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ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.

ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ 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. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.

ABLATE-IQTM 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)/target identification, segmentation, and measurement
• · Image-based detection of ablation probes manually placed by the user (physician)
• · Registration of multiple images into a single view

The provided text is a 510(k) Summary for the ABLATE-IQ™ device, formerly known as Ablation Confirmation. It outlines the device's description, modifications, comparison to a predicate device, and the summary of non-clinical and/or clinical tests.

However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results as one might find in a full clinical or performance study report. Therefore, I can extract information related to the device's testing and general claims of performance, but specific quantitative acceptance criteria and detailed study parameters (like sample size for test sets, number of experts, adjudication methods, MRMC studies, or training set details) are not explicitly provided in this 510(k) summary.

Here's the information that can be extracted and a clear indication of what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan." However, the specific pre-determined acceptance criteria and quantitative reported device performance are not listed. The document mentions general validation of software functions.

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

• Sample Size for Test Set: Not provided. The document refers to "an established test plan" and "Design verification documents" but does not specify the number of cases or images used in the test set.
• Data Provenance: Not provided. There is no information about the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.

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

• MRMC Study: Not indicated. The document states the software "assists physicians," suggesting a human-in-the-loop scenario, but it does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Not explicitly detailed. The text mentions "ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software." This would imply standalone testing of the algorithm's functions (e.g., probe identification, ROI segmentation, image manipulation), but specific performance metrics for these standalone functions are not presented. The device is described as assisting physicians, implying it's not purely standalone in clinical use.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the description of the software's functions (e.g., identifying ablation targets, assessing probe placement, visualizing treatment zones post-ablation), the ground truth for features like probe identification and ROI/ablation zone segmentation would likely involve expert consensus on medical images (e.g., CT scans). However, the method for establishing this ground truth (e.g., expert consensus, pathology, outcome data) is not described.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not provided. This document is about verification and validation tests for substantial equivalence, not the development or training of an AI model.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through a comparison to a predicate device and a high-level summary of verification and validation testing. It confirms that the device passed its "pre-determined acceptance criteria" but does not disclose the specific criteria or the detailed methodology and results of the studies that would typically address the specific points you requested (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.). This level of detail is usually found in a more comprehensive clinical or performance study report, which is not part of this 510(k) summary.

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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.

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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 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.

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

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:

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.

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The NeuWave Medical Certus 140™ 2.45 GHz 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 Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a clinician.

The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. The User Interface can be set for either Ablation Mode. An optional footswitch can be connected to the system to control power delivery in Surgical Mode. Up to three (3) energy delivery accessories can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

A variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) are available for use with the Certus 140. All are comprised of a sharp trocar on the end of a cannula, a cable and a connector assembly.

Models Certus", and Certus " ablation probes are available in either 17- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Models Certus™ ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

The model Certus® ablation probe has a 13-gauge cannula and is available in a 25 cm length only. Certus® probes have a cable length of 1.4m.

Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The antenna of the Certus °° probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus Probes were developed to provide physicians with an additional ablation probe designed specifically for creating smaller ablation zones than the Certus" and Certus" probes. The Certus® probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Certus °° probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.

The Certus® probes length and gauge size result in a probe for use in laparoscopic applications.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

An accessory, a small plastic probe clip that can hold two 17-gauge probes and allow the user to easily hold both while performing planar coagulation, is available.

Ablation Confirmation software (K171022) is available as an option on the Certus 140. When this option is supplied, a second monitor is provided with the system which hosts the Ablation Confirmation user interface.

Here's a breakdown of the acceptance criteria and study information for the Certus 140 2.45 GHz Ablation System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance Table:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with specific performance metrics against pre-defined acceptance criteria. The "acceptance criteria" here are inferred from the demonstrated equivalence and the nature of the modifications. The performance is largely shown through the comparison and the conclusion of equivalence.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Nonclinical Acute In-Vivo (porcine) Studies: Sample size not explicitly stated in the summary, but it involved animal testing. Data provenance is implied to be internal (conducted by or for NeuWave Medical).
   • Real-World Evidence (RWE) Meta-analysis:
     • Sample Size: 1,924 patients across 18 studies.
     • Data Provenance: Retrospective, derived from published peer-reviewed literature. The studies included both randomized controlled trials (RCTs) and observational studies. Specific countries of origin are not detailed beyond "peer-reviewed articles," but such literature typically comes from various international sources.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the nonclinical in-vivo studies, the summary mentions "histological results were analyzed and evaluated." However, the number and qualifications of experts interpreting these results are not specified.
   • For the Real-World Evidence Meta-analysis, the "ground truth" was the reported clinical outcome of "technique efficacy (effectiveness) (defined as complete tumor ablation or complete response), measured at one week to three months post ablation" as reported in the individual studies included in the meta-analysis. The meta-analysis itself was conducted by "two independent reviewers" with "adjudication from a third reviewer" for discrepancies in study selection and data extraction. Their qualifications are not explicitly stated, but for a systematic review and meta-analysis, they would typically be researchers or statisticians with expertise in clinical evidence synthesis.

