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The CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures.

The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac procedures.

The CellFX® nsPFA™ Percutaneous Electrode System includes the CellFX Console, a family of CellFX nsPFA Percutaneous Electrodes (13G and 18G) and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.

This 510(k) supports the addition of the CellFX nsPFA Percutaneous Electrode, 18G, to the CellFX nsPFA Percutaneous Electrode family, which has smaller dimensions compared to that of the currently cleared CellFX nsPFA Percutaneous Electrode, 13G (K233705).

The provided document is a 510(k) summary for the CellFX® nsPFA™ Percutaneous Electrode System, specifically focusing on the addition of an 18G electrode. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the information you're looking for regarding acceptance criteria, specific device performance metrics in comparison to those criteria, and detailed study methodologies in terms of sample sizes, expert ground truth establishment, and comparative effectiveness studies (MRMC) would typically be found in direct PMA (Premarket Approval) submissions or more comprehensive clinical study reports, not usually within a 510(k) summary.

However, I can extract the information that is present in the document which relates to performance and design control testing that supports the claim of substantial equivalence.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria or detailed device performance metrics in the format you requested (e.g., sensitivity, specificity, accuracy against a numerical threshold). Instead, it states that various tests "met their respective acceptance criteria" or "passed," indicating qualitative compliance with established standards.

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

• Sample Size for Test Set: Not specified for any of the tests.
• Data Provenance: The pre-clinical animal study is described as an "in vivo GLP animal safety study." This implies a prospective study conducted under Good Laboratory Practice (GLP) guidelines, but does not specify the country of origin. Other tests (biocompatibility, electrical safety, bench, software) are typically performed in a laboratory setting, and their "provenance" would be the testing facility.

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

• For Biocompatibility, Electrical Safety, Bench, Software Testing: The concept of "experts establishing ground truth" as it applies to clinical data is not relevant for these types of engineering and laboratory tests. Compliance is based on meeting predefined technical standards and specifications.
• For Pre-Clinical Animal Safety and Performance Studies: The document doesn't specify the number or qualifications of experts involved in assessing the outcomes of the animal study. Conclusions would typically be drawn by veterinary pathologists or other scientific experts, but this detail is not provided.

4. Adjudication Method for the Test Set:

• For Biocompatibility, Electrical Safety, Bench, Software Testing: Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies. For these tests, the outcome is determined by adherence to a standard or a pass/fail criterion, not by expert consensus on ambiguous findings.
• For Pre-Clinical Animal Safety and Performance Studies: The document does not describe any specific adjudication method for the animal study results.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices to assess how human reader performance changes with or without AI assistance. The CellFX system is an electrosurgical device for tissue ablation, not a diagnostic imaging device, so an MRMC study is not relevant to its regulatory pathway as described here.

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

• The device is a physical electrosurgical system with associated software. The concept of "standalone performance" (algorithm only) as applicable to AI diagnostics (e.g., an algorithm interpreting images without human input) does not directly apply here. The software verification and validation testing assesses the software's performance within the integrated device system.

7. The Type of Ground Truth Used:

• Biocompatibility: Adherence to established biological safety standards (e.g., ISO 10993-1).
• Electrical Safety and EMC: Compliance with international electrical and electromagnetic compatibility standards (e.g., IEC 60601 series).
• Bench Testing: Performance against predefined engineering specifications and functional requirements.
• Software Verification and Validation Testing: Compliance with software development lifecycle processes and functional requirements as per FDA guidance.
• Pre-Clinical Animal Safety and Performance Studies: Biological effects observed in animal tissue (e.g., lesion formation, cellular changes, lack of adverse events) in a GLP study. This is considered an in vivo biological ground truth in an animal model.

8. The Sample Size for the Training Set:

• This document describes a device submission for an electrosurgical ablation system, not a machine learning or AI algorithm in the context of diagnostic image analysis where distinct training and test sets of patient data are typical.
• Therefore, the concept of a "training set" in the context of machine learning model development is not directly applicable or discussed in this 510(k) summary for this type of medical device. The software component refers to system control and safety functions, not an AI diagnostic algorithm.

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

• As explained in point 8, a "training set" for an AI algorithm is not referenced in this document.

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The CellFX® Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures. It is not intended for use in cardiac procedures.

The CellFX® Percutaneous Electrode System includes the CellFX Console, CellFX Percutaneous Electrode and Accessories: Percutaneous Adapter, pneumatic footswitch, and system software. The CellFX® Console is a proprietary energy-based platform for nanosecond Pulsed Field Ablation™ (nsPFA™) technology. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of highamplitude electrical energy to tissue via bipolar electrodes. The pulses create nanopores in lipid membranes, which disrupt the ability of the cell and internal organelles to maintain cellular homeostasis - ultimately leading to regulated cell death (e.g., apoptosis). The electrode is provided sterile, for single use only.

The provided text is an FDA 510(k) summary for the CellFX® Percutaneous Electrode System. It describes the device, its intended use, and the data presented to demonstrate its substantial equivalence to predicate devices. However, the document does not describe an AI/ML medical device.

Therefore, many of the requested points, such as "number of experts used to establish ground truth", "adjudication method", "MRMC comparative effectiveness study", "standalone algorithm performance", "sample size for training set", and "how ground truth for training set was established", are not applicable to this device's submission and are consequently not present in the provided text.

The device discussed is an electrosurgical cutting and coagulation device that uses nanosecond Pulsed Field Ablation (nsPFA) technology. Its performance is demonstrated through various traditional medical device validation methods, including biocompatibility testing, electrical safety and EMC testing, bench testing, software verification and validation, pre-clinical animal studies, and a human safety study.

Here's an attempt to answer the applicable points based on the provided text, while explicitly stating when information is not present or not relevant due to the device type:

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

The document does not present a formal table of "acceptance criteria" against specific "reported device performance" values in a quantitative manner for most tests. Instead, it states that tests "met their respective acceptance criteria" or "passed". For the human safety study, a quantitative result is provided.

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

• Test Set Sample Size:
  • Human Safety Study: Ten (10) subjects.
  • Pre-Clinical Animal Studies: "Two in vivo animal studies were conducted," but specific sample sizes for animals are not provided.
• Data Provenance:
  • The document implies the human safety study was conducted prospectively.
  • The geographical origin of the data (country) is not explicitly stated. Given the FDA submission, it's likely US-based or data accepted by the FDA.

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

• Not Applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this device's performance is objective measurement (e.g., ablation zone reduction as measured by ultrasound in the human study, or physical/electrical parameters in bench testing, or pathological examination in animal studies).

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

• Not Applicable. This concept is specifically relevant to human labeling or ground truth establishment in AI/ML performance studies. It is not relevant to the validation tests described for this 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

• No. An MRMC study was not done because this is not an AI/ML diagnostic or assistive device. The study performed was a human safety study of the device's direct clinical effect.

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

• Not Applicable. This is not an AI/ML algorithm. The device's performance is evaluated via its physical and biological effects.

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

• Human Safety Study: Outcomes data primarily, specifically "average of 95% reduction in ablation zones" (likely measured clinically, possibly via imaging like ultrasound, and "No serious adverse events were observed."
• Pre-Clinical Animal Studies: Likely involved pathological examination of ablated tissues for safety and effectiveness endpoints.
• Bench Testing: Engineering specifications and performance measurements.
• Biocompatibility/Electrical Safety: Standardized test methods specified by international standards (e.g., ISO, IEC).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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