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IntelliBlate Microwave Ablation System:

The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures.

IntelliBlate Ximitry Probe Assembly:

The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue.

The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.

The IntelliBlate Microwave Ablation System is a software-controlled microwave therapy delivery system with graphical user interface and hardware to control and monitor the therapy delivered to the target tissues.

The system consists of a 2.45 GHz microwave generator (console) with an integrated peristaltic pump assembly for coolant fluid delivery, a coolant Fluid Mount and an optional mobile cart for the console. Accessories for the system include IntelliBlate Ximitry Probe Assembly - a sterile, single-use disposable microwave ablation assembly with ablation probes and a cassette for coolant fluid tubing (closed cooling circuit).

The provided text does not contain detailed acceptance criteria for the IntelliBlate Microwave Ablation System that would typically be found in a clinical study report or a more extensive submission. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing summaries.

However, based on the information provided, we can infer some general acceptance criteria related to safety and performance, and describe the studies conducted as reported in the "Performance Data" section.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations in detail for many of the requested points:

Implicit Acceptance Criteria and Reported Device Performance

Here's a breakdown of the other requested information based on the provided text. Please note that many of these details are not explicitly stated in the summary document.

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

• Test set sample size: Not explicitly stated for specific non-clinical tests. For the ex-vivo ablation performance study, it mentions testing in "porcine liver, kidney and muscle," but no specific numbers of samples or experimental runs are provided.
• Data provenance:
  • Ex-vivo ablation performance: Porcine tissues. Origin of the pigs not specified.
  • Acute animal testing: Porcine soft tissue models. Conducted in accordance with GLP Regulations (21 CFR Part 58) in the United States.

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 in the document. The studies mentioned (ex-vivo, animal GLP) would likely involve trained personnel or researchers, but their specific qualifications or role in establishing "ground truth" (e.g., assessing ablation zones) are not described. The document primarily focuses on engineering and animal model performance rather than human expert interpretation of results.

4. Adjudication method for the test set:

• This information is not provided in the document. Given the nature of the non-clinical and animal studies described, a formal adjudication method (like 2+1 or 3+1 often used for diagnostic AI) is very unlikely to have been applied. The evaluation would be based on direct measurements and observations by the researchers.

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 was not done. The IntelliBlate Microwave Ablation System is a hardware-based therapeutic device, not an AI diagnostic or assistance tool for human readers. Therefore, this type of study is irrelevant to this device.

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

• This device is a physical system for microwave ablation. The "software" mentioned in the document is for controlling the device's functions and user interface, not for standalone diagnostic or interpretive performance. Therefore, the concept of "standalone (algorithm only)" as it applies to AI diagnostics is not applicable here. The device's performance is inherently "standalone" in its therapeutic action, but this is not an algorithm acting independently of human control.

7. The type of ground truth used:

• For Ex-vivo Ablation Performance: The "ground truth" would be the actual measured ablation zone characteristics (e.g., volume, size, shape) in the porcine tissues, determined by direct observation or histological analysis post-ablation.
• For Acute Animal Testing: The "ground truth" would be the observed acute effects of ablation in porcine soft tissues, assessed through direct observation, physiological measurements, and potentially necropsy/histopathology.
• For Sterilization, Biocompatibility, Electrical Safety, etc.: The "ground truth" is adherence to specified standards and objective measurements (e.g., sterility assurance level, physical/chemical properties, electrical performance).

8. The sample size for the training set:

• This information is not applicable in the context of the studies described. The device is a microwave ablation system, and the testing described (functional, ex-vivo, animal, electrical, etc.) are verification and validation studies against pre-defined engineering and safety criteria, not training of a machine learning model.

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

• This information is not applicable for the reasons stated in point 8. There is no mention of a "training set" for a machine learning model. The "training" that occurs is in the development and refinement of the device's design and operational parameters based on engineering principles and iterative testing.

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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.

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The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.

The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.

The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.

The provided text describes a 510(k) premarket notification for a Microwave Ablation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or available from this 510(k) summary. This document primarily focuses on engineering and regulatory compliance rather than clinical performance metrics as might be found in a diagnostic AI device submission.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical outcome in the way an AI diagnostic device might. Instead, the "acceptance criteria" are implied by the conformance to various safety, performance, and software standards. The reported "performance" focuses on meeting these standards and demonstrating equivalence to a predicate device.

