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The SERF Ablation System is intended for the coagulation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
The SERF Ablation System is intended for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

The SERF Ablation System and SERF Ablation Needle provide heat to unwanted tissue targeted for ablation and thermal necrosis. The SERF System has these main components:

1. SERF Ablation System console which houses the RF generators, fluid pump, and system user interface.
2. System user interface, an alphanumeric display for menus and messages and a control panel which displays the set-point of each parameter of the therapy.
3. SERF Ablation Needle, a single-use, sterile device intended to penetrate tissue to locate the point of therapy initiation based on visual guidance. The SERF Needle is electrically connected to the system and delivers RF energy and warm saline to the tissue through perforations in the shaft near the needle tip.
4. A sterile single-use syringe for use with the SERF system is commercially available.
5. Return electrode pads and cables for use with the SERF System are commercially available, The SERF system is a monopolar electrosurgical device.

The provided text is a 510(k) summary for the Thermedical SERF Ablation System, which is a medical device for tissue ablation. It outlines the device's intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to predicate devices.

However, the 510(k) summary does not contain the level of detail requested for acceptance criteria and study design elements typical for an AI/ML medical device submission. Specifically, it is lacking:

• A table of specific acceptance criteria with corresponding performance metrics. The document states general categories of testing (e.g., "Needle performance characterization and function tests of electrical impedance and fluid leak") but not quantitative targets or results that would be used as acceptance criteria.
• Information regarding a test set sample size, provenance, or details of a ground truth establishment process (experts, adjudication, exact type of ground truth). The studies mentioned are primarily engineering validation (electrical safety, EMC, software validation) and preclinical (animal studies) and a human study for return electrode pad thermal rise, not diagnostic performance studies that would involve a test set with ground truth.
• Any mention of a multi-reader multi-case (MRMC) study or standalone algorithm performance. This is because the device is a physical RF ablation system, not an AI/ML algorithm that interprets medical images or data.
• Details about training sets or how ground truth for a training set would be established. Again, this is not an AI/ML device.

Given the nature of the device (a physical radiofrequency ablation system) and the regulatory pathway chosen (510(k) for substantial equivalence to existing predicate devices), the "acceptance criteria" discussed in the document are primarily related to product performance specifications, safety standards, and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

Therefore, I cannot directly answer your prompt using the provided text as it pertains to an AI/ML device. The document describes a traditional medical device submission, focusing on engineering validation and animal/limited human studies for safety and performance of the physical system, not an AI/ML model's diagnostic or predictive capabilities.

If you are looking for an example of a 510(k) summary for a medical device that includes AI/ML components, the information provided here for the Thermedical SERF Ablation System would be insufficient.

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