Search Results

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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. Up to 3 microwave ablation probes 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.

Probes are provided sterile and are intended for single patient use only. Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 1.4 meter cable and a connector assembly.

Models Certus", Certus", and Certus" have 17 gauge cannula and are available in 15 cm and 20 cm lengths.

Model Certus®, has a 13 gauge cannula and is available in a 25 cm length only.

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

Additionally, different 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.

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 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.

The provided 510(k) summary for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories does not describe a study involving an AI/Machine Learning algorithm.

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.

The summary describes a medical device for soft tissue ablation and its modifications, focusing on substantial equivalence to predicate devices and compliance with international standards. The performance data mentioned refers to ex-vivo studies conducted to compare the new device with a predicate device, which would typically involve physical measurements of ablation zones rather than AI-driven evaluations.

Ask a specific question about this device

The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are intended 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 intended for use in cardiac procedures.

NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:

• Pregnant patients potential risks to patient and/or fetus have not been established .
• Patients with implantable pacemakers or other electronic implants. Implanted . electronic devices may be adversely affected by microwave power
• . Use on the central nervous system

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. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. The maximum selectable power for the system is dependent on the probe type used. For Certus", Certus " and Certus " probes, the maximum power is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. When Certus® probes are used, the maximum power is 65W regardless of the number of probes connected. An intermediate iunction box or Power Distribution Module (PDM) reduces system set up complexity.

Probes are provided sterile and are intended for single patient use only. Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 1.4 meter cable and a connector assembly.

Models Certus™, Certus*, and Certus " have 17 gauge cannula and are available in 15 cm and 20 cm lengths.

Model Certus®, has a 13 gauge cannula and is available in a 25 cm length only.

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

The ablation probe assembly contains 4 main sections: a handle, a cannula, a radiating section and a faceted tip for insertion. The probes have a triaxial antenna design is created from a coaxial monopole antenna passed through a hollow needle. The needle creates the triaxial structure and its tip is positioned approximately ¼ of a wavelength proximal to the monopole base. This positioning improves antenna efficiency and reduces fields flowing back on the coaxial outer conductor. In turn, more energy is deposited in the tissue.

Additionally, different 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.

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 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.

The provided text describes a 510(k) summary for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories. However, it does not contain the specific details about "acceptance criteria" and "device performance" in the format of a clinical study with statistical outcomes.

The "Performance Data" section mentions that the device "has been verified through rigorous testing that, in part, supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above." It then immediately states, "Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device."

This indicates that some performance testing was done, but the document does not provide any quantitative acceptance criteria, reported device performance metrics, sample sizes (for test or training sets), ground truth establishment details, or information about expert involvement (number, qualifications, adjudication) associated with these studies. It also does not mention any multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore,Based on the provided text, I cannot complete the table or answer most of your questions as the requested information is not present. The document focuses on regulatory compliance, device description, and intended use rather than detailed clinical study results and acceptance criteria.

Ask a specific question about this device