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ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:

1. The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
2. Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
3. Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.

Here's a breakdown of the acceptance criteria and the study information for the ClearMate device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

The document primarily discusses preclinical (animal and bench) and clinical literature review, rather than a single prospective "test set" for the device itself in the traditional sense of an AI/algorithm.

• Bench Testing:

  • Breathing Circuit Performance: 10 samples of spontaneously breathing circuits and 10 samples of non-spontaneously breathing circuits (20 samples total).
  • Control Unit Performance: 10 control units.
  • Use Life Performance: 5 device samples.
  • Data Provenance: Retrospective, conducted by the applicant (Thornhill Research, Inc.) presumably in Canada (given the contact address is in Scottsdale, AZ, but the company is Thornhill Research, Inc., which is Canadian). This is inferred as internal testing presented to the FDA.

• Animal Studies:

  • Fisher JA et al. (1999): Dog model (specific N not provided in the summary). Provenance: Published U.S. study.
  • Krech T et al. (2001): Mechanically ventilated sheep (specific N not provided in the summary). Provenance: Published U.S. study.

• Human Clinical Literature Review (considered as evidence of effectiveness):

  • Anand et al. (2017): 13 healthy volunteers (chronic smokers). Provenance: Published study (journal name "PLOS One" suggests an international publication, DOI:10.1371/journal.pone.0170621).
  • Rucker et al. (2002): 14 healthy volunteers. Provenance: Published U.S. study.
  • Takeuchi et al. (2000): Healthy human volunteers (specific N not provided in the summary). Provenance: Published U.S. study.
  • Katznelson et al. (2008): Specific N not provided in the summary (anesthetic agents study). Provenance: Published study.
  • Katznelson et al. (2011): 44 obese elective surgical patients (anesthetic agents study). Provenance: Published study.
  • Wu et al. (2015) - external study, not used for efficacy but for safety: 319 patients in treatment group, 320 in control group. Provenance: Chinese study, published in "Chinese Journal of Clinicians."

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

This device is not an AI/algorithm requiring expert-established ground truth for a test set in the diagnostic sense. The "ground truth" for its performance is derived from:

• Bench Testing: Engineering specifications and physical measurements. Experts involved would be engineering and quality control personnel. Their specific qualifications are not detailed, but they would be presumed to be qualified engineers/technicians.
• Animal Studies: Scientific observation and measurement by researchers/veterinarians.
• Human Clinical Studies: Clinical endpoints (e.g., COHb levels, elimination half-life, cerebral blood flow) measured by medical professionals and researchers. The peer-review process for these published studies implicitly involves expert clinicians and scientists.

4. Adjudication Method for the Test Set:

Not applicable, as this is not an AI/diagnostic algorithm using expert review for a "test set." For the literature review, the FDA's internal review team served as the adjudicators of the existing scientific evidence.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study, in the context of human reader performance with/without AI assistance, was not performed. The device is a physical therapeutic device, not a diagnostic AI system intended to assist human readers.

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

Yes, the device itself is the "standalone" component. Its performance was evaluated independently through bench testing (as detailed in item #2) and animal studies. The human clinical studies also assess the device's effect on physiological markers when used therapeutically.

7. The Type of Ground Truth Used:

• Bench Testing: Device specifications, physical properties, engineering standards, and direct measurement of gas concentrations, flow rates, and pressures.
• Animal Studies: Physiological measurements (e.g., COHb levels, cardiac output, oxygen delivery) directly measured from the animal subjects.
• Human Clinical Studies (for effectiveness): Physiological measurements (e.g., COHb levels, elimination half-life, cerebral blood flow) obtained from human volunteers or patients using established medical measurement techniques.
• Human Clinical Study (Wu et al. for safety, but with limitations on efficacy): Clinical outcomes adjudicated by medical personnel based on consciousness, continence, disappearance of CO poisoning signs, EEG findings, and BI (Barthel Index) scores.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set in the machine learning sense. The device's design is based on scientific principles of isocapnic hyperventilation, not data training.

9. How the Ground Truth for the Training Set was Established:

Not applicable (as above). The design and performance targets for the ClearMate device are based on established physiological principles and engineering requirements, not on a "ground truth" derived from a training dataset for an AI algorithm.

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