(304 days)
The EZ-OX Plus Generation II is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
The EZ-OX Plus Generation II portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical D and E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flowrate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 40 L/min oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, integrated valve-regulator and usage chart label with safety instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
Here's a breakdown of the acceptance criteria and study information for the EZ-OX Plus Generation II Portable Oxygen System, based on the provided document:
Acceptance Criteria and Device Performance
This device is not an AI/ML device, so many of the common fields for such devices (e.g., number of experts, adjudication methods, MRMC studies, ground truth for training data) are not applicable. The provided document details the testing performed to demonstrate the safety and effectiveness of the updated medical device in comparison to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Device: EZ-OX Plus Generation II Portable Oxygen System
| Acceptance Criteria | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Accuracy | ISO 10524-3:2005 | Demonstrates accuracy, all flow rates met acceptance criteria, proposed device more accurate than predicate. |
| Precision | Standard Deviation ≤ 2.0 (USP & ICH community supported) | All obtained results were passing, improved precision over predicate device. |
| Safety Testing | ISO 10524-3 (Outlet flow limit, Safety valve test, Leakage rate, Adiabatic compression test) | Successfully completed. |
| Safety Testing | EN 15996 (Characteristics of functional at reception, Tightness at reception, RPV performance test, Tightness after endurance, Characteristics of functional after endurance) | Successfully completed. |
| Safety Testing | ASTM G175-03 (Promoted ignition test) | Successfully completed. |
| Cylinder Conformance | 49 CFR 178.46, Specification seamless aluminum cylinders | Aluminum cylinders conform. |
Note: The document focuses on demonstrating that the updated device meets established safety and performance standards for portable oxygen systems, and also shows improvements over its predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of devices tested or data points collected for the performance bench testing. It states that testing was "performed across the entire range of user configurable flow control settings."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal validation by Air Liquide Healthcare America Corporation. The document does not specify if the testing was retrospective or prospective, but as it's for a new device's 510(k) submission, it would inherently be prospective testing for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of medical device submission. The "ground truth" for a portable oxygen system's performance is established by objective engineering and safety standards (e.g., flow rate measurements, leakage tests, material strength), not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective measurements against engineering and safety standards. There is no subjective interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic or prognostic AI/ML devices where reader performance is a key metric. This device is a mechanical portable oxygen system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The device is a physical medical device, not a software algorithm. Its performance is measured directly through bench testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Established Industry Standards: Specifically, ISO 10524-3:2005 for accuracy and EN 15996 and ASTM G175-03 for safety.
- USP (United States Pharmacopeia) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines: Supported standard deviation for precision.
- Engineering Specifications: Conformance to 49 CFR 178.46 for cylinders.
These standards and specifications define what constitutes acceptable "truth" in terms of device function and safety.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, and there is no "training set" in the context of machine learning or AI. The design modifications and improvements (e.g., excess flow device, brass orifice plate, vent holes, non-shuttling RPV) are based on traditional engineering design, analysis, and validation, not on a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The improvements and design changes were driven by engineering analysis to increase safety and performance, address potential failure modes (even if not yet observed), and enhance user experience (e.g., eliminating audible vibration).
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.