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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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The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) 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.

Electrosurgical probes are designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures. The device also has a smoke evacuation feature. The subject device has an angled shaft that fits through 10mm trocar cannulas and must be connected to a standard electrosurgical generator and a vacuum source in order to operate according to its intended use. The shaft can be rotated 360 degrees using a knob on the handpiece.

The probes are available in the following tip configurations:

• Spatula Tip
• L-Hook Tip
• Needle Tip

Here's a breakdown of the acceptance criteria and study information for the Epix Electrosurgical Probe with Smoke Evacuation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set used in the performance testing. However, it indicates:

• Sample Size: "Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures." This implies the use of a sufficient amount of tissue samples to conduct the comparison testing across various electrosurgical settings. Specific numbers of tissue samples are not provided.
• Data Provenance: The testing was "in vitro." The document does not specify a country of origin for the data beyond that it was performed in vitro. It is a retrospective study in the sense that it's a submission for a pre-market notification, relying on data collected for this purpose, not a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the performance testing. The comparison was based on objective measurements of thermal spread and aspiration flow rate against established predicate and reference device performance.

4. Adjudication Method for the Test Set

Not applicable. The testing was objective performance testing (thermal spread, aspiration flow rate) and comparison against predicate/reference devices, not a diagnostic or interpretive task requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes in-vitro performance testing comparing the new device to existing predicate and reference devices. It does not describe a MRMC comparative effectiveness study involving human readers or assessing improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The performance testing described is standalone in that it evaluates the physical device's performance characteristics (thermal spread, smoke aspiration) directly, without human interpretation in a diagnostic context. It's not an "algorithm" in the AI sense, but the device's functional performance was assessed on its own merits and in comparison to other devices.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was:

• Measured physical properties: Direct measurements of thermal spread in tissue and aspiration flow rate.
• Comparison to established predicate/reference performance: The performance of the predicate (Microline™ Electrosurgical Cautery Probes K981188) and reference devices (Applied Medical Suction/Irrigator K003443 and Applied Medical Epix Electrosurgical S/I Probes K132300) served as the benchmark for "truth." The claim is that the subject device performs similarly or comparably to these legally marketed devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a physical electrosurgical probe.

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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