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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, including the partial or complete ablation of non-resectable liver tumors, via applying microwave energy to produce tissue heating effects generating tissue necrosis.

The system consists of three major components:

• (1) The system 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) Power Distribution Module (PDM), which allows power to be transferred from the system generator to the ablation probes.
• (3) Range of microwave ablation probe accessories for energy delivery.

The system cart 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 Esized CO2 cylinders located on the back of the cart.

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 cart 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 probe. The probes can be used for Surgical Mode or Ablation Mode with various limits of maximum selectable power based on the probe type.

The antenna of the NEUWAVE PR probe family is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. NEUWAVE PR Probes were developed to provide physicians with an additional ablation probe option with a different ablation burn pattern compared with NEUWAVE LK/LN/SR probes. The NEUWAVE PR probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation compared with other NEUWAVE ablation probes.

There are 2 changes covered by this 510(k) submission:

• 1. A new Microwave Ablation Probe, the Surgical PR Probe (PRS35), available for use with the NEUWAVE System.
• 2. Updates to the NEUWAVE System software to accommodate the new PRS35 probe and to implement various enhancements to the user experience and correct minor software anomalies that do not impact safety or effectiveness.

The new NEUWAVE Surgical PR Ablation Probe (PRS35) has a 11/13-gauge and 35cm length cannula with a 2.9m cable in length. The proposed PRS35 probe uses a similar cannula and antenna design to the predicate probes PRS15 & NWSR25, and the ablation pattern also closely resembles the above stated predicate. The longer cannula length is a primary purpose of the new probe to enable access to targets farther from the skin surface due to insufflation in laparoscopic procedures.

The subject embedded software utilizes the existing firmware and software architecture design, technological characteristics and functions but incorporates enhancements and features as described below:

• Procedure Profiles
• PRS35 Probe Support ●
• Planning: Time and Power Guide available without probe ●
• Cybersecurity
• Misc. Bug fixes ●
• Additional Languages to support country specific registration globally (Finnish, Norwegian, Turkish)

No changes were made to the currently marketed family of NEUWAVE Ablation Probes nor to any hardware aspects of the currently marketed NEUWAVE system cleared under K220472.

The selection of available ablation probes provides physicians with the opportunity to select the length, stiffness, burn pattern and number of probes to use to create a wide variety of ablation zone sizes and shapes.

The provided text describes the 510(k) summary for the NEUWAVE™ Microwave Ablation System and Accessories, specifically focusing on the addition of a new probe (PRS35) and software updates. It states that all acceptance criteria were met, but it does not provide a detailed table of acceptance criteria with reported device performance, information on sample sizes, ground truth establishment methods, or the specifics of a study proving all acceptance criteria were met.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "All testing passed, and all acceptance criteria were met." however, it does not specify what those acceptance criteria were or provide a table of performance data against them.

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

Not available in the provided text. The document highlights "Nonclinical Testing" including "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," but does not explicitly state the sample sizes (e.g., number of probes, number of ex-vivo tissue samples) or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

Not applicable / Not available. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies). For a microwave ablation system, the "ground truth" for non-clinical performance likely refers to measurable physical outcomes (e.g., ablation zone size, temperature profiles) in ex-vivo tissue, which would not typically involve expert consensus in the same way. The document does not mention any expert involvement for establishing ground truth in the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable / Not available. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies. For the non-clinical performance testing of a microwave ablation system, this concept does not directly apply.

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

No. The document explicitly states: "No clinical data was generated in support of this Premarket 510(k) Notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly for the software updates. The submission includes "Software Verification and Validation" testing, which would assess the algorithm's performance in a standalone manner. However, no specific performance metrics of the software algorithm itself (e.g., accuracy of a particular feature) are provided. The software updates are described as accommodating the new PRS35 probe, implementing user experience enhancements, and correcting minor anomalies.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," the ground truth would likely be physical measurements (e.g., dimensions of the ablation zone, temperature reached) observed directly from the ex-vivo tissue after ablation. The document does not specify the exact methodology, but for such a device, these are standard methods.

8. Sample Size for the Training Set

Not applicable / Not available. The document describes a "510(k) premarket notification," which is for demonstrating substantial equivalence to a predicate device, not for a new device requiring a de novo clearance or PMA where extensive training data for AI/ML models might be detailed. The software updates mentioned are for "enhancements to the user experience and correct minor software anomalies" and "PRS35 Probe Support," not for developing a new AI/ML algorithm that would typically require a training set.

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

Not applicable. As the device submission does not describe the development of a new AI/ML algorithm requiring a training set, the establishment of ground truth for a training set is not relevant to the provided information.

Ask a specific question about this device

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.

Ask a specific question about this device

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, including the partial or complete ablation of non-resectable liver tumors, 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), (3) a range of microwave ablation probe accessories for energy delivery.

The provided text describes modifications to an existing microwave ablation system and does not contain information about an AI/ML powered device. Therefore, I cannot extract the acceptance criteria and study details as per your request, as the input document does not pertain to AI/ML device performance.

The document focuses on the NeuWave Microwave Ablation System and its accessories, specifically detailing changes and comparisons to predicate devices for a 510(k) submission. This is a medical device approval process based on substantial equivalence, not AI/ML performance metrics.

Ask a specific question about this device