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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/Nz is controlled to maintain a steady concentration of NO/Nz 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/N2 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 plumbing 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 is a 510(k) summary for the ViaNOx Delivery System, Model II, and primarily focuses on comparing it to its predicate device and outlining its intended use. It does not contain specific acceptance criteria, reported device performance metrics (such as sensitivity, specificity, accuracy), or details of a study designed to prove the device meets such criteria.

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 as applicable to this modification only."
• "All testing was performed as recommended where applicable and where not applicable, or where testing deviated from the recommendations, an explanation as to how the ViaNOx Delivery System met safety and efficacy concerns was documented."
• "Based on the non-clinical testing performance and the comparison to the predicate, the ViaNOx Delivery System is safe for use and is substantially equivalent to the predicate."

This language indicates that performance testing was conducted to address safety and efficacy concerns relevant to the device modification, but it does not specify the quantitative acceptance criteria or the detailed results of such tests in the provided text. The submission is a "substantial equivalence" determination based on technological characteristics and regulatory guidance rather than a performance study with specific statistical endpoints.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document refers to compliance with a "Guidance Document for Premarket Notification Submissions," implying that the device was evaluated against general safety and efficacy requirements for this type of device, but specific quantitative acceptance criteria and corresponding performance metrics are absent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "non-clinical testing" but does not detail sample sizes, data provenance, or whether the tests were on a "test set" in the context of an algorithm's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this device is a nitric oxide delivery and monitoring system, not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device; it's a medical device for gas delivery and monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in terms of diagnostic ground truth for an algorithm. For a device like this, ground truth would likely refer to calibrated measurements against known gas concentrations or stable physiological parameters in a test environment, but details are not provided.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission for a medical device (a nitric oxide delivery system) and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with specific acceptance criteria and results related to an algorithm's performance.

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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.

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.

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