3. Adjudication method for the test set:

   • For the nonclinical in-vivo studies, no specific adjudication method is mentioned.
   • For the Real-World Evidence Meta-analysis, "Records were evaluated for eligibility by two independent reviewers and discrepancies were resolved either through consensus, or by adjudication from a third reviewer." This is a standard adjudication method for systematic reviews, often referred to as a "2+1" method for disagreement.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done in the context of AI assistance. This device is an ablation system, not an AI-powered diagnostic or assistive tool for human readers. The meta-analysis compared microwave ablation (MWA) to radiofrequency ablation (RFA), not human readers with or without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable. The Certus 140 is a medical device for tissue ablation, not a standalone algorithm. Its performance is directly tied to the physical ablation process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the nonclinical in-vivo studies, the ground truth appears to be histological results and ablation zone sizes, which would be assessed by trained histopathologists and researchers.
   • For the Real-World Evidence Meta-analysis, the primary ground truth was clinical outcomes data reported in the included studies, specifically "complete tumor ablation or complete response" as assessed by clinical follow-up imaging. This would typically be based on radiologic assessment (e.g., CT, MRI) often interpreted by radiologists, potentially with expert consensus within those original studies.

7. The sample size for the training set:

   • This information is not explicitly provided in the 510(k) summary. Given that the device is a physical ablation system (not an AI algorithm requiring a training set), this concept of a "training set" in the machine learning sense is not directly relevant for device performance. Training would refer to the development and refinement of the device's design and operating parameters, which would involve various benchtop and animal studies over time, but not a distinct "training set" like in AI.

8. How the ground truth for the training set was established:

   • As with the training set size, this question is not directly applicable to a physical ablation device in the way it is for an AI algorithm. The "ground truth" during device development (analogous to training) would typically involve engineering specifications, safety standards, and performance benchmarks derived from technical knowledge, predicate devices, and early-stage experimental data (benchtop, ex-vivo, in-vivo animal studies).

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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 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 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 provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets the acceptance criteria, as one might find for a clinical performance study of an AI/ML medical device. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance study data with specific metrics.

However, based on the available information, we can infer some aspects and highlight what is explicitly stated:

Overall Statement on Performance Data:
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." and "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices"."

This indicates that internal testing was conducted against a set of acceptance criteria, but the specific metrics, thresholds, and study design details (like sample size, ground truth establishment, etc.) are not included in this 510(k) summary. The focus is on functional testing and compliance with design controls rather than a clinical multi-reader, multi-case (MRMC) or standalone performance study.

Given this limitation, I will address the requested points by stating what is present, inferred, or explicitly missing from the provided text.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text. The document refers to "a test plan," but does not detail the number of cases or scans used in this testing.
• Data Provenance: Not specified. It's likely internal testing data, but the country of origin, or whether it was retrospective or prospective data, is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. The document describes software segmentation where "The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion." This suggests user interaction for defining targets/zones, but it doesn't describe a formal expert-driven ground truth establishment process for a test set.

4. Adjudication method for the test set

• This information is not provided. As a formal clinical performance study with expert readers is not detailed, an adjudication method would not be relevant in the context of the testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study is not described or referenced in this 510(k) summary. The device "assists physicians," but no study on the impact of this assistance on human reader performance (e.g., diagnostic accuracy, time saving) is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document implies that the software includes "segmentation algorithms" and "automatic identification of ablation probes." It states "Prior to an ablation procedure, physicians can use AC to semi-automatically segment..." and "AC then uses segmentation algorithms to construct a 2-D visualization..." and "AC can process the image and identify up to three ablation probes." While these algorithms likely underwent internal standalone testing for functionality and accuracy, the details of such standalone performance (e.g., specific metrics like Dice coefficient for segmentation, sensitivity/specificity for probe detection) are not provided in this summary. The summary focuses on the end-user workflow involving physician interaction ("semi-automatically segment," "physician can accept... or manually adjust").

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the internal "test plan" mentioned, the specific type of ground truth used to evaluate the software's performance (e.g., for segmentation accuracy or probe identification) is not explicitly stated. Given the device's function, anatomical landmarks and physician-defined regions (either through manual outlining or verification of semi-automatic results as described) would likely serve as a practical form of ground truth for functional verification. Pathology or outcomes data are generally not applicable for confirming image processing and segmentation accuracy.

