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The Inovo Independence Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The Independence senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen regulators. The Independence Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The Independence then delivers oxygen to the patient by sensing the beginning of inhalation using a pressure switch, which opens a solenoid valve for a specific period of time controlled by a microprocessor. The unit is designed to deliver 16 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM. The unit is powered by a single "AA" battery. The Independence also has a continuous flow back-up mode that delivers selectable continuous flow in the event of battery or device failure. The device has a two-color LED to indicate battery status. By depressing a "Battery test" switch, the device will show a Green light to indicate the battery is good. When the battery is below 0.9 vDC, the LED will be Red, indicating the battery must be changed. Under any circumstance, the "Continuous" mode can supply oxygen therapy in the event of battery failure. Patient inspiration is detected by a pressure switch set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a in the fango on at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.

I am sorry, but the provided text does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the format requested.

The document is a 510(k) summary for the Inovo, Inc. Independence Conserving Regulator, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance criteria.

Here's what the document does provide in relation to your request:

• 1. A table of acceptance criteria and the reported device performance: This is not present in a tabular format detailing specific criteria (e.g., accuracy, reliability) and the numerical performance against them. The document lists "Performance Testing Included" such as Promoted Ignition ASTM G175, Hydrostatic Test, Proof Pressure Test, Conservation Test, Flow Regulation Test, Environmental Testing, and Electromagnetic Compatibility, but it does not specify the acceptance criteria for each or the reported results.
• 2. Sample sized used for the test set and the data provenance: This information is not provided. The document mentions "bench testing contained in our submission and non-clinical testing supplied" but does not detail sample sizes or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable and not mentioned, as there was no clinical study.
• 4. Adjudication method for the test set: Not applicable and not mentioned, as there was no clinical study.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it explicitly states "Discussion of Clinical Test Performed: Not Applicable."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone medical device, but there isn't a "standalone algorithm performance" in the context of an AI-driven device, as this is a mechanical/electronic oxygen regulator. The performance tests ("bench testing," "non-clinical testing") would represent standalone device performance.
• 7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering standards and specifications (e.g., ASTM G175 for promoted ignition, industry standards for hydrostatic and proof pressure tests, and internal specifications for conservation and flow regulation).
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's primary goal is to establish substantial equivalence to predicate devices through non-clinical performance testing and comparison of technological characteristics, rather than a detailed report of clinical study results against specific, quantified acceptance criteria.

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