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The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.

The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil.

The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume.

The provided text does not contain information about the acceptance criteria and study that proves the device meets them. The document is a 510(k) premarket notification from the FDA for a medical device called the "Neptune E-SEP™ Smoke Evacuation Pencil."

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K153679). This means the manufacturer is asserting that the new device is as safe and effective as the predicate, based on its similarities and the results of non-clinical performance testing.

Here's what can be inferred or stated from the document regarding the device's performance and testing:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed as a table of acceptance criteria and corresponding performance metrics. The document broadly states under "Performance Data (Non-Clinical Tests)": "The results of the performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the electrodes for use with the Neptune E-SEP pencil is sufficient for their intended use and support a determination of substantial equivalence to the predicate device."

  • Evaluation Areas: The performance testing covered:
    • Electrical Safety Testing
    • Functional / Performance Testing
    • Thermal spread testing
    • Biocompatibility testing
    • Sterilization and packaging testing
  • Results: "Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence."

• Sample Size Used for the Test Set and Data Provenance: This information is not provided in the document. The document refers to "performance testing" but does not specify sample sizes for these tests or the data provenance.

• Number of Experts Used to Establish Ground Truth and Qualifications: This information is not applicable as the document describes non-clinical performance testing, not a study involving ground truth established by medical experts.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." This indicates that comparative effectiveness studies with human readers were not performed.

• Standalone (Algorithm Only) Performance Study: Not applicable, as this is a physical medical device (an electrosurgical pencil), not an AI algorithm.

• Type of Ground Truth Used: Not applicable. The performance testing described (electrical safety, functional, thermal spread, biocompatibility, sterilization) relies on engineering specifications, standards, and laboratory evaluations rather than a medical "ground truth."

• Sample Size for the Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

• How Ground Truth for the Training Set Was Established: Not applicable.

In summary, the document provides evidence for substantial equivalence through non-clinical performance testing against established standards and comparison to a predicate device, rather than a study with acceptance criteria and clinical performance metrics as might be found for a novel diagnostic or therapeutic device.

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