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The Economizer Conserving Requlator is used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

Device Description

The Inovo, Inc., Economizer Conserving Regulator is a high pressure oxygen requlator and conserving device that is combined into a single compact unit. It operates in the same manner as traditional oxygen pressure regulators with the added benefit of having a conserving device included. It is constructed with an aluminum one piece body with all brass in the high pressure zones. The system is designed for an ambulatory patient with a high pressure oxygen cylinder. This unit requires no electrical power source. It operates with an operating pressure of 200 to 3000 psig and a nominal outlet pressure of 22 psi.

The device can function as a standard continuous flow regulator or as a conserving device which will double a patient's ambulatory time over that of a continuous oxygen system.

In conserving mode, the flow of oxygen is controlled by the patients inhalation and exhalation, which triggers a sensing diaphragm within the control module. As a result, the unit starts flowing oxygen when the user begins the inhalation cycle. Conversely, the unit shuts off the flow of oxygen when the user ceases inhalation.

It includes a click style flow control with selectable outlet flow that ranges 1 to 6 LPM by .5 LPM increments. The device can easily be switched between continuous or conserve mode without turning the device off.

The device uses a dual lumen cannula attached to two outlet ports. The first port senses the inhalation of the patient . The second port delivers the oxygen. In the "Conserve" mode, the device should be used only with the Hudson Dual Lumen Cannula (K# 961150) or a cannula with the same pneumatic characteristics.

AI/ML Overview

The provided text describes a 510(k) summary for the Inovo, Inc. Economizer Conserving Regulator. This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It explicitly states "Clinical Tests Performed: Not Applicable," meaning no human studies were conducted for this submission.

Therefore, an acceptance criteria table and information regarding human study parameters (sample size, experts, adjudication, MRMC studies, standalone performance) cannot be extracted from this document, as such studies were not performed or reported.

However, based on the non-clinical tests performed, we can infer the types of acceptance criteria that would have been used for each test.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance/Rationale for Acceptance
Material & Safety	ASTM G175	Not explicitly stated; implied to meet standard requirements for oxygen service materials.
Conserving Function	Conservation Test	Not explicitly stated; implied to achieve desired oxygen conservation (e.g., doubling ambulatory time).
Flow Accuracy	Flow Regulation Test	Not explicitly stated; implied to deliver prescribed flow accurately (1 to 6 LPM by .5 LPM increments).
Responsiveness	Flow Response Test	Not explicitly stated; implied to have appropriate response time for sensing inhalation and delivering oxygen.
Durability/Pressure	Proof Pressure Test	Not explicitly stated; implied to withstand specified proof pressure.
Structural Integrity	Hydrostatic Test	Not explicitly stated; implied to withstand specified hydrostatic pressure.
Environmental Robustness	Environment Testing	Not explicitly stated; implied to perform reliably under various environmental conditions.
Overall Equivalence	Comparison to Predicate Devices	"No differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. The efficacy and safety were evaluated through non-clinical (bench) testing, not on a human test set.
Data Provenance: Not applicable for human data. All data is from non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable. No human test set requiring adjudication was used.

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 an oxygen conserving regulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The "standalone performance" in this context refers to the device's function as an oxygen conserving regulator. All the performance tests listed (Conservation Test, Flow Regulation Test, Flow Response Test, etc.) represent the device's standalone performance in a simulated or bench environment.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was established by engineering specifications, industry standards (e.g., ASTM G175), and established criteria for functional performance of oxygen delivery devices. For example, a flow regulation test would be evaluated against calibrated flow meters, and a conservation test against expected oxygen consumption metrics.

8. The sample size for the training set:

Not applicable. This device is a mechanical/pneumatic device and does not involve machine learning or an algorithm that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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