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510(k) Data Aggregation
(119 days)
PRAXAIR MEDICAL AIR MIXER
The Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician.
The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.
The PROGENAIRE™ Compressor-free Medical Air system is a device which mixes oxygen and nitrogen from hospital bulk supply systems to provide a product Medical Air USP.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PROGENAIRE™ Compressor-free Medical Air system:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Limits) | Reported Device Performance (Oxygen Concentration) |
|---|---|
| 19.5% - 23.5% | Within USP limits (19.5% - 23.5%) |
2. Sample Size and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical trials or retrospective/prospective data for algorithm evaluation. The testing described focuses on bench and environmental testing to verify the device's adherence to technical specifications.
- Sample Size for Test Set: Not applicable as the testing described is primarily engineering/bench testing, not data-driven algorithm testing.
- Data Provenance: Not applicable in the context of clinical data for algorithm testing. The evaluation is based on the performance of the physical device under lab conditions.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth for this device's performance (oxygen concentration) is established by the United States Pharmacopeia (USP) standards, which define the acceptable range for medical air. This is a regulatory standard, not a subjective interpretation by experts.
4. Adjudication Method:
Not applicable. Ground truth is defined by objective USP standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is typically performed for imaging or diagnostic algorithms where human readers' performance with and without AI assistance is compared. This document describes a physical medical device (medical air mixer), not an AI-powered diagnostic tool.
6. Standalone Performance:
Yes, the testing described is a standalone performance evaluation of the Praxair PROGENAIRE™ Compressor-free Medical Air system itself. The document states: "These tests confirmed that the mixer produces Medical Air within USP limits for oxygen concentration, 19.5% - 23.5%." This indicates the device's inherent ability to meet the specified performance, independent of human interaction beyond initial setup and monitoring.
7. Type of Ground Truth Used:
The ground truth used is regulatory standards/pharmacopeia standards, specifically the USP limits for oxygen concentration in Medical Air (19.5% - 23.5%).
8. Sample Size for Training Set:
Not applicable. This device is a physical medical air mixer, not an AI/machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable, as no training set for an AI algorithm was involved.
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