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The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparoscopic procedures for the removal of surgical smoke. Using a scroll pump and 4 stages of filtration, the Megadyne Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes are also clearly marked and easily accessible. The Megadyne smoke evacuator provides evacuation of smoke plume via a smoke evacuation device and tubing (e.g. E-Z Clear Smoke Evacuation Electrosurgical Pencil under K141587 on February 18, 2015) connected to the face of the Filter.

The Megadyne Smoke Evacuator has undergone non-clinical testing to demonstrate its safety and effectiveness. The acceptance criteria and reported device performance are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document provided does not specify the sample sizes used for each individual test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The tests listed are non-clinical, implying laboratory-based testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the non-clinical tests described, the concept of "ground truth" established by human experts, as typically seen in AI/ML performance studies for medical image analysis, does not directly apply. The acceptance criteria for these tests are based on established engineering standards (e.g., IEC standards) and design requirements. Therefore, the "ground truth" is defined by these objective measures rather than expert consensus on medical diagnoses.

4. Adjudication method for the test set:

Not applicable in the context of these non-clinical engineering and performance tests. The results are adjudicated against predefined, objective technical criteria.

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 is a medical device (smoke evacuator), not a diagnostic AI device that assists human readers.

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

The device described is a physical medical device (smoke evacuator) with embedded software for control and monitoring. The "software validation" test evaluates the performance of this embedded software, which would be considered a standalone assessment of the algorithm's functionality within the device.

7. The type of ground truth used:

• Electrical Safety, Electromagnetic Compatibility, Mechanical Safety, Thermal Safety: Ground truth is established by the requirements of international standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Software Validation: Ground truth is established by the functional design specifications and expected behavior of the software, with test cases designed to verify these.
• Flow Rate Testing, Filter Life Testing: Ground truth is established by internal design requirements and specifications for these performance metrics.
• Design Validation: Ground truth involves meeting user needs and avoiding use errors, likely assessed through usability testing and adherence to design specifications.
• Tissue Effects in Laparoscopic procedures: Ground truth would be based on scientific and medical understanding of minimal tissue effects during surgical procedures, likely observed and documented in a controlled setting.

8. The sample size for the training set:

Not applicable. This is a physical medical device, and the testing described is not for an AI/ML algorithm that requires a training set in the conventional sense. The "software validation" refers to verifying the embedded software, not training a machine learning model.

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

Not applicable, as there is no training set for an AI/ML model in this context.

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The Cut-Vac® Smoke Evacuation Electrosurgical is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.

The Precision Surgical Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil is a standard monopolar electrosurgical pencil with incorporated LED light, and suction ability for cautery smoke. It is a sterile single use device. It performs all standard functions of an electrosurgical pencil with separate buttons for Cutting and Coagulation. Cut-Vac connects to all standard electrosurgical generator units with a standard 3-prong plug. The Cut and Coag buttons, and light switch are on the top of the device. The proximal button to the tip/blade is yellow and controls Cutting. The blue button distal to the tip controls Coagulation. The green slider switch turns the LED light on and off. The LED light does not interfere with the function of the pencil and is encased in clear thermoplastic and does not contact liquid. The light allows the operator to visualize areas during surgeries or overcome shadows despite surgical Operating Room lights. It has removable separate small batteries that are located in the distal plug that attaches to the ESP, and thus are disposable in an environmentally safe method. The retractable blade allows the operator to better control smoke evacuation by shortening the effective blade length. Cut-Vac does not have irrigation capability. It has an 8.5 foot suction tube to attach to any suction with an additional 5 feet of electro-surgical cable from the end of the suction tube to attach to an ESP generator. The first 8.5 feet of the suction tube incorporates the electro-surgical cable to eliminate clutter on the surgical field. The electrical-surgical cable leaves the tubing through a sealed and molded closed port and terminates in a standard 3-prong electro-surgical plug. The remaining portion of the suction tubing terminates to a flexible connector that attaches to different suction canister ports. The integrated device enables the operator to cut, coagulate, evacuate smoke and illuminate the surgical site without the need for separate tools. The Cut-Vac® device must be used in conjunction with an electrosurgical generator and grounding pads in order to power up the device.

The document provided describes the Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil (K170721) and its substantial equivalence to a predicate device, the Zip-Pen Smoke Evacuation Electrosurgical Pencil (K141587). The information focuses on non-clinical performance data to demonstrate safety and effectiveness, as no human clinical trials were deemed necessary.

Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table detailing acceptance criteria with corresponding performance results for each test in a quantitative manner. Instead, it lists the types of tests performed and generally states that the device "passed all testing" or "performed equivalent to the predicate."

Based on the text, here's a reconstructed table:

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for electrical safety, number of tubing samples for leak tests). For smoke evacuation and thermal zone testing, it states "The Cut-Vac performed equivalent to the predicate," implying a comparative test, but the number of units or test iterations isn't provided. For Shelf Life Testing, it mentions "All units passed protocol acceptance criteria," but the number of "units" is not quantified.
• Data Provenance: The data is reported as non-clinical performance data generated by Precision Surgical, LLC. The origin (e.g., country) of the specific labs or facilities conducting these tests is not mentioned, but the sponsor is based in the USA (Las Vegas, Nevada). All data appears to be prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the document describes non-clinical performance and equivalence testing, not a study involving human interpretation of data for medical diagnosis or treatment. Therefore, no "ground truth" established by clinical experts for a test set is mentioned. The "ground truth" for these engineering and performance tests would be the established standards and specifications themselves.

4. Adjudication Method for the Test Set

This is not applicable as the document describes non-clinical performance and equivalence testing. Adjudication methods typically apply to human-interpreted studies, often in the context of medical imaging or clinical outcomes where expert consensus is needed to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This concept is not applicable to this device. The Cut-Vac® is an electrosurgical hand tool; it does not involve algorithms or AI. Its performance is inherent to its physical design, materials, and electrical properties. The "performance" discussed is related to its physical functions (cutting, coagulation, smoke evacuation, illumination) and compliance with safety standards.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly used is:

• Established engineering standards: e.g., ISO 10993-1, AAMI ANSI EC 60601-1, AAMI ANSI EC 60601-2-2, ASTM D5276-98.
• FDA Guidance Document requirements: for smoke evacuation and thermal zone testing.
• Predicate device performance: for comparative tests, demonstrating "equivalence" to a device already deemed safe and effective.

8. Sample Size for the Training Set

This information is not applicable. The device is an electrosurgical pencil and does not involve AI/ML requiring 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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