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PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

PROPENCIL Smoke Evacuation pencil consists of two types of disposable Smoke Evacuation monopolar pencils with finger controlled button switch or rocker switch for cutting and coagulation, and also suction cap, tube, hose are all included. All products are sterile, single-use, and disposable. The method of sterilization is Ethylene Oxide. The finger controlled switch is push button or rocker switch and the blade is an uncoated stainless steel electrode or ceramic coated non-stick blade.

PROPENCIL Smoke Evacuation pencil is designed to work with standard electrosurgical generators utilizing a 3-pin monopolar connection port and smoke evacuation units utilizing 8-to-22 hose connector. The tube is located near the electrode tip.

PROPENCIL Smoke Evacuation pencil is available with either a push button or a rocker switch, and some models include an optional holster. Most importantly the suction cap can be replaced with longer ones to extend the length of smoke pencil. The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.

This document is a 510(k) summary for the PROPENCIL™ Smoke Evacuation Pencil, an electrosurgical cutting and coagulation device with smoke evacuation capabilities. It compares the device to two predicate devices: LiNA Medical SafeAir (K120454) and Conmed, Inc. ClearVac (K982309).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical thresholds in a dedicated table format for all performance aspects. Instead, it states that the device "outperformed the predicate device" or "passed" certain tests. The "Substantial Equivalence Chart" (page 5) serves as a comparative performance assessment against predicate devices.

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

• Smoke Evacuation Performance Test: The document states "Bio Protech performed smoke evacuation bench comparison testing" but does not specify the sample size (e.g., number of devices tested, number of tests performed).
• Electrical Performance Test: For the worst-case EBE65N blade, it was "tested by INTERTEK." For other blades, "Bio Protech in-house" tested them. The sample size is not explicitly stated (e.g., how many units of each blade type were tested).
• Thermal Zone Damage Test: The document states "Bio Protech performed the thermal zone damage... by comparing visually assessed" against a predicate. The sample size of devices or assessments is not provided.
• Sterility and Shelf Life Testing: While accelerated aging tests and sterility validation were conducted, the sample size for these tests is not specified.

Data Provenance:

• The tests were conducted by Bio Protech, Inc. (the manufacturer), and for certain electrical safety tests and the worst-case electrical performance test, by INTERTEK (a third-party testing organization).
• The data is retrospective in the sense that it's generated from lab tests of the manufactured device.
• The manufacturer's location is the Republic of Korea (Donghwa Medical Instrument Complex).

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

This information is not provided in the document. The tests described are primarily bench tests and comparisons against predicate devices, not expert human evaluations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable for the reported bench and performance tests, as these did not involve human interpretation or subjective assessment that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The studies mentioned are bench tests and comparisons, not studies involving human readers or clinical scenarios.

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

No, this device is a physical electrosurgical pencil, not an algorithm. This question is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for the performance comparisons seems to be based on:

• Performance of predicate devices: The device performance was compared against established predicate devices (LiNA Medical SafeAir and Conmed ClearVac) in terms of smoke evacuation efficiency, electrical performance, and thermal zone damage.
• Compliance with international standards: For sterility (ISO 10993-7, EN ISO 11607-1) and electrical safety (IEC 60601-1, IEC 60601-2-2), the "ground truth" is adherence to these recognized industry standards.
• Visual assessment: For thermal zone damage, it was "visually assessed."

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

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