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The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

The NanoKnife System is a device used for tissue ablation using irreversible electroporation (IRE), a method of focal ablation which uses high voltage electrical pulses to change the permeability of the cell membrane leading to cell death. During the procedure, electrical pulses between probe pairs produce an electric field which induces electroporation of cells within the targeted abation area. The NanoKnife System with six outputs is currently indicated for the surgical ablation of soft tissue by the United States Food and Drug Administration (FDA).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: A total of 121 subjects were enrolled and subsequently treated with the NanoKnife System.
• Data Provenance: The study was a prospective, nonrandomized pivotal study. The document does not explicitly state the country of origin of the data, but the submission is to the U.S. FDA, implying the study was conducted to support a U.S. market application.

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

• This information is not provided in the given text. The ground truth for effectiveness was based on biopsy results, which are pathological findings, not subjective expert readings of images.

4. Adjudication Method for the Test Set:

• This information is not applicable as the primary effectiveness endpoint was based on objective biopsy results ("negative in-field biopsy"), not subjective assessments requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This study evaluated the performance of the NanoKnife system itself for tissue ablation, not how human readers' performance improved with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not applicable. The NanoKnife System is a medical device for surgical ablation, not an AI algorithm. The study assessed the device's clinical effectiveness directly.

7. The Type of Ground Truth Used:

• The primary effectiveness ground truth was based on pathology, specifically the result of an "in-field biopsy at 12 months" (negative or positive). Safety ground truth was based on the incidence and grading of adverse events (AEs) using CTCAE v5.0.

8. The Sample Size for the Training Set:

• Not applicable. The NanoKnife System is a physical medical device, not an AI model that requires a "training set" in the machine learning sense. The "PRESERVE" study was a clinical trial to evaluate the device's performance.

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

• Not applicable. As stated above, this is a physical medical device, not an AI model. Therefore, there is no "training set" or ground truth establishment in this context.

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The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.

The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable. With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

The provided text is an FDA 510(k) premarket notification for a medical device, the "Electroporation System (N3000)". It outlines the device description, indications for use, comparison to a predicate device, and various tests performed to demonstrate substantial equivalence.

However, the document does not contain information regarding acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance).

The document primarily focuses on:

• Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series.
• Biocompatibility Testing: Compliance with ISO 10993-1.
• Sterilization & Shelf Life: Compliance with ISO 11135 and ISO 11607.
• Software Validation: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Functions.
• Animal Testing: An in-vivo animal study on porcine models to compare ablation volume and ECG trigger mode, and potential thermal ablation effect, between the subject and predicate devices.

The "Animal testing" section states: "The results show that the safety and efficacy of the tested articles are similar to those of the control articles." This is the closest the document comes to a performance claim, but it's not quantitative or related to AI/ML acceptance criteria.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about the specific types of studies listed (MRMC, standalone algorithm performance, AI assistance effect size, etc.) because these details are not present in the given document.

The document clearly states: "Clinical studies were not required to demonstrate the substantial equivalence of the Electroporation System and the predicated device." This further indicates that no human clinical performance study, often where metrics like sensitivity/specificity and MRMC studies would be conducted for AI/ML devices, was performed or presented in this 510(k).

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The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.

The INUMI™ Flex Needle (subject device) is an endoscopically compatible soft tissue ablation device that is used as part of the 510(k)-cleared Aliya™ System (K212871). The subject device has a 160 cm working length, and is compatible with endoscope working channels with a minimum of 2.0 mm diameter.

This is a 510(k) premarket notification for the INUMI™ Flex Needle, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria typically associated with AI/ML device performance. Therefore, many of the requested details related to AI/ML device studies (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details) are not applicable or not provided in this regulatory submission.

However, based on the provided text, I can extract information related to the performance testing conducted for this medical device to demonstrate its safety and effectiveness.

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

The document doesn't provide a direct table of specific numerical acceptance criteria. Instead, it describes various performance tests conducted and generally states that the device "demonstrated compliance," "conforms to predefined specifications," or "supports a determination of substantial equivalence."

