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The CirQlator™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.

The CirQlator"M is an intrathoracic pressure regulator intended to interface with the airway of a patient and a ventilation source. A vacuum source is connected to the ITPR that provides continuous low-level vacuum except when a positive pressure breath is given by a ventilation source, e.g. manual resuscitator. The applied vacuum decreases the intrathoracic pressure. When interposed between positive pressure ventilations, a decrease in intrathoracic pressure has been shown to increase vital organ perfusion and decrease intracranial pressure during states of shock, cardiac arrest, and other low blood flow states in animal studies.

The provided text describes the regulatory clearance of a medical device, the "CirQlator™ Intrathoracic Pressure Regulator (ITPR)," rather than a performance study that establishes acceptance criteria for an AI/CADe device. Therefore, much of the requested information about AI performance, expert review, and ground truth is not applicable to this document.

However, I can extract information related to the device's intended performance as established for its 510(k) clearance based on substantial equivalence.

Here's a breakdown of what can be inferred and what cannot:

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

The document doesn't define explicit numerical acceptance criteria in the manner one would for an AI device's sensitivity, specificity, etc. Instead, the acceptance criterion for regulatory clearance via 510(k) is substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not specified. The document mentions "animal testing" but doesn't provide the number of animals or any details about their provenance.
• Data provenance: "Animal testing" and "bench testing." No country of origin is mentioned for the data. The data appears to be prospective as it was conducted specifically to demonstrate the device's performance.

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. This is not an AI/CADe study involving human image interpretation or clinical outcomes adjudicated by experts. The performance was assessed through bench and animal testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/CADe study requiring expert adjudication of results.

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 is a standalone medical device, not an AI/CADe system designed to assist human readers.

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

Yes, in a sense. The "Performance testing" details "comparative bench testing" and "animal testing" which evaluate the device's function and performance intrinsically, without a human-in-the-loop interacting with an algorithm output. The device itself is a standalone piece of equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the animal testing would involve physiological measurements and observations related to "increase vital organ perfusion and decrease intracranial pressure during states of shock, cardiac arrest, and other low blood flow states," as mentioned in the device description. For bench testing, the ground truth would be engineering specifications and expected physical performance. The document doesn't provide specifics on these "truths."

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that requires a training set.

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

Not applicable. No training set was used.

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