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

The document explicitly states: "No clinical study is included in this submission." This means there isn't a "test set" of patient data in the context of evaluating a diagnostic or AI-driven device's clinical performance. The testing mentioned (electrical safety, EMC, thermal effects) would involve laboratory setups and devices, not patient data.

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

Not applicable, as no clinical study or test set using patient data for ground truth establishment was conducted or reported.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring expert adjudication was conducted or reported.

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 device is a Microwave Ablation System, which is a therapeutic device, not a diagnostic device that would typically involve human readers or AI assistance for interpretation.

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

Not applicable. This device is a therapeutic system, not an algorithm or AI product. Its performance is related to its physical functions and safety, not an AI's standalone interpretation capability.

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

For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601 series) and FDA guidance documents. For instance, an electrical safety test's ground truth is whether the device does or does not meet the leakage current limits. This is based on objective measurements against engineering standards, not clinical ground truth like pathology.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set.

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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The AveCure BT Microwave Ablation System is intended for:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• · Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

The MedWaves' AveCure BT Microwave Ablation System is comprised of a microwave (915MHz ±13MHz) generator-controller, two antenna sizes mounted on the distal end of probes or catheters of various lengths, and flexibility, and a set of extension cables, one for microwave (MW) transmission and another for information communication between the antenna and the generator. The accessories (probes, catheters and extension-cable set) are supplied sterile and the generator-controller is the durable component of the system and is supplied non-sterile.

The MedWaves AveCure BT Microwave Ablation System is intended for palliative treatment of metastatic malignant lesions in a vertebral body and coagulation/ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct "criteria" with pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device. The performance metrics for this equivalence are the ablation range characteristics (volume, length, and width) and the treatment duration.

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

• Sample Size: The document does not explicitly state the numerical sample size used for the bench testing. It refers to "Data from experimental protocols" and "Bench testing in bone."
• Data Provenance: The study was a bench test conducted in-vitro (in bone). The country of origin of the data is not specified, but given the company's location in San Diego, California, it is presumably United States data. The study is implicitly prospective in its design, as it's a testing conducted to support a 510(k) submission.

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

This information is not provided in the document. Bench testing typically relies on objective measurements rather than expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth for ablation performance in a bench test is typically based on direct physical measurements, not human expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the physical ablation capabilities of the device in a bench setting, not on physician performance with or without AI assistance.

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

This is a physical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The study evaluates the device's physical performance in creating ablations.

7. The Type of Ground Truth Used

The ground truth used for the bench testing was based on direct physical measurements of the ablation dimensions (volume, length, and width) created by the device in bone. The document states "Volumes are estimates based on the calculation of volume for an ellipsoid," indicating a quantitative measurement approach to define the ablation zones.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.

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

As this is not an AI/ML algorithm, the concept of a training set and its ground truth is not applicable.

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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, 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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The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.

The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.

The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories.

The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles.

The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone.

The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure.

The system must be used with an irrigation baq of sterile water (not provided with the system).

The provided text describes the HEATfx Microwave Ablation System's 510(k) submission to the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/machine learning device.

The document focuses on the substantial equivalence of the HEATfx Microwave Ablation System to a predicate device (Emprint Ablation System) based on technological characteristics, performance data (system, mechanical, electrical, software, needle, thermal sensor, ex-vivo, in-vivo, biocompatibility, usability, packaging, sterility, pyrogenicity testing), and intended use.

Therefore, for the specific questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance), the provided text does not contain the necessary information.

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The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.

The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) of a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device as a Microwave Ablation System. Rather than specific performance metrics like sensitivity/specificity for a diagnostic device, the acceptance criteria for this therapeutic device are based on demonstrating equivalent technical characteristics, safety, and performance to a predicate device.

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

   • Test Set Sample Size: Not applicable. The submission states, "Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device." The testing primarily involved non-clinical bench and lab testing (e.g., electrical safety, EMC, performance, thermal effects, temperature monitoring, shelf life, package verification, sterilization validation, biocompatibility).
   • Data Provenance: Not applicable, as no clinical test set was used. The non-clinical testing data provenance is implied to be from the manufacturer's internal testing.