8. The sample size for the training set

• This information is not provided. The document does not describe a machine learning training process with a distinct training set. It refers to "segmentation algorithms" but does not detail their development or the data used to train them.

9. How the ground truth for the training set was established

• This information is not provided, as details about a distinct training set and its ground truth establishment are absent from the summary.

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The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.

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

The system is designed for facility use and should only be used under the orders of a physician.

The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.

The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.

Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.

Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.

A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.

The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.

The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.

The provided document is a 510(k) summary for the NEUWAVE Flex Microwave Ablation System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI or algorithmic device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or cannot be extracted directly from this document.

However, the document does contain information about performance data and acceptance criteria related to its electrosurgical function.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The system passed all pre-determined acceptance criteria identified in the test plan." and "Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices."
While specific numerical acceptance criteria for ablation size are not explicitly stated in a table, the performance is reported in relation to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "Testing in ex-vivo liver, lung and kidney tissue" but does not specify the number of samples (e.g., how many livers, lungs, or kidneys were tested, or how many ablation procedures were performed on them).
• Data Provenance: The data is "ex-vivo" (meaning outside a living organism, likely in a lab setting) and was conducted for comparison to predicate devices and for data to be included in the Instructions for Use. The country of origin is not specified but the company is US-based (Madison, Wisconsin). The testing described is prospective in the sense that it was specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device for tissue ablation, not an AI/algorithmic device for diagnosis or image interpretation. The "ground truth" here relates to physical parameters and performance (e.g., ablation size, temperature, power output) which are measured directly, not established by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/algorithmic device involving subjective interpretation or expert consensus. Performance is measured against engineering specifications and comparison to a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for tissue ablation, not an AI/algorithmic device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Its "standalone" performance would be its ability to ablate tissue according to specifications, which was tested ex-vivo.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

• Direct physical measurements (e.g., ablation zone dimensions, temperature readings, power output).
• Compliance with pre-determined engineering and safety specifications.
• Substantial equivalence to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

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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 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 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 provided text describes the NeuWave Medical, Inc. Ablation Confirmation™ system and its 510(k) submission (K161285). However, it contains very limited direct information on acceptance criteria and the detailed study that proves the device meets specific acceptance criteria. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan" and "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"". It does not provide the specifics of these acceptance criteria or the study details.

Below is a summary of the information that is available in the provided text, and explicit statements about what information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available directly in the provided text. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan," but it does not list these criteria or report specific performance metrics against them.

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

Not available in the provided text. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective).

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

Not available in the provided text. The document does not mention the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication Method for the Test Set

Not available in the provided text. The document does not describe any adjudication method used for a test set.

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

Not available in the provided text. The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device assists physicians, but no comparative study is described.

6. Standalone (Algorithm Only) Performance

Partially available, but not with specific performance metrics. The document implies that the software performs several functions (segmentation, identification of probes, registration) semi-automatically or automatically. However, it does not provide standalone performance metrics (e.g., accuracy, sensitivity, specificity) for these functions. It states that "AC uses segmentation algorithms to construct a 2-D visualization" and "AC can process the image and identify up to three ablation probes."

7. Type of Ground Truth Used

Not explicitly stated for performance evaluation. For segmentation purposes, the text states that "The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion," implying that physician judgment (expert input) forms the ultimate "ground truth" for the intended use of identifying and adjusting target/ablation zones. However, for formal performance evaluation against acceptance criteria, the specific type of ground truth (e.g., pathology, outcomes data, consensus) is not detailed.

8. Sample Size for the Training Set

Not available in the provided text. The document does not mention any training set or its size.

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

Not available in the provided text. Given that the document does not mention a training set, the method for establishing its ground truth is also not provided.

Summary of what can be gleaned from the text regarding performance and validation:

The document indicates that:

• Ablation Confirmation™ "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 addition of the Tissue Contraction feature were analyzed and satisfactorily mitigated in the device design and labeling."

However, the specific details of these acceptance criteria, the performance metrics achieved, and the methodologies for the underlying studies (e.g., test set size, expert involvement, ground truth establishment) are not included in the provided 510(k) summary letter.

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The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings.

The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a clinician.

The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. The User Interface can be set for either Ablation Mode or Surgical Mode. An optional footswitch can be connected to the system to control power delivery in Surgical Mode. Up to three (3) energy delivery accessories can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

A variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) are available for use with the Certus 140. All are comprised of a sharp trocar on the end of a cannula, a handle, a cable and a connector assembly.

Models Certus", and Certus " ablation probes are available in either 17 gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Models Certus™ ablation probes are available only in 17 gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

The model Certus® ablation probe has a 13 gauge cannula and is available in a 25 cm length only. Certus56 probes have a cable length of 1.4m.

