(154 days)
The EZ-OX Plus is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure requlator, flow meter and medical E-Oxygen cylinder with handle and shroud all integrated into a single, lightweight unit. Key specifications include hose barb connection, protective cap, carrying handle, easy to read content gauge, indexed flow meter, integrated regulator and usage chart label with safety instructions. Medical personnel can concentrate on providing patient care and treatment sooner without delays caused by the need to mount a regulator. With no assembly needed and the easy-to-use design, it is easy to operate.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The EZ-OX Portable Oxygen System is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. 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.
The provided text describes a 510(k) summary for the EZ-OX Plus Portable Oxygen System, focusing on demonstrating its substantial equivalence to a predicate device rather than presenting a study proving it meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth for training set was established) are not explicitly present in the document because it's a regulatory submission for device clearance, not a clinical trial report.
However, I can extract information related to performance data and safety testing, which act as a form of acceptance criteria for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are primarily defined by adherence to recognized standards and demonstrated performance in safety tests comparable to, or in some cases exceeding, those required for its classification and substantial equivalence to the predicate device.
| Parameter (Acceptance Criteria) | Reported Device Performance (EZ-OX Plus) |
|---|---|
| Cylinder Standards | Conforms to 49 CFR 178.46: Specification seamless aluminum cylinders. |
| Regulator Ignition Sensitivity | ISO 10524 / EN-738-3 (Equivalent): Tested for resistance to ignition by pressure shock tests (max temperature and pressure shocks up to max pressure). Demonstrated "no ignition or damage to internal parts or areas within the regulator." Conducted in various configurations of regulator valve and shut-off valve. |
| Ignition by Particle Impact Risk | Designed to decrease risk: Incorporates a 60 micron filter at the filling connection, a 60 micron filter at the valve-regulator inlet, and a 20 micron filter in the seat of the regulator (even though ASTM G 175 with a positive ignition source wasn't required by EN-738-3/ISO 10524 for this specific test, the design addresses the risk). |
2. Sample size used for the test set and the data provenance
Not applicable as this is not a clinical study involving a "test set" of patients or data in the typical sense. The "testing" refers to benchtop and component-level evaluations, not clinical data sets.
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. Ground truth for this type of device (mechanical/electrical safety and performance) is established via recognized engineering standards and test protocols, not expert clinical consensus on a "test set."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies where subjective assessments might be made (e.g., by human readers of medical images). This document describes objective engineering tests.
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 device is a portable oxygen delivery system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system. Its performance is inherent to its mechanical design and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by adherence to recognized international and national engineering/safety standards (e.g., 49 CFR 178.46, ISO 10524, EN-738-3) and successful completion of specified physical and mechanical tests outlined within those standards. This includes evaluating the regulator's resistance to ignition under specific pressure and temperature conditions.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device clearance. The device is designed, manufactured, and tested to specifications, not "trained" like a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.