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The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.

The NEUWAVE™ Microwave Ablation System is not indicated for use in cardiac procedures

The NEUWAVE™ Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue which applies microwave energy to produce tissue heating effects generating tissue necrosis.

The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), and (3) a range of microwave ablation probe accessories for energy delivery.

The system has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable.

The CO2 cooling system enables the Tissu-Loc function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two E-sized CO2 cylinders located on the back of the system.

The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc function.

Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system generator to the ablation probes.

The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probes can be used for surgical mode or ablation mode with various limits of maximum selectable power and time based on the probe type.

The NeuWave Medical Inc. NEUWAVE™ Microwave Ablation System and Accessories (K220472) underwent non-clinical testing to demonstrate substantial equivalence to its predicate device (K200081). The study focused on assessing electrical safety, electromagnetic compatibility, and ex-vivo tissue ablation to ensure that updated hardware and software components did not compromise the device's design and performance specifications.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a specific number of cases or samples. For electrical safety and EMC testing, "the NEUWAVE™ Microwave Ablation System with NEUWAVE™ Probes" was tested. For ex-vivo tissue ablation, the testing involved "ablation zone dimensions of the subject and predicate devices." This implies a sufficient number of tests were conducted to ensure comparability.
• Data Provenance: The studies were non-clinical design verification tests, performed by the manufacturer (NeuWave Medical Inc.) as part of their premarket notification. The data is prospective, generated specifically for this submission. The country of origin is implicitly the USA, where NeuWave Medical Inc. is based.

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

• This information is not provided as the studies were non-clinical, hardware, and software verification tests. The "ground truth" was established by engineering specifications, relevant IEC standards, and direct comparison of a physical characteristic (ablation zone dimensions) rather than expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set:

• This information is not applicable as the tests were non-clinical engineering and performance evaluations, not involving human interpretation or adjudication of medical data.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical data was generated or is required to support of this Premarket 510(k) Notification." The focus was on demonstrating substantial equivalence through non-clinical performance data due to minor hardware and software updates to an already cleared predicate device.

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

• The device is a physical microwave ablation system with embedded software, not a standalone algorithm in the typical sense of AI image analysis. The "software verification testing" was done in a standalone manner (evaluating the software itself), but it's not an "algorithm only without human-in-the-loop performance" that would typically be described for diagnostic AI tools. The system requires human operation for its intended use.

7. The Type of Ground Truth Used:

• For Electrical Safety and EMC: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2) served as the ground truth.
• For Ex-vivo tissue ablation: The "ground truth" was the physical measurement of ablation zone dimensions, compared directly between the subject and predicate devices for identical power settings. This is a direct physical measurement.
• For Software Verification: Compliance with FDA guidance for software in medical devices (functional correctness, robustness, etc.) served as the ground truth.
• For Cybersecurity: Conformance to FDA guidance on cybersecurity management.

8. The Sample Size for the Training Set:

• Not applicable. This submission focuses on a modified device and its non-clinical verification. It does not describe the development or training of a new AI algorithm that would typically involve a "training set" of data for machine learning. The software updates were primarily to support updated hardware due to component obsolescence, not to introduce new AI-driven functionalities requiring extensive data training.

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

• Not applicable. As no training set for an AI algorithm was described, the method for establishing its ground truth is not relevant to this submission.

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Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 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.

AC is resident on the Certus® 140 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 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

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 proper probe(s) placement prior to starting the ablation. Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semi-automatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC can then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The resulting image set includes the ablation zone overlaid onto the initial target lesion segmentation to help physicians 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 Certus® 140 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.

The acceptance criteria for the Ablation Confirmation™ device were based on the device successfully passing all pre-determined criteria identified in the test plan for its functions, including segmentation and registration accuracy. While the document states that these accuracies were demonstrated through adequate bench testing and clinical experience, it does not explicitly provide numerical acceptance criteria or reported performance metrics in a tabular format.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance:

The document states: "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."

However, specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum error margins) and the corresponding reported device performance values are not explicitly provided in this document. The document generally states that "Segmentation and Registration accuracy were demonstrated through adequate bench testing and also through clinical experience of qualified users."

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

• Sample Size: Not explicitly stated.
• Data Provenance: "Testing was performed using retrospectively obtained CT image series from ablation procedures." The country of origin for the data is not specified.

3. Number of Experts and Qualifications:

• Number of Experts: Not explicitly stated. The document refers to "clinical experience of qualified users" but does not quantify the number of users or their specific roles.
• Qualifications: "Qualified users" are mentioned, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method:

• The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth or evaluating the device's performance within the test set.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is described as assisting physicians, but a comparative study as described is not presented.

6. Standalone Performance:

• Yes, a standalone performance evaluation was conducted. The document states, "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." This implies an assessment of the algorithm's performance independent of human input, as its functions are described to "assist physicians" and "perform" certain tasks like segmentation and registration.

7. Type of Ground Truth Used:

• The ground truth appears to be based on expert interpretation and manual adjustments. For target lesions, 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." A similar process is described for the ablation zone. This suggests that the "true" segmentation or identification was ultimately confirmed and potentially modified by a qualified user. This combines algorithmic output with expert consensus/manual correction.

8. 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 describe how the ground truth for the training set was established. It describes the process for how the device assists in segmentation during an actual procedure, which involves physician initiation and manual adjustment of the algorithmic output. While this provides insight into the intended use and validation approach, it doesn't detail the training data ground truth establishment.

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