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The MedWaves Microwave Coagulation/Ablation System is intended for general surgical use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.

The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes are 15-cm in length, 14gauge in diameter, configured into large or small handle. The large handle configuration is the original blue elongated egg-shaped plastic, and the small handle is white plastic handle with 90-degree cable exit (both are made of the same ASB plastic).

The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications, the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coagulation/ablation performance.

The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: overtemperature, over-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes variables and posts the ablation parameters and progress for the user on an LCD screen.

MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high-powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.

The provided text describes the MedWaves Microwave Coagulation/Ablation System. I will extract the requested information based on the content of this document.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" in the context of clinical data or image analysis. The performance claims are based on compliance with established engineering and safety standards, as well as mechanical and in vitro testing of the probes. There is no mention of patient data, clinical studies, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The provided summary is for a medical device (microwave coagulation/ablation system) and focuses on engineering, safety, and performance standards. There is no mention of experts establishing ground truth for a test set in the context of diagnostic accuracy or clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no test set requiring expert adjudication for ground truth (e.g., in an image analysis context) is described.

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

Not applicable. This device is a surgical ablation system, not a diagnostic imaging or AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of the provided information.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The device, a microwave coagulation/ablation system, operates based on physical principles for tissue ablation. Its "performance" refers to its ability to generate microwave energy and ablate tissue as intended, not an algorithmic output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical and in vitro testing of the catheter/probes, the "ground truth" was likely established through established scientific methods, physical measurements, and comparison to the "published performance of currently marketed products" and "intended use" specifications. For regulatory compliance, the ground truth is adherence to the specified international and national standards (e.g., ISO, EN, AAMI).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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