Search Results

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).

Ask a specific question about this device