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

• Biocompatibility: Not specified as a numerical sample size. Testing was performed on "patient-contacting components."
• Sterilization: Not specified (often involves multiple runs/batches to reach SAL 10^-6).
• Shelf-Life/Package Validation: Not specified (typically involves multiple packages/units).
• Electrical Safety, EMC, Capacitive Coupling, Mechanical/Electrical Performance: Not specified (typically involves a representative number of devices or components).
• Ex Vivo Characterization of Thermal Effects on Tissue: Tested in "three types of ex-vivo porcine tissue - liver, kidney, and muscle." The number of samples per tissue type is not specified. Data Provenance: Ex-vivo porcine tissue.
• Comparative Ablation Performance (Animal): A "Porcine model" was utilized. The number of animals or specific lesions is not stated. Data Provenance: Porcine (animal model).
• Endoscopic Performance (Animal): A "chronic porcine GLP study" was conducted. The number of animals is not stated. Data Provenance: Porcine (animal model), GLP study (implying prospective, controlled experimental design).

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 described are primarily engineering, chemical, and animal studies, not interpretative studies requiring human expert consensus for ground truth.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or challenging diagnoses, which is not the primary focus of the performance tests outlined here for a physical medical 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:

This is not applicable. The device is an electrosurgical needle, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the various performance tests is established through:

• Compliance with validated standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11135), electrical safety (IEC 60601 series), package integrity (ASTM/ISTA standards).
• Predefined mechanical and electrical specifications: For mechanical and electrical performance.
• Direct measurement and observation: For thermal effects on tissue (temperature-time history), tissue destruction, navigation, access, and ablation endpoints in animal models.
• Comparison to predicate device: For performance aspects where substantial equivalence is being demonstrated.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device.

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The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.

The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues.
The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items:

• Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator
• Canady Helios™ Cold Plasma Ablators
• Foot Pedal
• Trolley Cart
  The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.

This document, K240297, is a 510(k) Premarket Notification for the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System. It demonstrates substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the information requested about acceptance criteria, study details, ground truth establishment, sample sizes, and expert adjudication as pertains to AI/ML device performance is not applicable to this submission.

The document focuses on the safety and effectiveness of the electrosurgical ablation system itself, comparing it to an existing predicate device based on its intended use, technological characteristics, and performance testing against recognized standards.

Here's a breakdown of what is available in the document regarding the device's performance and acceptance, interpreted in a general sense rather than specifically for AI/ML:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance; rather, it lists various tests conducted and generally states that the device "Met criteria." This is common for non-AI medical devices where performance is typically validated against engineering specifications and applicable standards, rather than statistical thresholds for diagnostic accuracy.

The document also notes in the Substantial Equivalence table:

• Performance: "Shown to ablate soft tissue at specified parameters." (For both subject and predicate device).

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

This information is not applicable as the document describes a traditional medical device (electrosurgical ablation system) and its performance validation, not an AI/ML-powered device requiring a test set for algorithmic performance evaluation. The "tests" mentioned are likely bench testing, in-vitro experiments, or potentially animal studies (though not specified), designed to verify physical and electrical properties, sterility, and basic function. Data provenance as typically understood for AI (e.g., country of origin of patient data, retrospective/prospective) is irrelevant here.

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

Not applicable. There is no "ground truth" in the AI/ML sense (e.g., clinical labels for images) established by experts for this type of device. Performance is assessed against engineering specifications, safety standards, and the ability to perform its stated function (ablation).

4. Adjudication Method for the Test Set:

Not applicable. No adjudication methods are described as there is no human interpretation of data for algorithmic ground truth establishment.

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

Not applicable. This type of study is relevant for AI/ML diagnostic or assistive technologies where human reader performance is a key metric. This is a therapeutic electrosurgical device.

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

Not applicable. As this is not an AI/ML device, the concept of a standalone algorithm performance test is not relevant.

7. Type of Ground Truth Used:

Not applicable in the AI/ML sense. For this device, "ground truth" refers to established engineering principles, safety standards (e.g., electrical safety, electromagnetic compatibility), and the physical outcome of the ablation process (e.g., tissue ablation effectiveness, thermal effect), verified through laboratory testing against specifications.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

Not applicable. Similar to point 8, there is no training set or associated ground truth for this type of medical device submission.

