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Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Breezing Med™ Metabolism Analyzer is a resting metabolic rate measurement system with an application installed on mobile devices that provides measurements of exhalation rate, oxygen uptake and carbon dioxide production. It is used to determine resting metabolic rates, teach energy balance, and pinpoint accurate caloric intake for weight management.

Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02.

Breezing Med measures the expiratory volume similar to the predicate device Medical Graphics Express® Series.

Breezing Med consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

The acceptance criteria information can be found on page 4, under item 8, "Performance Data."

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

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

The document does not specify the sample size, country of origin, or whether the data was retrospective or prospective for the performance study. It mentions a "verification test" and a "study to simulate clinical use."

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)

This information is not provided in the document. The performance data seems to be based on direct measurements and comparison to performance specifications of the predicate device, rather than expert-established ground truth.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device measures metabolic functions and does not involve human readers interpreting data in a way that an MRMC study would be applicable.

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

Yes, a standalone performance assessment was done. The "verification test" and "study to simulate clinical use" assessed the device's ability to measure O2 volumes, CO2 volumes, and flow rates against established specifications. The device operates as a standalone measurement system.

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

The ground truth for the performance study appears to be the specified accuracy ranges derived from the predicate device (Medical Graphics Express® Series). The device's measurements were compared against these predefined accuracy thresholds for O2 volumes, CO2 volumes, and flow rates. These specifications likely represent a gold standard for indirect calorimetry measurements.

8. The sample size for the training set

The document does not mention a training set, as it describes a medical device for direct measurement rather than an AI/ML algorithm that undergoes a training phase.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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