe)

Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the NEUWA VE Microwave Ablation System user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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K192427

Date:Subject:	08/28/2019510(k) Summary of Safety and Effectiveness Information for NeuWaveMedical's Ablation Confirmation™ image processing software
Company:	NeuWave Medical, Inc.3529 Anderson StreetMadison, WI 53704
FDA Establishment#	3008769756
Contact:	Neda Chini, Senior Regulatory Affairs Program LeadP – 949-789-8656F - 608-512-1509
Proprietary:Classification:	Ablation Confirmation™ Common: Computed Tomography X-ray SystemRadiology, JAK, 21 CFR 892.1750

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

Predicate Devices

Ablation Confirmation™ is substantially equivalent to the following currently marketed device:

Ablation Confirmation Software Class II 21CFR892.1750, Radiology, JAK, which has . been the subject of a cleared 510(k) with the FDA log number K171022.

Indications For Use

Device Description

AC contains a wide range of image processing tools, including:

2D image manipulation
3D image generation (from 2D images)
3D image manipulation
Region of interest (ROI) identification, segmentation and measurement
Automatic identification of ablation probes
. Registration of multiple images into a single view

Ablation Confirmation 510(k) Submission Safety Summary Page 1 of 6

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Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image.

Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure probe(s) placement prior to starting the ablation.

Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semiautomatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure.

All AC processing and viewing is accomplished at the NEUWAVE Microwave Ablation System without the physician having to leave the procedure area to utilize separate image processing tools.

Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.

Modifications

This 510(k) was submitted to update the Ablation Confirmation software with the following modifications:

. Improved automatic probe detection feature
. New feature for manual probe definition available for users when the software cannot automatically detect the ablation probes.
. Network communication monitoring – a new convenience feature to aid in troubleshooting network connectivity issues.
Removed "Remote Viewing" feature based upon customer feedback
Improvements to the target/ablation zone edit tools to allow the user to select if they want to edit a single slice or multiple slices
An "undo/redo" capability for segmentation operations was added.
. Allow importation of a fused Positron Emission Tomography (PET) scan for use as a comparison scan. The fused images are created by another device and transmitted as a DICOM Secondary Capture image. Note that the fused PET/CT images are not able to be manipulated, processed or registered to another image using AC software. This feature addition simply allows fused PET/CT scans to be displayed as a "Comparison" scan within the existing AC construct. No measurements are allowed on the fused PET/CT scans.
. Allow the user to view the Set Up scan as a comparison scan when viewing the Evaluate Ablation screen.
Render targets, ablations and ablation probes as semi-transparent (as opposed to opaque) to allow for better visualization of the objects relative to each other.

Ablation Confirmation 510(k) Submission Safety Summary Page 2 of 6

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Image registration improvements that include a "manual registration" process in place of ● the previous "Refine Registration" feature. Also, the addition of "undo" in the registration workflow as a user convenience feature.
. New function to measure the distance between probe tips when multiple probes are used.
. Displaying the diameter of the sphere when the user is placing/changing the size of a sphere to provide the user with additional information compared with previous software versions.

