(144 days)
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
| Title of Test | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety Testing | Evaluate Electrical Safety | Fulfill the requirements of IEC 60601-1: 2012 reprint as applicable | Passed |
| Electromagnetic Compatibility | Evaluate Electromagnetic compatibility | Fulfill the requirements of 60601-1-2 4th edition as applicable | Passed |
| Software Validation | Evaluate device software | All test cases shall pass or deviations explained as to why it is acceptable | Passed |
| Flow Rate Testing | Evaluate flow rate against design requirement | The flow rates at each FLOW setting in LAP mode of the MESE1 units are within the defined tolerances. | Passed |
| Filter life Testing | Evaluate filter life against design requirement | The filter life testing shall be successful if time-based filter requirement is met | Passed |
| Design Validation | Objective evidence that the subject device meets the needs of the user | There shall be no pattern of use error, close calls or difficulty using the device | Passed |
| Tissue Effects in Laparoscopic procedures | Tissue effects of unintended high vacuum | Effects on tissue shall be minimal | Passed |
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.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.