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The Emprint™ ablation system is intended for use in percutaneous, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Emprint™ ablation system is not intended for use in cardiac procedures.

The Emprint™ ablation system overlapping technique is only intended for use in the liver.

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014.

The Emprint™ Ablation System is a microwave-based ablation system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W, or 150W generator to deliver power to a single microwave ablation antenna. The Emprint™ Ablation 100W Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation 150W Generator utilizes software and firmware, however both generators' settings are controlled in the same fashion. Emprint™ Ablation Generators provide for user setting of ablation time (0-10 minutes) and ablation power (5 to 150W). With an optional temperature probe, the ablation generators can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.

The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient.

The 510(k) Cleared Emprint™ Ablation System consists of the following components:

• Emprint™ Ablation Generator (2450 MHz) ●
• Emprint™ HP Ablation Generator (2450 MHz) .
• EmprintTM Percutaneous Antenna (sterile, single use) ●
• Emprint™ Ablation Reusable Cable ●
• Emprint™ Ablation Pump ●

The system also includes the following optional equipment/accessories:

• . Emprint™ Ablation Cart (with Isolation Transformer)
• Emprint™ HP Ablation Cart (with Isolation Transformer)
• Ablation Footswitch ●
• Remote Temperature Probe (sterile, single use) ●

The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

The provided text does not contain information about the acceptance criteria or a study that proves a device (specifically an AI/machine learning device) meets acceptance criteria, as the Emprint Ablation System is a microwave ablation system, not an AI/machine learning device. The 510(k) submission for the Emprint Ablation System describes updates to the instructions for use (IFU) to include "overlapping" and "ramp-up" ablation techniques, which were already observed in published literature and clinician practice.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them for an AI/machine learning device based on the given input, as the device in question is a traditional medical device and the submission focuses on updating its IFU, not on AI/ML performance.

The "Performance Data" section (9.9) explicitly states:

• "Clinical Studies in human subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.2)
• "Studies or testing in animal subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.3)
• Bench testing was conducted to generate zone charts for updated techniques (9.9.1). This is a standard ex-vivo engineering characterization, not a clinical study involving AI/ML methods or human readers.

None of the points outlined in the prompt (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are relevant or discussed in the provided document, as it pertains to a physical medical device and not an AI/ML system.

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