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The Inovo AccuPulse Single Lumen Pneumatic 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. AccuPulse 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 AccuPulse 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 requlators.

The AccuPulse Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The AccuPulse then delivers oxygen to the patient by sensing the beginning of inhalation using a diaphragm, which opens a sliding valve for a specific period of time controlled by pneumatic timing. The unit is designed to deliver 12 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM.

The AccuPulse also has a continuous mode that delivers selectable continuous flow in the event of device failure.

Patient inspiration is detected by a pressure-sensitive diaphragm set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a bolus of oxygen 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.

This 510(k) summary describes a medical device, the Inovo, Inc. AccuPulse Conserving Regulator, which is an oxygen conserving device. The information provided is for regulatory clearance and does not detail a study in the context of typical clinical trials with specific acceptance criteria outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided text in relation to your questions:

Device Acceptance Criteria and Performance (as determined by non-clinical testing for substantial equivalence)

The document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds that need to be met for clinical effectiveness. Instead, the "acceptance" is based on demonstrating that the device performs similarly to predicate devices and does not raise new questions of safety or effectiveness. The performance testing conducted is described as "Non-Clinical Test Performed for Determination of Substantial Equivalence."

The "reported device performance" is summarized by stating that "non-clinical testing supplied demonstrates that there are no differences in their performance characteristics."

Study Details Based on the Provided Text:

This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical (human) studies to establish new safety or effectiveness claims with specific acceptance criteria and ground truth.

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

• Test Set Sample Size: Not applicable. This was a non-clinical performance testing (bench testing), not a clinical trial with a "test set" of patient data. The tests were performed on the device itself.
• Data Provenance: Not applicable, as there is no patient data or clinical data described. The tests were performed in a lab setting by the manufacturer.

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

• Not applicable. There was no "ground truth" derived from expert consensus for a test set of patient data. The performance tests are objective measurements of the device's physical and functional characteristics.

3. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process for clinical outcomes is described.

4. 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 pneumatic oxygen conserving regulator, not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This is not an algorithm or AI device. The device operates independently once set by a healthcare provider for a patient's prescribed flow. The "standalone" performance was demonstrated through the non-clinical bench tests.

6. The type of ground truth used:

• For the non-clinical performance and safety tests, the "ground truth" implicitly refers to engineering specifications, recognized industry standards (e.g., ASTM G175), and the performance characteristics of predicate devices. The device's performance was measured against these objective criteria rather than against expert consensus or pathology in a clinical setting.

7. The sample size for the training set:

• Not applicable. This device is a mechanical/pneumatic device. There is no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 7.

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