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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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The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.

The Lifestyle Circulatory Enhancer (CE) device is a non-sterile, single user device that is used within the external airway channel. Inspiration through the Lifestyle CE device provides temporary circulatory enhancement. Temporary circulation enhancement increases blood pressure, which has a positive effect on the symptoms of orthostatic hypotension. The technology providing temporary circulatory enhancement is the same as in the predicate ResQPOD CE devices.

The provided document does not contain acceptance criteria or detailed study results with specific performance metrics. It is a 510(k) summary for the "Lifestyle Circulatory Enhancer (CE)" device, focusing on its substantial equivalence to predicate devices and its intended use.

However, based on the information provided, here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., specific blood pressure increase, or reduction in orthostatic hypotension symptoms). The document focuses on "temporary circulatory enhancement" having a "positive effect on the symptoms of orthostatic hypotension."
• Reported Device Performance: The document states that the "safety and effectiveness of use of the Lifestyle CE device was demonstrated by bench qualification, animal study and a review of investigator sponsored clinical studies." However, no specific performance data (e.g., blood pressure changes, symptom reduction rates) from these studies are provided.

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

• Sample Size: Not provided. The document mentions "investigator sponsored clinical studies" but does not specify the number of participants.
• Data Provenance: Not provided. It's unclear if the studies were prospective, retrospective, or where they were conducted.

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)

• Number of Experts & Qualifications: Not applicable as the provided document does not describe a study involving expert assessment or ground truth establishment in that context (e.g., image interpretation). The "ground truth" for this device would likely be physiological measurements or patient-reported outcomes.

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

• Adjudication Method: Not applicable. This concept is typically relevant for studies where multiple readers or experts assess data and disagreements need resolution. The provided document doesn't detail such a process for the clinical studies mentioned.

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

• MRMC Study: Not applicable. This device is a "Circulatory Enhancer," not an AI diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is a medical device for circulatory enhancement, not an algorithm, so "standalone performance" in the AI sense is not relevant. The device is used by a single user within the external airway channel.

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

• Type of Ground Truth: Based on the device's function, the "ground truth" would likely involve objective physiological measurements (e.g., blood pressure, heart rate) and patient-reported outcomes (e.g., changes in lightheadedness, symptoms of orthostatic hypotension). However, the document does not specify how these were measured or confirmed in the mentioned studies.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

• Ground Truth for Training Set: Not applicable. As per point 8, there's no training set for this type of device.

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The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

The modified ResQPOD Circulatory Enhancer (CE) device is mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE reviewed and cleared for market in 510(k) K022906. This 510(k) submission was provided to review the following feature additions:
a) The addition of timing assist lights as a convenience to encourage proper inspiration rate through the ResQPOD CE;
b) Modified labeling to support use of the ResQPOD CE on alternative adjunctive airway devices, such as a mouthpiece, facemask with an ISO standard 22 mm connector, and endotracheal tube;
c) Provision for an ISO standard 15 mm to 22 mm adapter connector between the ResOPOD CE and the mouthpiece or facemask; and
d) Modified labeling to support use of the ResOPOD CE in clinic and emergency care locations with patients who, in the judgment of a physician or licensed professional, may need circulatory enhancement as provided by the ResQPOD CE.

The provided text describes a 510(k) submission for a modified ResQPOD™ Circulatory Enhancer. It outlines the changes made to the device and asserts its substantial equivalence to a predicate device. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that "The safety and effectiveness of use of the modified ResQPOD CE device was demonstrated by testing in compliance with the Design Control process." However, it does not specify what those acceptance criteria were (e.g., specific performance metrics, thresholds) nor does it report any quantitative performance results from such testing.

2. Sample Size Used for the Test Set and Data Provenance

Missing. The document refers to "testing in compliance with the Design Control process" but does not provide any specifics about a test set, its sample size, or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Missing. Given that no specific test set or performance evaluation is detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Missing. No information on adjudication methods is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Missing. There is no mention of an MRMC study or any comparative effectiveness study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Missing. This device is a mechanical circulatory enhancer, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable here.

7. The Type of Ground Truth Used

Missing. As no specific performance data or studies are detailed, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Missing. No training set is mentioned as this device is not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Missing. Not relevant as it's not an AI/ML device.

Summary of available information related to acceptance criteria and study:

The document states that the modified device is "mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE" and that its "intended use and technology...is substantially equivalent to the predicate, unmodified device." The primary basis for the 510(k) submission is to review feature additions and modified labeling, not to demonstrate new performance insights through extensive clinical trials.

The "study" referred to is the internal "testing in compliance with the Design Control process." This implies that the device satisfied internal design verification and validation requirements, but these are not explicitly detailed in terms of public acceptance criteria or reported performance metrics within this 510(k) summary. The FDA's letter acknowledges this submission as a review for "substantial equivalence" to the predicate device, meaning its safety and effectiveness are deemed comparable, without requiring extensive new clinical performance data to be presented in this document.

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