(201 days)
The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a seff-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconutbased carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm.
PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.
Here's a breakdown of the acceptance criteria and study information for the CONMED PlumeSafe® X5™ Smoke Management System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance (Result) | Applicable Standards |
|---|---|---|
| Sound | Verify sound pressure and noise level characteristics per ISO Standards. | Pass |
| Initial Filter Efficiency | Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor per ISO Standards. This criteria is met if the reported filter efficiency is 99.9997% at 0.01 to 0.20 micron particle size. | Pass |
| Final Filter Efficiency | Verify filter configurations maintained the ULPA efficiency rating to remove 99.999% of the most penetrating particle sizes (MPPS) at set flow rate and concentration factor over a period per ISO Standards. | Pass |
| Continuous Use | Verify continuous operation and continuous surgical plume evacuation. | Pass |
| Intermittent Use | Verify the device runs intermittently over a specified amount of time without the motor stopping or overheating at a set airflow. | Pass |
| Motor Ramp-up | Verify the device can reach 90% of maximum suction within 2 seconds of activation when used with a surgical pencil. | Pass |
| Detection | Verify the device detects occlusion. | Pass |
| Reliability | Verify lifetime of motor at 350 hours. | Pass |
| Transportation | Verify the Filter and Console packaging configurations per ASTM D4169. | Pass |
| Flow | Verify airflow is maintained in Open, Pencil, and Laparoscopic modes. | Pass |
| Software verification and validation | Software testing completed per IEC 62304. | Pass |
| Electrical safety | Electrical Safety testing completed per IEC 60601-1 | Pass |
| Electromagnetic Compatibility (EMC and Immunity) | Electromagnetic Capability testing completed per IEC 60601-1-2. | Pass |
2. Sample size used for the test set and the data provenance:
- The document describes "benchtop testing" and "non-clinical performance testing." These are physical device tests, not tests on a clinical dataset.
- Therefore, there is no "test set" in the sense of a collection of patient data or images. The "samples" would be the physical devices, filters, and components themselves, tested under specific laboratory conditions.
- The provenance of data is not applicable in the context of clinical data, as this is solely benchtop testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. "Ground truth" in the context of expert review typically refers to a clinical diagnosis or labeling of medical images/data. Since this is benchtop device testing, there is no "ground truth" established by clinical experts for a test set. The acceptance criteria are based on engineering specifications and international standards, and the "ground truth" is measured by laboratory equipment and procedures.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of clinical data. For benchtop testing, results are typically objective measurements against predefined thresholds, not subjective interpretations requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a smoke management system, not an AI-powered diagnostic tool. The testing performed is related to the physical performance and safety of the device in filtering smoke and aerosols.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical smoke management system, not an algorithm or software that operates standalone for diagnostic or interpretive purposes. Its performance is measured independently of human interaction in terms of its ability to filter air, maintain flow, etc., but this is inherent to the device's function, not "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the benchtop tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, IEC, ASTM) and engineering specifications. The performance metrics (e.g., efficiency, flow rates, sound levels, motor lifetime) are objectively measured using calibrated laboratory equipment. There is no clinical "ground truth" in the form of expert consensus, pathology, or outcomes data for this type of device testing.
8. The sample size for the training set:
- This question is not applicable. The device is a hardware product, not a machine learning model; therefore, there is no "training set" in the context of artificial intelligence.
9. How the ground truth for the training set was established:
- This question is not applicable, as there is no training set for this device.
§ 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.