Certusurged surgical tool is hand-held and has a 6cm, 17 gauge cannula designed specifically for surgical coagulation (including Planar Coagulation) in open surgical settings. This device has a finger-activated power delivery mechanism and a cable length of 2.9m.

Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.

Additionally, the different percutaneous ablation probes have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.

Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue.

The antenna of the Certus® probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus® Probes were developed to provide physicians with an additional ablation probe designed specifically for ablating smaller lesions. The Certus® probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation. Certus® probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.

The Certus® probes length and gauge size result in a sturdy probe ideal for use in laparoscopic applications.

The CertuSurg67 surgical tool is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems. The CertuSurg®T surgical tool does not have the Tissu-Loc function.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

An accessory, a small plastic probe clip that can hold two 17 gauge probes and allow the user to easily hold both while performing planar coagulation, is available.

Ablation Confirmation software (K150313) is available as an option on the Certus 140. When this option is supplied, a second monitor is provided with the system which hosts the Ablation Confirmation user interface.

The provided text describes a medical device, the NeuWave Medical Certus 140 2.45 GHz Ablation System, and its accessories. It details its indications for use, device description, modifications, and performance data from a 510(k) summary. However, it does not contain explicit "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the format typically requested for AI/ML device evaluation.

The document discusses performance data in the context of substantial equivalence to predicate devices and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

Based on the provided text, here's what can be extracted and what is missing:

Missing Information:
The document does not provide:

• A table of explicit acceptance criteria with reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes used for a "test set" or data provenance for a diagnostic/AI study.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment specific to a diagnostic study.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance.
• Whether a standalone (algorithm only) performance study was done for AI.
• Details on the sample size for a "training set" or how ground truth for a "training set" was established, as these terms are relevant to AI/ML development, which is not the focus of this 510(k) summary for a microwave ablation system.

Information Extracted from the Document:

1. A table of acceptance criteria and the reported device performance:
   The document states: "The system passed all pre-determined acceptance criteria identified in the test plan." It also mentions "Ablation sizes for 15 gauge probe variants were deemed to be substantially equivalent to the predicate devices."
   However, specific numerical acceptance criteria and their corresponding reported performance values are not detailed in this summary. The criteria are general for compliance and functional equivalence.

   Acceptance Criteria (Implied)	Reported Device Performance
   Compliance with IEC 60601-1:2005 (Electrical Safety)	Passed applicable portions
   Compliance with IEC 60601-2-2:2006 (High Frequency Surgical Equipment)	Passed applicable portions
   Compliance with IEC 60601-2-6:1984 (Microwave Therapy Equipment)	Passed applicable portions
   Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility)	Passed applicable portions
   Compliance with EN ISO 11607-1:2009 (Sterilization Packaging)	Passed applicable portions
   Compliance with ISO 10993-1: 2009 (Biocompatibility)	Passed applicable portions
   Ablation size equivalence for 15 gauge probe variants	Deemed substantially equivalent to predicate devices (ex-vivo)
   System passed all pre-determined acceptance criteria	System passed all pre-determined acceptance criteria identified in the test plan.
   Verification and Validation Testing	Completed in accordance with company's Design Control process (21 CFR Part 820.30) and FDA Guidance on Software Contained in Medical Devices. Potential risks analyzed and mitigation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size (Test Set): Not specified in terms of patient/case count. Testing involved ex-vivo studies.
   • Data Provenance: Ex-vivo testing in bovine liver and lung and porcine kidney. This implies laboratory-controlled experiments rather than human clinical data from a specific country or retrospective/prospective human study.
   • The document also mentions "Ablation Confirmation software (K150313) is available as an option on the Certus 140." This suggests an AI/ML component might exist, but the performance data section describes testing for the ablation system itself, not specifically the "Ablation Confirmation software." If this software were to be evaluated as an AI/ML device, the detailed information requested would be critical. However, this 510(k) is not for the AI software, but rather for the overall ablation system and its hardware modifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable to the type of ex-vivo performance testing described. Ground truth was likely established through direct measurement of ablation zones in the ex-vivo tissue rather than expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No. This type of study is not mentioned as this document is for an ablation device, not an AI diagnostic/assessment tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The performance testing is for the ablation system's physical effects.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the ex-vivo studies, the ground truth would have been direct physical measurement of the ablation zone size in the tissue samples.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device approval focusing on a training set. The "design concepts, technologies and materials" were evaluated against predicate devices.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of what this document actually provides:
This document is a 510(k) summary for a microwave ablation system, focusing on its substantial equivalence to previously cleared predicate devices and its compliance with relevant medical device standards. The "performance data" section primarily discusses engineering and basic functional testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, and ex-vivo ablation size equivalence). It is not a document evaluating an AI/ML diagnostic or prognostic device, and thus many of the questions related to AI/ML study design are not addressed.

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