(106 days)
The Evolve DS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.
The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.
This submission is for an updated labeling for compatibility with additional ventilator and breathing devices for the EVOLVE Nitric Oxide Delivery System, not a new device or a software-driven diagnostic. Therefore, the detailed information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment typically required for AI/ML device studies is not available in this document.
The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K222930) by evaluating the impact of new ventilator compatibility labeling.
Here's an analysis based on the provided text, addressing the requested points where information is available or applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria and reported device performance in the context of an algorithmic diagnostic. Instead, it refers to the performance of the overall EVOLVE Nitric Oxide Delivery System, which is a hardware-based medical device.
The "Summary of Non-Clinical Tests" section mentions:
"The Mallinckrodt Ventilator / Gas Delivery System Validation Test Protocol was used to validate the hazards identified from risk input were mitigated. Testing was conducted across all platforms to demonstrate that the EVOLVE DS performs within published specifications. Ultimately, the requirements necessary for the operation of the EVOLVE Nitric Oxide Delivery System passed."
This indicates that the acceptance criteria were likely related to the device working within its published specifications when interfaced with the new ventilators, and the reported device performance was that it "passed" these requirements. However, specific quantitative metrics are not provided.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device performs within published specifications when used with additional ventilator devices. | "Ultimately, the requirements necessary for the operation of the EVOLVE Nitric Oxide Delivery System passed." |
| Hazards identified from risk input are mitigated. | Validation testing confirmed mitigation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in the document. The study was a non-clinical validation test of device compatibility, not a clinical study on patient data.
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)
This information is not applicable. The "ground truth" here would be the functional performance of the device and its compatibility with ventilators, established through engineering and technical validation rather than expert clinical consensus on diagnostic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations. This was a non-clinical validation.
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, an MRMC comparative effectiveness study was not done. The submission is not for an AI device or a diagnostic requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a hardware delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for this non-clinical validation was the functional performance of the device and its compatibility with the listed ventilators according to its published specifications and safety requirements. This would be established through engineering tests and measurements, rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable. There is no training set as it's not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set.
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(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.”