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The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.

The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.

The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.

The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.

The Irreversible Electroporation Ablation Generator has three working modes:

• A Mode 1: Monopolar steep pulse mode;
• A Mode 2: Bipolar steep pulse mode;
• A Mode 3: Needle Track Coagulation.

Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.

The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.

Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.

This document is a 510(k) summary for a medical device and does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically presented for AI/ML performance. The information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

However, based on the information provided, we can infer some "acceptance criteria" through the comparative non-clinical studies.

Here's an analysis based on your request, adapting to the provided document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative performance acceptance criteria in a dedicated table for the device's efficacy. Instead, it describes non-clinical tests designed to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing the subject device's effects to those of the predicate and reference devices in specific animal and ex-vivo models.

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

• Test Set Sample Size:
  • Ex-vivo tissue testing: Swine muscle, liver, and kidney tissue. The specific number of tissue samples or experiments is not provided.
  • In-vivo animal testing: Swine. The specific number of animals used in the subject device group and predicate device group is not provided.
• Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer being based in China. The studies are non-clinical (ex-vivo and in-vivo animal), not human clinical.

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 are non-clinical. The assessment of "ablation effect and ablation zones" or "blood parameters" would typically be performed by trained lab personnel, veterinarians, or pathologists, but specific details on their qualifications or number are not available in this regulatory summary.

4. Adjudication Method for the Test Set

This information is not provided. Given that these are non-clinical studies evaluating physical effects and physiological parameters, typical clinical adjudication methods (like 2+1 or 3+1 consensus) are not directly applicable. The "ground truth" is derived from direct measurements and observations in the experimental setup.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes a medical device, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

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

Not applicable. This device is an Irreversible Electroporation Ablation Generator and Probe, which is a physical medical device used for surgical ablation. It is not an AI algorithm. While it has embedded software, its performance is assessed as part of the overall device system, not as a standalone AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical studies mentioned:

• Ex-vivo and in-vivo tests: The "ground truth" for evaluating ablation effect and ablation zones, blood parameters, etc., would be based on direct measurement, observation, and analysis by laboratory techniques (e.g., macroscopic and microscopic examination of tissue, blood tests). It's a form of objective measurement/pathology from the experimental models.

8. The Sample Size for the Training Set

Not Applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The "development" of the device would involve engineering design, prototyping, and iterative testing, not machine learning model training.

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

Not Applicable. As explained above, there is no AI/ML training set for this device.

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The Aliya System is indicated for the surgical ablation of soft tissue.

The Aliva System is designed to ablate soft tissue through the delivery of pulsed electric fields (PEF) energy to target tissue. The high frequency, short duration energy delivered to the target tissue to induce programmed cell death (apoptosis) while maintaining the cellular matrix.

The Aliya System consists of an Aliya Generator, an Aliya Ablation Device and a cardiac monitor.

Generator: The Aliya Generator is a transportable non-sterile electrical device compatible for use in the operating room environment. It consists of hardware, software, a display touch screen user interface, a power supply cord and a foot switch. It features controls to initiate and stop treatment as well as indicators to monitor the treatment and provide alerts to the user.

The Aliya Generator creates high frequency short duration energy, which is delivered to the target tissue via the Aliya Ablation Device. The Generator interfaces with the commercially available Ivy Biomedical Model 7600 cardiac monitor (Cardiac Monitor), which is provided with the Aliya System and is used in accordance with its cleared indications. The Cardiac Monitor uses a 4-lead configuration, which detects the R-wave of the electrocardiogram (ECG) signal and sends a trigger signal to the Generator for precise synchronization of energy output to the patient. This ensures reliable energy delivery synchronization with the patient's cardiac cycle thereby reducing risk of cardiac rhythm disturbances.

The Generator software includes an algorithm that interprets trigger signals from the Cardiac Monitor. The algorithm will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits.

