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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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