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

   • Not applicable, as no clinical test set was used that required expert ground truth establishment in this type of 510(k) submission.

4. Adjudication method for the test set:

   • Not applicable, as no clinical test set was used for adjudication.

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 device is a therapeutic microwave ablation system, not a diagnostic imaging AI device that would involve human readers or AI assistance for interpretation.

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

   • Not applicable in the context of diagnostic AI performance. The device is a physically operated medical system. However, software validation was performed, indicating the internal algorithms and software governing the device's operation were tested in a standalone manner (without human intervention in the algorithm's execution during ablation).

7. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" was established by adherence to recognized national and international standards (e.g., IEC 60601-1, IEC 60601-2-6, IEC 60601-1-2, ISO 11607-1, ISO 11135, ISO 10993), and engineering specifications for system performance, thermal effects, and temperature monitoring. These standards and specifications themselves represent a form of "ground truth" for acceptable device characteristics and safety.

8. The sample size for the training set:

   • Not applicable, as this device does not involve machine learning or AI models that require a training set in the conventional sense. The "training" here refers to the device's design, development, and adherence to established engineering principles and standards.

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

   • Not applicable, as no machine learning training set was used. The "ground truth" for the device's design and operational parameters was derived from existing medical device standards, predicate device characteristics, and established engineering and physiological principles related to microwave ablation.

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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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The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of non-resectable liver tumors. An optional Temperature sensor may be used to monitor tissue temperatures.

The MicroThermX® Microwave Ablation System (MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The procedure time and power parameters are operator selected via a touchscreen monitor. The system consists of a generator and pump attached to a mobile cart or tabletop stand, sterile disposable SynchroWave antennas with cooling circuit, and optional disposable TempSure temperature sensors. The closed cooling circuit consists of a bag of sterile isotonic saline (not supplied by Perseon), disposable, single-use cooling circuit tubing and connectors; and fluid pathway channels within each single-use antenna. A reusable pump circulates isotonic saline through the cooling circuit.

The provided text from the 510(k) submission for the MicroThermX Microwave Ablation System mainly focuses on regulatory compliance and substantial equivalence to a predicate device. It describes general performance testing against various IEC and ISO standards and internal requirements, but does not detail specific acceptance criteria for a clinical study comparing device performance to a predefined benchmark. The "Performance Testing" section primarily lists standards and does not offer explicit performance metrics or acceptance thresholds in the way a clinical study would for a specific diagnostic outcome (e.g., sensitivity, specificity).

However, it does mention a retrospective clinical study and animal study that supports the device's ability to treat non-resectable liver tumors.

Based on the provided document, here's what can be extracted and what information is missing regarding acceptance criteria and a study to prove they are met:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., target ablation size, success rate, sensitivity/specificity) from a clinical performance perspective in a measurable table format with clear thresholds.

It lists internal safety and performance requirements that were tested, but these are general categories rather than specific, quantifiable acceptance criteria.

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

• Test Set (Clinical Study):
  • Sample Size: 51 lesions in 31 patients.
  • Data Provenance: Retrospective clinical study. The country of origin is not specified.
• Test Set (Animal Study):
  • Sample Size: 18 ablations in liver and 22 ablations in lung.
  • Data Provenance: Porcine study. No country of origin is specified.

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

This information is not provided in the document. The document refers to a "retrospective clinical study" but does not detail how the success or outcome of the ablations in this study was adjudicated or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

This document is for a microwave ablation system, which is a therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.

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

This is not applicable as the device is a medical instrument for direct therapeutic intervention, not an algorithm.

7. The Type of Ground Truth Used

For the clinical study on non-resectable liver tumors, the ground truth regarding the "ability to treat" these tumors is implied by the clinical outcome observations. The specific method for establishing this ground truth (e.g., biopsy for complete necrosis, follow-up imaging showing absence of viable tumor, etc.) is not explicitly stated.

For the animal study, the ground truth for "ablation zone sizes" and "performing ablations in liver and lung" likely referred to direct pathological examination of the ablated tissue ex-vivo, but this is also not explicitly stated.

8. The Sample Size for the Training Set

The document describes performance testing for a physical device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device has undergone various engineering and pre-clinical tests but not "training" in the AI sense.

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

As the concept of a "training set" for an AI/ML algorithm is not applicable here, this point is also not relevant.

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