Aliya Ablation Device: The Aliya Ablation Device is a monopolar electrosurgical instrument comprising the Aliya Needle and the Aliya Electrode. Both the needle and electrode are designed for sterile, single use. The Aliya Needle consists of a 19 gauge, 20cm needle with a 1 cm exposed tip and a nested stylet (which is removed once the Aliya Electrode is in position). The Aliya Electrode consists of a 21 cm probe that connects with the needle, a 3-meter cable, and a plug that connects with the Aliya Generator. When connected to the Aliya Generator, the Aliya Ablation Device delivers PEF energy to the target zone at the distal 1 cm of the needle.

The provided document does not describe the acceptance criteria or a study that proves a device meets specific performance criteria related to AI or algorithm performance (as might be expected for an AI-enabled medical device). Instead, this document is a 510(k) summary for a medical device called the "Aliya™ System," which is an electrosurgical cutting and coagulation device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for establishing substantial equivalence to a predicate device, primarily focusing on safety and performance through engineering and biological testing, rather than an AI model's diagnostic or predictive performance.

Therefore, the requested information about AI-related acceptance criteria, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for an AI model cannot be extracted from this document.

The document focuses on the following types of testing and their "acceptance criteria" (implied as 'Pass' for all tests):

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

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

• Animal Study: The document mentions "six healthy porcine" for an in vivo animal study. This study was conducted to evaluate "safety and performance under clinically relevant operating conditions." The tissues treated were "liver, kidney, and skeletal muscle." The provenance would be experimental animal data, likely prospective as it was a study conducted specifically for this submission. The origin (country/institution) is not specified.
• Ex-vivo Tissue Ablation Performance Testing: Conducted using "liver, kidney, and muscle tissue." The "sample size" in terms of number of tissue samples is not specified. Provenance is experimental, ex-vivo.

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

• For the animal study: "three different study physicians" were involved in applying treatment. Their qualifications are not specified beyond being "study physicians." The document does not describe experts establishing ground truth in the context of diagnostic interpretation, but rather physicians performing procedures in an experimental setting.
• For engineering and biological tests, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with standards. No explicit "experts" (e.g., radiologists) are mentioned for establishing ground truth in a diagnostic sense.

4. Adjudication method for the test set:

• Not applicable in the context of this type of device testing. The testing described is performance, safety, and compatibility testing, not diagnostic or interpretive tasks requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The device is not an imaging analysis or AI assistance tool for human readers. It's a surgical ablation system.

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

• Not applicable in the context of an AI algorithm. The device does have internal software (algorithm) in the Generator that "interprets trigger signals from the Cardiac Monitor" and "will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits." This is a functional safety algorithm, not an AI for diagnosis. The "standalone" performance for this is covered under "System and Software Verification" and "Hardware Verification" which passed.

7. The type of ground truth used:

• For the animal study: Visual inspection, "baseline and post procedure CB-CT (Cone Beam Computer Tomography) scanning procedure" to visualize treatment sites, and animal survival up to 28 days for endpoint evaluation. This is a form of in vivo outcome data and imaging-based assessment.
• For ex-vivo testing: Implied physical assessment of ablation zones in tissue.
• For other tests (electromechanical, EMC, etc.): Engineering specifications, compliance with recognized standards (listed in the document), and established test methodologies.

8. The sample size for the training set:

• Not applicable. This device is not an AI learning model that requires a "training set" in the machine learning sense. The software in the device is a rule-based algorithm, not a trainable AI model.

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

• Not applicable, as there is no "training set" for an AI model. For the functional software, its "ground truth" (i.e., correct behavior) would be defined by its design specifications and validated through software verification processes.

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The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.

The NanoKnife System is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue. Included for use with the system are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

The provided FDA 510(k) summary for the Angiodynamics NanoKnife System (K183385) does not detail acceptance criteria or a comparative effectiveness study involving human readers with and without AI assistance, as the device is an electrosurgical device for soft tissue ablation, not an AI/imaging diagnostic device.

However, based on the information provided regarding performance testing of the device, I will extract and present the relevant information to address the prompt's requests as much as possible, focusing on the device's technical and safety performance rather than AI-specific criteria.

