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The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

The Epix Electrosurgical Probe with Smoke Evacuation is a sterile, single-use monopolar instrument equipped with a smoke evacuation feature. The proposed device uses RF energy provided by a generator to electrosurgically cut and/or coagulate tissue during general laparoscopic procedures. The electrosurgical probes are available in three different tip geometries with probe lengths ranging between 20cm - 45cm. All models are constructed of the same materials and by similar manufacturing assembly processes.

This document from the FDA describes the substantial equivalence determination for the "Epix Electrosurgical Probe with Smoke Evacuation" (K171684) compared to a predicate device, the "Epix Electrosurgical Probes" (K132300).

The provided text does not contain the detailed acceptance criteria or the specific study results in the format requested. It states that certain performance tests were conducted and that the device "Met Acceptance Criteria" or was "Substantially Equivalent," but it does not specify what those criteria were (e.g., a numerical threshold or a specific characteristic being achieved) or the quantitative results of the tests.

Therefore, I cannot fulfill all parts of your request with the given information. However, I can extract the available information regarding performance data.

Here's what can be extracted based on the provided text:

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

Missing Information: The document does not specify the actual acceptance criteria (e.g., "electrical impedance within X ohms," "smoke evacuation rate of Y L/min") for each test, only that they were met or that the device was substantially equivalent.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. It can be inferred that the testing was conducted by Applied Medical Resources Corporation for this FDA submission, likely within the US, but this is not explicitly stated.
• Retrospective or Prospective: Not specified. These were likely laboratory-based performance and safety tests rather than clinical studies.

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)

• This information is not applicable and not provided. The performance tests described (Electrosurgical, Smoke Evacuation, Biocompatibility, Mechanical, Electrical Safety, EMC) are engineering and laboratory-based tests, not clinical evaluations requiring expert interpretation of results for ground truth establishment.

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

• This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of subjective findings. The tests performed are objective performance measurements.

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

• No MRMC comparative effectiveness study was done. The device is a physical electrosurgical probe, not an AI-assisted diagnostic tool.
• The document explicitly states: "No animal or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance."

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

• This question is not applicable as the device is a physical electrosurgical probe, not an algorithm or AI system.

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

• For the performance tests listed, the "ground truth" would be established by validated test methodologies and engineering specifications, rather than clinical ground truth types like pathology or expert consensus. For example, for electrical safety, the ground truth is adherence to IEC standards. For biocompatibility, it's compliance with ISO 10993 series.

8. The sample size for the training set

• This information is not applicable as the device is a physical electrosurgical probe, not a machine learning or AI device that requires a training set.

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

• This information is not applicable for the same reason as above.

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