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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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Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

HS AMICA devices family is an integrated system for thermoablation of tissues through controlled emission of non-ionizing electromagnetic radiations in the microwave and radiofrequency ranges. Especially the HS AMICA family consists of 3 devices and relative accessories emitting: 1. Only microwaves (MW) or 2. Only radiofrequency waves (RF) or 3. Either microwaves or radiofrequency waves (not simultaneously). The three devices emit the specific wavelength through their applicators (probes) that are inserted into the human body and deliver electromagnetic energy through their emitting tip, causing the thermoablation. Briefly, the HS AMICA devices family consists of two main components: 1) the generator; 2} the applicator (probe). The generator of the electromagnetic energy is available in the following variants, depending on the specific electromagnetic emission: 1. AMICA GEN AGN-H. This variant is characterized by both the MW and RF modules that must be selected by the physician. When the MW function is selected, the RF emission is disabled and viceversa and thus the modules operate in mutually exclusive fashion 2. AMICA GEN AGN. This variant has only the MW module. 3. AMICA GEN AGN-R This variant has only the RF module. In all cases, the AMICA GEN is provided with an electronic control unit (EC), for data exchange with the patient applied parts, the interpretation of user's commands through front panel controls or external peripherals (such as the footswitch for remote energy start/stop), the continuous update of the machine indicators, and the control of the energy generation modules MW and/or RF. The applicator (probe) is disposable and consists of the following variants, to be used for the MW or RF thermoablation: 1. AMICA PROBE. This variant is a microwave coaxial antenna of asymmetric dipole type allowing the emission of the MW energy 2. RF AMICA-PROBE. This variant is used for radiofrequency energy delivery through monopolar interstitial electrode.

The provided text is a 510(k) Summary for the HS AMICA devices family, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices (K083157 and K053290) through a comparison of technological characteristics and performance data.

However, the document does not contain the level of detail typically required to fully answer a request for acceptance criteria and a study proving a software/AI-based device meets those criteria, especially regarding clinical study design elements like sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies for AI performance.

The "Performance Data" section discusses:

• Electrical safety
• Electromagnetic compatibility
• Software verification and validation (developed and validated according to FDA guidance and IEC 62304:2006, but no specific performance criteria or results are given beyond "compliance")
• Biocompatibility
• Performance test-bench: This is the closest to device performance, focusing on physical ablation size on ex-vivo tissues for both microwave and radiofrequency components, compared to predicate devices.

Therefore, many parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as the document describes a traditional electrosurgical device, not an AI/software-driven diagnostic or assistive system with the types of performance metrics you've outlined.

However, I can extract the information that is present and indicate where information is missing based on the context of the document.

Acceptance Criteria and Device Performance (Based on available information for a physical device, not AI)

Detailed Study Information (Based on a typical AI/Software Device Request vs. Provided Document)

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

   • Provided: For the "Performance test-bench" (ablation size), the data provenance is "ex-vivo tissues (muscle, liver, lung and kidney)". No specific number or type of "samples" (e.g., number of tissue blocks, number of ablation procedures) is given, nor is the origin country. This is not a clinical test set in the context of AI.
   • Missing for AI: No information on test set size (e.g., number of images, cases) or data provenance (e.g., retrospective/prospective, number of sites/patients, country of origin) for AI performance evaluation.

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

   • Provided: Not applicable. The "ground truth" for the performance test was the physical measurement of ablation size on ex-vivo tissues. This was a physical measurement, not an expert-derived truth.
   • Missing for AI: No information on expert involvement or their qualifications.

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

   • Provided: Not applicable. Ground truth was direct measurement for the physical performance test.
   • Missing for AI: No information.

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:

   • Provided: No. This study was not an MRMC comparative effectiveness study involving human readers. It was a comparative performance test of a physical device against its predicates on ex-vivo tissue concerning ablation size and general safety/EMC standards.
   • Missing for AI: No information.

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

   • Provided: Not applicable. This device is an electrosurgical unit, not an algorithm performing a standalone diagnostic or assistive function on its own data inputs (like images). The "software verification and validation" mentioned refers to the embedded software that controls the hardware, not an AI algorithm for autonomous decision-making or analysis.
   • Missing for AI: No information.

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

   • Provided: For the "Performance test-bench," the ground truth was the physical measurement of the size (depth, width, length) of the ablation zone created on ex-vivo tissues.
   • Missing for AI: Not applicable in the context of this device.

7. The sample size for the training set:

   • Provided: Not applicable. This device is not an AI model that undergoes a "training set" in the machine learning sense. The "training" relates to the design and testing process of the engineering.
   • Missing for AI: No information.

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

   • Provided: Not applicable. See point 7.
   • Missing for AI: No information.

In summary, the provided document from the FDA is a 510(k) summary for a traditional electrosurgical device, not an AI-powered diagnostic or assistive medical device. As such, it details engineering and safety performance (electrical safety, EMC, biocompatibility, and physical ablation size) relative to predicate devices, rather than the complex clinical validation and ground truth establishment methods typical for AI/ML-based software products.

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The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The Cool-tip™ Switching Controller is an adjunct device for the Cool-tip™ RF Ablation Generator, designed to facilitate the simultaneous activation of multiple electrodes. It routes power from the generator, allowing the physician to ablate lesions with one single electrode, one cluster electrode, or simultaneously with two or three pre-placed electrodes. The controller sequentially switches power between electrodes until the selected procedure time is reached. It also automates the manual function of cauterization during electrode removal.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity). Instead, the acceptance is based on the device demonstrating safety and efficacy comparable to a predicate device. The key performance aspect is the ability of the switching controller to produce similar therapeutic effects (lesions) as the predicate device when using various electrode configurations.

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

The study involved preclinical testing on bovine liver, both ex vivo (outside the body) and in vivo (in a living organism). The document does not specify a precise numerical sample size (e.g., number of livers, number of ablation procedures, or number of electrodes tested).

However, the data provenance is clearly stated as bovine liver, indicating an animal model. The study is described as "preclinical testing," implying it's a prospective study designed to compare the new device to the predicate.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The comparison of lesion characteristics likely involved direct measurement and observation rather than expert consensus on a diagnostic outcome.

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

No, an MRMC comparative effectiveness study was not conducted. This device is an accessory to an existing RF ablation system and its performance demonstration focuses on the equivalence of the generated lesions, not on diagnostic accuracy involving human readers.

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

This question is not applicable in the context of this device. The Cool-tip™ Switching Controller is a hardware accessory that automates power delivery for RF ablation electrodes. It does not involve algorithms for interpretation or generate diagnostic outputs that would have a "standalone performance" in the typical sense of AI/software. Its performance is intrinsically tied to its interaction with the RF generator and electrodes.

7. The Type of Ground Truth Used

The ground truth for this study was based on the characteristics of the lesions produced by the RF ablation. The statement "lesions produced... are comparable" implies a physical assessment of ablation zones (e.g., size, shape, completeness) as the reference for comparison. This would likely involve macroscopic and/or microscopic examination of the ablated tissue.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning device, so the concept of a training set as used in AI development is not applicable here.

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

As there is no training set for this hardware device, this question is not applicable.

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