Here's a breakdown of the acceptance criteria (implied by compliance with standards and performance data) and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/imaging diagnostic device, performance is not measured in terms of metrics like sensitivity, specificity, or AUC. Instead, performance is demonstrated through adherence to safety and performance standards, and comparison to a predicate device's operational characteristics.

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

The document explicitly mentions an "animal study" was conducted for "System Testing" to characterize the device's performance over the expected range of operating conditions, particularly for evaluating "Thermal Effects on Tissue."

• Test Set Description: Animal study data.
• Sample Size: The exact number of animals or ablation procedures performed in the animal study is not specified in the provided text.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific institution), but animal studies are typically conducted under controlled laboratory conditions. The document does not specify whether it was retrospective or prospective, but animal studies for device characterization are generally prospective.

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

• Not Applicable. This device is an electrosurgical ablation system, not an AI diagnostic tool requiring expert interpretation of images for ground truth establishment. The "ground truth" for its performance relates to physical parameters like ablation volume, which would be measured directly in the animal study.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is a physical device performance test (ablation volume), not a diagnostic interpretation where adjudication of human judgments would be necessary.

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 not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant for this type of device.

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

• Not Applicable. This is a hardware electrosurgical device with control software. Its "standalone performance" is its ability to deliver the specified electrical parameters and achieve the intended ablation effect, as demonstrated in the animal study. There is no independent "algorithm" in the sense of an AI model whose performance is measured in isolation.

7. The Type of Ground Truth Used

• Direct Measurement/Experimental Observation: For the performance study (animal study), the "ground truth" was likely the directly measured ablation volume or tissue effect observed in the animal models, rather than expert consensus, pathology in the diagnostic sense, or long-term outcomes data as might be used for diagnostic tools. The P-value for ablation volume comparison supports this.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/machine learning system that requires a "training set" of data in the conventional sense. Its "training" or development involves engineering design, component selection, software development, and iterative testing/validation.

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

• Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant. The "ground truth" for the device's design and functioning is based on established engineering principles, electrical safety standards, and physiological understanding of tissue ablation.

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The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.

The NanoKnife System is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue. Included for use with the system are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, electrical current is delivered between pairs of probes in a series of pulses. The waveform of the current is adjustable as determined by clinician-chosen parameters. These parameters include volts/cm, pulse length, number of pulses to be delivered between electrode pairs, distance between probes, and the timing mode (90PPM, 240PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled current is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

Please note that the provided document is a 510(k) summary for a medical device which aims to demonstrate substantial equivalence to a predicate device. It is not a clinical study report or a publication detailing a clinical trial with acceptance criteria and statistical analysis of a new device's performance against a pre-defined set of criteria in a clinical setting.

Therefore, many of the requested categories, such as "Sample size used for the test set," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance," are not directly applicable or explicitly stated in this type of regulatory submission. The document focuses on demonstrating that modifications to an existing device do not alter its safety or effectiveness.

However, I will extract and present the information that is available and relevant to your request based on the provided text.

Acceptance Criteria and Device Performance (Based on Technical and Safety Requirements for Substantial Equivalence)

The document primarily focuses on verifying that the modified NanoKnife System continues to meet its specified performance and safety requirements, which are implicitly the "acceptance criteria" for substantial equivalence to the predicate device. The performance data section describes the types of tests conducted to ensure this.

Detailed Information as Available from the Document:

1. A table of acceptance criteria and the reported device performance:
   (See table above) These are implicitly the acceptance criteria for determining substantial equivalence based on the technical changes. The "reported device performance" is that the device "meets all the specified performance specifications."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document describes engineering and in-vitro testing of the modified device, not a clinical study with a "test set" in the sense of patient data. Therefore, information on sample size for a test set (e.g., number of patients/cases), data provenance (country of origin), or retrospective/prospective nature is not applicable or provided. The tests mentioned are laboratory-based.

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):
   This information is not applicable as the document describes technical/engineering testing, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable as the document does not describe a clinical study requiring adjudication of expert-derived ground truth.