Feature/Specification		Predicate: Ablation Confirmation SoftwareV2.3.0 (K171022)		Same aspredicate	Comments/impact onsafety and effectiveness
	Subject Device: AblationConfirmation SoftwareV3.1.0
Indication for Use	Ablation Confirmation™(AC), is a ComputedTomography (CT) imageprocessing softwarepackage available as anoptional feature for usewith the NEUWAVEMicrowave AblationSystem. AC is controlled bythe user via anindependent user interfaceon a second monitorseparate from theNEUWAVE MicrowaveAblation System userinterface. AC importsimages from CT scannersand facility PACS systemsfor display and processingduring ablationprocedures. AC assistsphysicians in identifyingablation targets, assessingproper ablation probeplacement and confirmingablation zones. Thesoftware is not intendedfor diagnosis.	Ablation Confirmation™(AC), is a ComputedTomography (CT) imageprocessing softwarepackage available as anoptional feature for usewith the Certus® 140 2.45GHz Ablation System. AC iscontrolled by the user viaan independent userinterface on a secondmonitor separate from theCertus 140 user interface.AC imports images from CTscanners and facility PACSsystems for display andprocessing during ablationprocedures. AC assistsphysicians in identifyingablation targets, assessingproper ablation probeplacement and confirmingablation zones. Thesoftware is not intendedfor diagnosis.		Yes	No changes to theIndication For Use. Theproduct name of theablation system wasupdated to reflect abranding/name change.
Image Acquisition	The system is capable ofretrieving CT image data,conforming to the DICOMstandard. Additionally,fused PET images and MRimages can be importedfor the comparison scanfeature.	The system is capable ofretrieving CT image data,conforming to the DICOMstandard. Additionally, MRimages can be importedfor the comparison scanfeature.		No	The fused PETimages are createdby another deviceand transmitted as aDICOM SecondaryCapture image.Note that the fusedPET/CT images arenot able to be
Feature/Specification	Subject Device: AblationConfirmation SoftwareV3.1.0	Predicate: AblationConfirmation SoftwareV2.3.0 (K171022)	Same aspredicate	Comments/impact onsafety and effectiveness
				processed orregistered toanother image usingAC software. Thisfeature additionsimply allows fusedPET/CT scans to bedisplayed as a"Comparison" scanwithin the existingAC construct. Nomeasurements areallowed on thefused PET/CT scans.
3D ImageManipulation	The system provides tools tomanipulate the 3D imagerendering. These toolsinclude:• Rotation• Pan/Zoom• Window/Level• Distance betweentips when multipleprobes are detected	The system provides tools tomanipulate the 3D imagerendering. These toolsinclude:• Rotation• Pan/Zoom• Window/Level	No	Addition of distancebetween probe tipmeasurement as aconvenience feature forusers. No new risks orrequired risk mitigationswere identified and noimpact on safety oreffectiveness.
Region of Interest(ROI) Identification	The system allows the user tosemi-automatically defineregions of interest on CTimages. A single-step "undo"function was added to thisfeature.	The system allows the user tosemi-automatically defineregions of interest on CTimages.	No	"Undo" is a minor changeand convenience featurefor users. No new risks orrequired risk mitigationswere identified and noimpact to safety oreffectiveness.
ROI Measurements	The system allows the user toassess the volume of thedefined ROIs.	The system allows the user toassess the volume of thedefined ROIs.	Yes	No changes in thissubmission
Desired MarginIdentification	The system allows the usersto draw on the ROI images tovisualize a user-determineddesired margin for theablation procedure.	The system allows the usersto draw on the ROI images tovisualize a user-determineddesired margin for theablation procedure.	Yes	No changes in thissubmission
Registration	The system can performdeformable registration ontwo distinct CT images. Theuser can manually adjust theresults of the registrationprocess. Replaced 'RefineRegistration' capability with a'Manual Registration'capability. When using themanual registration, the user	The system can performdeformable registration ontwo distinct CT images. Theuser can manually adjust theresults of the registrationprocess.	No	Automatic registrationalgorithms and mechanismsremain unchanged. Themanual registration optionmethodology has changedand an "undo" feature wasadded. No new risks wereidentified, no new riskmitigations were required
Feature/Specification	Subject Device: AblationConfirmation SoftwareV3.1.0	Predicate: AblationConfirmation SoftwareV2.3.0 (K171022)	Same aspredicate	Comments/impact onsafety and effectiveness
	has the option of turning offthe deformations computedby the deformableregistration.			and no impact to safety oreffectiveness.
Probe Identification	The system can automaticallyidentify ablation probeswithin the scan. AC can detectup to 3 probes.The software also enables theuser to manually draw probes	The system can automaticallyidentify ablation probeswithin the scan. AC can detectup to 3 probes.	No	Continuous improvementof existing probe detectionfeature. Ability to manualdraw probes is a minorfeature addition to improvefeature set.
Probe placementAssessment	The system, using thedeformable registrationprocess, can visualize theposition of the ablationprobe(s) in relation to theROI.	The system, using thedeformable registrationprocess, can visualize theposition of the ablationprobe(s) in relation to theROI.	Yes	No changes in thissubmission
Ablation ZoneAssessment	Using the same process asROI identification, the systemallows the user to semi-automatically identify theablation zone following anablation procedure.	Using the same process asROI identification, the systemallows the user to semi-automatically identify theablation zone following anablation procedure.	Yes	No changes in thissubmission
Allows User toAccount for TissueContraction	Yes	Yes	Yes	No changes in thissubmission
Assessing thetechnical success ofthe ablationprocedure.	Using the same deformableregistration process, imageset with ablation zone can beoverlaid onto the image setwith the initial ROIsegmentation to helpphysicians determine thetechnical success of anablation procedure.Allow user to view the Set Upscan next to the EvaluateAblation scan.	Using the same deformableregistration process, imageset with ablation zone can beoverlaid onto the image setwith the initial ROIsegmentation to helpphysicians determine thetechnical success of anablation procedure	No	This change is a minorworkflow enhancementbased upon user feedback.No new risks or requiredrisk mitigations wereidentified and no impact tosafety or effectiveness.

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Performance Data

Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan.

Verification and validation testing were completed 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". Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling.

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Substantial Equivalence Discussion

Ablation Confirmation™ is substantially equivalent in design concepts, technologies and materials to the identified predicate. This version of the AC software does not present any new questions of safety or effectiveness.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.