(64 days)
The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.
The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The INOblender is designed to take constant oxygen (02) gas flow (5 to 14 L/min) from the integrated O2 flowmeter and blend in NO at the setting on the NO blender's concentration control dial (5 to 80 ppm). The NO blender is calibrated for cylinder concentrations of 800 ppm NO in a balance of nitrogen (N2).
The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices. This document is a 510(k) summary for a medical device called INOblender®, which is a Nitric Oxide administration apparatus.
Here's why the requested information cannot be fully provided from this document:
- Device Type: The INOblender® is a physical medical device (blender for gas delivery), not an AI/ML diagnostic software or algorithm. Therefore, the concepts of "algorithm only performance," "human readers improve with AI," "ground truth establishment" of a "test set" and "training set" in the context of diagnostic accuracy are not applicable.
- Study Type: The submission is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or effectiveness through clinical trials in the sense of AI/ML performance.
However, I can extract information related to the device's non-clinical testing which serves as the "study" demonstrating its capabilities.
Here's a breakdown of the available information based on your request, adapted to the context of this physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative table with specific targets and achieved results. Instead, it lists four requirements that were tested for compatibility with a new respiratory care device. The "reported device performance" is the conclusion that these requirements were met.
| Requirement/Criterion | Reported Device Performance |
|---|---|
| O2 dilution (Compatibility with respiratory care device) | Met: Device was set up, calibrated, and tested. |
| Effect on respiratory care device (Compatibility) | Met: Device was set up, calibrated, and tested. |
| INOblender® NO dose delivery accuracy (Performance) | Met: Device was set up, calibrated, and tested. |
| NO2 generation (Safety/Performance) | Met: Device was set up, calibrated, and tested. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of diagnostic data. The "test set" here refers to the device itself and its interaction with a specific new respiratory care device. The testing was conducted by setting up the INOblender® and the new respiratory care device. The number of such setups or repetitions is not specified, but it's not data in the sense of patient cases.
- Data Provenance: Not applicable in the context of diagnostic data. The "testing" refers to equipment performance validation, likely conducted in a laboratory setting by the manufacturer. Details like country of origin for such engineering tests are not provided and typically not relevant for this type of submission. The tests were "non-clinical."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this type of device. The "ground truth" for these tests would be the known operational parameters and specifications of the devices themselves and the physical/chemical measurements taken during the compatibility and performance tests.
- Qualifications of Experts: Not applicable. The "experts" involved would be engineers and technicians performing the physical and chemical tests, adhering to established protocols. Their specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data. For physical device performance testing, the results are typically objectively measured and compared against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of the INOblender®.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The INOblender® is a physical device that functions to deliver gas, not an algorithm. Its "standalone" performance would relate to its ability to accurately blend and deliver gases according to its specifications. The document states "INOblender® NO dose delivery accuracy" was tested, which can be considered a standalone performance aspect for the device's primary function.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the non-clinical tests was established by known engineering specifications, physical/chemical measurement standards, and the manufacturer's recommendations for calibration and operation. For example, "NO dose delivery accuracy" would be compared against a known, precise NO concentration generated by the device itself or measured by a calibrated external sensor.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI/ML algorithm involved, so there is no "training set" in the context of machine learning. The device is hardware-based, relying on established physical and chemical principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable for the reasons mentioned above.
Summary of Device-Specific Information:
- Device Name: INOblender®
- Intended Use: To provide user-set concentrations of inhaled Nitric Oxide (NO) mixed into a constant flow of oxygen gas. Intended as a backup to a primary NO delivery system or for short-term attended use when a primary device is impractical.
- Technology: Component technology (blender, regulator, NO gas tank).
- Predicate Device: K052663 (another INOblender® with slightly different labeling for compatibility with resuscitators).
- Non-Clinical Tests:
- O2 dilution
- Effect on respiratory care device (compatibility with Fisher & Paykel NeoPuff)
- INOblender® NO dose delivery accuracy
- NO2 generation
- Clinical Tests: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." (Meaning, no clinical tests were performed for this specific submission, as it relied on non-clinical data and substantial equivalence to a predicate).
§ 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.”