(175 days)
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates the surgical smoke produced during cauterization. The main purpose of smoke evacuation systems is to remove surgical smoke plume as close as possible to the surgical site. The component of the system ensuring that this is achieved is a diathermy pencil with integrated smoke evacuation function or a click-on tubing set connected to a surgical smoke evacuator. SafeAir Smoke Evacuator compact is designed for use in the hospital/clinic environment. It is built around a vacuum pump with a replaceable filter at the entry point. A specially designed pump control is centrally placed in the machine. The SafeAir Smoke Evacuator compact is designed with a pump with different activation functions; manual activation on the front panel, footswitch activation through diathermy pencil with smoke evacuation tubing. Synchronization is possible with most of the electrosurgical units.
The provided document is a 510(k) summary for the SafeAir Smoke Evacuator compact, a device designed to remove and filter smoke generated during electrosurgical and laser procedures. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance using AI or clinical studies. Therefore, much of the requested information regarding AI-specific studies, expert involvement, and ground truth establishment is not present in this regulatory submission.
However, I can extract information related to the device's functional performance and comparisons to the predicate device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated as separate acceptance criteria in the sense of predefined thresholds for clinical performance. Instead, the document demonstrates substantial equivalence by comparing technological characteristics and performance test results with the predicate device (Visiclear Smoke Evacuation System - K131402). The "acceptance" is implied by the similarity in performance to the predicate and compliance with relevant safety standards.
Here's a table based on the provided "Technological Characteristic Comparison Table" (Table 3), interpreted as performance demonstration against the predicate. The "Acceptance Criteria" column is derived from the predicate device's reported performance or general safety standards.
| Variable | Acceptance Criteria (Based on Predicate/Standards) | Reported Device Performance (SafeAir Smoke Evacuator compact) | Comparison |
|---|---|---|---|
| Filtration efficiency | 99.999% efficiency at 0.1 to 0.2 micron particle size (ULPA-grade) | 99.999% with efficiency at 0.1 microns particle size (ULPA filter) | Same |
| Filter Life | 35 hours (Predicate) | 5 hours | Use life of the filter is established with performance testing and is consistent with intended claims. (Different but justified) |
| Filter life indicator | Shut down (Predicate) | Indicator light | When the indicator light is on, the user is instructed to change the filter. (Different but justified) |
| Electrical safety | Compliant with IEC 60601-1 and IEC 60601-1-2 | Tested and compliant with IEC 60601-1 and IEC 60601-1-2 | Same |
| Mechanical safety | Compliant with IEC 60601-1 | Tested and compliant with IEC 60601-1 | Same |
| Chemical safety | Neutral pH, non-patient contact | Neutral pH, non-patient contact | Same |
| Thermal safety | Operation does not result in harmful temperatures per IEC 60601-1 | Operation of the device does not result in harmful temperatures tested and compliant per IEC 60601-1 | Same |
| Radiation safety | Non-radioactive | Non-radioactive | Same |
| Maximum flow rate (claimed) | 839 l/min (Predicate) | 110 l/min | Flow rate for the subject device is demonstrated to effectively entrain surgical smoke. (Different but justified as effective) |
| Maximum flow rate (suction pencil)* | 93.2 l/min (Predicate) | 97.1 l/min | Similar |
| Maximum flow rate (suction tube)* | 62.2 l/min (Predicate) | 66.2 l/min | Similar |
| Minimum flow rate (suction pencil)* | 43.1 l/min (Predicate) | 41.2 l/min | Similar |
| Minimum flow rate (suction tube)* | 25.9 l/min (Predicate) | 26.0 l/min | Similar |
*All values obtained from simulated use testing.
2. Sample size used for the test set and the data provenance
The document mentions "simulated use testing" for flow rates. It does not specify a "test set" in terms of a dataset for AI evaluation, nor does it provide a sample size (number of tests or cases) for these simulated use tests. There is no information on data provenance (country of origin, retrospective/prospective) as this is a physical device performance test rather than an AI data study.
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. The performance testing described is engineering/validation testing against physical parameters and standards, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described, as the testing involves objective measurements against engineering specifications and comparison with a predicate device, not subjective expert reviews.
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 MRMC study was conducted or is relevant to this device. This is a smoke evacuator, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI algorithm performance. No such study was conducted as the device is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with recognized electrical, mechanical, thermal, and chemical safety standards (e.g., IEC 60601-1, IEC 60601-1-2) and demonstrated functional performance (e.g., filtration efficiency, flow rates) that is "as safe, as effective and performs as well as or better than" the predicate device. This is primarily engineering and performance verification, not clinical ground truth.
8. The sample size for the training set
Not applicable. This device does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. No AI training set.
§ 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.