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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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