(128 days)
The ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAGS is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
ISO-Gard® Mask Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Oxygen Delivery | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml without the use of N₂O | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings | The device met this criterion. |
| Scavenging | To evaluate the scavenging performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml with N₂O | N₂O levels must be lower than with a standard medium concentration oxygen mask | The device met this criterion. |
| ETCO₂ | To evaluate the ETCO₂ performance in simulated conditions | The traces/waveforms during testing must be distinct and generated consistently | The device met this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin. However, the tests are described as nonclinical performance testing and simulated conditions, suggesting laboratory-based studies rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The performance tests appear to be based on objective measurements against established technical standards for oxygen delivery, scavenging efficacy, and ETCO2 waveform characteristics, rather than expert judgment.
4. Adjudication Method for the Test Set
Since there is no mention of experts or human interpretation in establishing the ground truth for the test set, there is no adjudication method described (e.g., 2+1, 3+1, none). The tests rely on quantifiable measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. The device is a physical mask for gas scavenging and oxygen delivery, not an imaging or diagnostic AI tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The ISO-Gard® Mask is a medical device for gas delivery and scavenging, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant. The performance tests evaluate the physical functioning of the device.
7. Type of Ground Truth Used
The ground truth for the performance tests appears to be based on objective technical standards and measurements:
- For Oxygen Delivery: Comparison against "a standard medium concentration oxygen mask" and measurements of delivered oxygen percentage.
- For Scavenging: Measurement of N₂O levels compared against "a standard medium concentration oxygen mask."
- For ETCO₂: Evaluation of generated traces/waveforms for distinctness and consistency.
8. Sample Size for the Training Set
The document does not mention a training set. This is expected as the ISO-Gard® Mask is a physical medical device and not an AI or machine learning system that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set for this device.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).