(338 days)
The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.
The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/N₂ is controlled to maintain a steady concentration of NO/N₂ within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/Nz flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern.
The device consists of a cart, a gas manifold connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply, a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.
The provided document describes the ViaNOx Delivery System, a nitric oxide administration device. It includes a 510(k) summary for FDA clearance, which compares the device to a predicate device (INOvent® Delivery System) and outlines non-clinical performance data.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table against the predicate device, INOvent, for various characteristics. For "Measurement Accuracy," the ViaNOx Delivery System states its specific performance. This can be considered the acceptance criteria based on its comparison to the predicate.
| Characteristic | Acceptance Criteria (ViaNOx Delivery System™) | Reported Device Performance (ViaNOx Delivery System™) |
|---|---|---|
| Measurement Accuracy | No explicitly stated quantitative acceptance criteria based on a threshold of improvement or non-inferiority compared to a standard. The device's performance values are provided for comparison to the predicate, implying they meet an acceptable level for market clearance. |
(Implicit acceptance criteria: Performance comparable to or better than the predicate device for safe and effective use.) | NO: +/- ${0.5 ppm + 20%}$ of the reading at NO values ≤ 20 ppm AND
+/- ${0.5 ppm + 10%}$ of the reading at NO values > 20 ppm
NO2: +/- ${20%}$ of the reading OR 0.5 ppm whichever is greater
O2: +/- 3% absolute
(All values measured at 20°C and 1 atm barometric pressure) |
| Sensor Response Time | All gas sensors: Rise time of 30 seconds (10-90%) | Same (30 seconds, 10-90% rise time for all gas sensors) |
| Temperature | Operating: +10 to +40°C
Storage: -20 to +50°C | Operating: +10 to +40°C
Storage: -20 to +50°C |
| Humidity | Operating: 20-95% RH non-condensing
Storage: 10-95% RH non-condensing | Same (Operating: 20-95% RH non-condensing; Storage: 10-95% RH non-condensing) |
| Ambient Pressure | Operating: 585 to 765 mmHg
Storage and Transport: 522 to 765 mmHg | Operating: 585 to 765 mmHg
Storage and Transport: 522 to 765 mmHg |
| Battery | a) sealed lead acid battery
b) 30 minutes back up when fully charged
c) 6 hours to full charge | a) same, sealed lead acid battery
b) 30 minutes back up when fully charged
c) 6 hours to full charge |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non-clinical testing for the ViaNOx Delivery System was completed in accordance with the Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer released by the FDA on January 24, 2000."
- Sample Size: The document does not specify a "test set" sample size in terms of the number of patients or clinical cases. The testing described is non-clinical performance data, which typically refers to bench testing, engineering verification, and validation. Therefore, sample sizes would relate to the number of units tested, number of trials, or range of tested parameters, but this is not detailed.
- Data Provenance: The testing was "non-clinical." This implies it was performed in a laboratory or engineering setting, not on actual patient data. The company, Pulmonox Medical Inc., is located in Edmonton, Alberta, Canada, so the testing would presumably have been conducted there or by a contracted lab. It is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described "non-clinical testing" does not involve human experts establishing ground truth for a clinical test set. The ground truth for performance testing of a medical device's technical specifications is typically derived from calibrated instruments and established engineering standards.
4. Adjudication Method for the Test Set
This is not applicable as the described testing is non-clinical and does not involve human interpretation or adjudication of results in the way a clinical study with image analysis or diagnosis would.
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
An MRMC comparative effectiveness study was not done. The document focuses on the technical characteristics and non-clinical performance of the device itself, not on human-in-the-loop performance or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of this device. The ViaNOx Delivery System is a hardware device with embedded software for controlling nitric oxide delivery and monitoring gas concentrations. Its performance is inherently "standalone" in the sense that it operates automatically to deliver and monitor gases. There isn't an "algorithm only" performance reported in the way one would for an AI diagnostic tool. The performance metrics (e.g., measurement accuracy, response time) are for the integrated device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the ground truth would be based on calibrated reference standards and laboratory measurements. For example:
- Gas Concentrations: Known concentrations of NO, NO2, and O2 generated by precision gas blenders or calibrated gas cylinders.
- Flow Rates: Measured using calibrated flow meters.
- Environmental Conditions: Controlled and measured using calibrated sensors for temperature, humidity, and pressure.
8. The Sample Size for the Training Set
This information is not applicable. The ViaNOx Delivery System is a hardware device with control software, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system involves robust engineering design, calibration, and verification against specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. There is no "training set" in the AI/ML context for this device.
§ 868.2380 Nitric oxide analyzer.
(a)
Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”