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The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Pulse Biosciences® CellFX® System is a proprietary platform technology. The CellFX System consists of the CellFX Console, CellFX Handpiece, CellFX Treatment Tips, and CellFX Software. The CellFX System delivers nanosecond duration electrical pulses that disrupt the function of cells leading to cell death, while sparing non-cellular tissue. The CellFX System delivers a series of timed, nanosecond electrical pulses (referred to as a "Cycle") to ablate and resurface tissue areas in dermatologic conditions.

The CellFX Console is capable of delivering short electric pulses at amplitudes up to 15 kV and pulse widths up to 700 ns. The electrical energy pulses are applied directly to targeted tissue using sterile Treatment Tips with stainless steel microneedles. The treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.

The provided text describes the CellFX® System, an electrosurgical cutting and coagulation device, and its acceptance criteria for FDA clearance. The information focuses on safety and performance, drawing comparisons to a predicate device, Fractora by Invasix Ltd.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For Biocompatibility Testing:

For Electrical Safety and Electromagnetic Compatibility (EMC):

For Software Verification and Validation Testing:

For Animal Study (Safety):

For Animal Study (Performance):

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

The primary testing described for effectiveness and safety is an Animal Study.

• Sample Size: 15 Yucatan pigs.
• Data Provenance: The study was conducted as a GLP (Good Laboratory Practice) animal safety study. While the geographical origin isn't specified, GLP studies are typically conducted in controlled laboratory environments. It is a prospective study since animals underwent treatments specifically for the study.

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

The document does not explicitly state the number or qualifications of experts for establishing ground truth within the animal study. However, the evaluation included:

• Gross evaluation
• Histopathological analysis
• Clinical pathology
• In-life physical examinations

These types of evaluations would typically be performed by qualified veterinary pathologists, clinicians, and support staff, but specific numbers and qualifications are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The evaluations for the animal study (gross, histopathological, clinical pathology, physical exams) suggest a comprehensive assessment, likely involving consensus among the relevant scientific and medical professionals involved in the study, but a formal adjudication process is not detailed.

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

No, an MRMC comparative effectiveness study involving human readers or interpretation of results is not mentioned or described in this document. The study described is an animal study validating device safety and performance.

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

This device is not an AI algorithm. It's a physical electrosurgical system. Therefore, the concept of "standalone (algorithm only)" is not applicable here. The performance described is that of the physical device in an animal model.

7. The Type of Ground Truth Used

For the animal study, the ground truth was established through a combination of:

• Histopathology: Microscopic examination of tissue samples.
• Clinical Pathology: Analysis of blood or other body fluids.
• Gross Evaluation: Macroscopic observation of tissues and organs.
• In-life Physical Examinations: Direct clinical assessment of the animals.
• Survival Data: Absence of procedure-related complications.

This constitutes a comprehensive set of biological and pathological observations.

8. The Sample Size for the Training Set

The document does not describe a training set. This is a premarket notification for a physical medical device, not an AI/ML algorithm that typically undergoes a training phase with a dataset.

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

As there is no training set described for this device, information on how its ground truth was established is not applicable.

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