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:
   This information is not applicable. The device (NanoKnife System) is an electrosurgical device for soft tissue ablation, not an AI-powered diagnostic or interpretive tool that assists human readers. No MRMC study is mentioned or relevant to this type of device and submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The NanoKnife System is a medical device (hardware and software) that performs a physical intervention (ablation). It is not an algorithm designed for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the engineering and performance testing described:

   • Functional/Performance Testing: The "ground truth" is adherence to predefined engineering specifications, design requirements, and regulatory standards (e.g., voltage accuracy, pulse duration, EMC compliance).
   • Biological Impact Modeling: The "ground truth" for the modeling was based on established physics and biological models (Pennes bioheat model, finite element analysis) using "clinically-relevant input parameters."

8. The sample size for the training set:
   This information is not applicable. The NanoKnife System is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for such a device would be its design, development, and testing against engineering specifications.

9. How the ground truth for the training set was established:
   This information is not applicable for the reasons stated in point 8.

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The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue.

The NanoKnife System transmits low energy direct current (LEDC) energy from the Generator to Electrode Probes placed in a target area for the surgical ablation of soft tissue. The NanoKnife System includes multiple components. The first component of the system is the Generator. The Generator operates outside of the sterile field and consists of an LCD Display, Console. Power Unit and Power Cord situated on a wheeled trolley and a Double Footswitch/Foot Pedal. The last component of the NanoKnife System is the sterile, single-use, disposable Electrode Probe. The NanoKnife System has the same device configuration as the Oncobionic System with 6 Probe Output (K080202) with minor design modifications to the hardware componentry and software. The range of parameters, pulse amplitude and pulse length, have been narrowed, a third option to the unsynchronized pulse per minute has been added, and touch screen capability in the GUI have been provided to the end user. The fundamental operating principle and design of the NanoKnife System is identical to the Oncobionics predicate devices.

The provided text contains information about the NanoKnife® System's 510(k) premarket notification. However, it does not include details about acceptance criteria, specific device performance metrics, or a study designed to prove the device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than reporting on clinical performance against specific metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states:

• Substantial Equivalence: "The NanoKnife System is substantially equivalent to its predecessors... The NanoKnife System is a modified version of these predicate devices..." (Page 1, Section "PREDICATE DEVICE")
• Testing: "All necessary bench testing was conducted on the NanoKnife System to support a determination of substantial equivalence to the predicate device. The bench testing verifies that the NanoKnife System meets all the specified performance specifications and thus, is substantially equivalent to the predicate devices." (Page 1, Section "TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION")

This indicates that the submission relied on bench testing to show that the new device's technical specifications met those of the predicate devices, thereby establishing substantial equivalence. It does not provide data from a study measuring the device's clinical performance against pre-defined acceptance criteria relevant to its intended use (surgical ablation of soft tissue).

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The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

The Oncobionic System with 6 probe output is identical in design specification to the Oncobionic System cleared under K060054. The only change to the Oncobionic System with 6 probe output is the addition of 4 output ports to allow for the connection of up to six electrodes to the Generator. This design addition has been added for convenience to the use. The user can connect multiple pairs of probes thus to removing the need to connect and disconnect pairs of electrodes when treating multiple treatment sites.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided documents do not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. This 510(k) submission is for a modification to an existing device, specifically adding more output ports for convenience. The primary "study" mentioned is a benchtop test to confirm the new configuration still meets the output specifications of the original device, not a performance study in a clinical setting.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Acceptance Criteria and Device Performance

Study Details (Based on available information)

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

• Sample Size: Not specified in terms of units or cases. The study was a "Bench Top Test of Generator Output," implying measurement of the device itself rather than patient data.
• Data Provenance: Benchtop testing, not clinical data from a specific country or population.

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

• Not applicable. This was a technical benchtop test, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or human interpretation was involved.

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 MRMC or human-in-the-loop study was done. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's technical output, which was confirmed through bench testing.

7. The type of ground truth used:

• The "ground truth" for this technical assessment was the established output specifications of the predicate Oncobionic System (K060054).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set was used.

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