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K Number
K190800
Device Name
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
Manufacturer
Cosmed Srl
Date Cleared
2020-02-06

(315 days)

Product Code
BTY
Regulation Number
868.1890
Type
Traditional
Panel
AN
Reference & Predicate Devices
K162515,K071533,K120146
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

  • Spontaneously breathing subjects >15 kg (33 lb) when using a canopy;

  • Spontaneously breathing subjects age >6 and > 10 kg (22 lb) when using a face mask;

  • Ventilated subjects age >10 and >10 kg (22 1b).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).

Device Description

The Q-NRG and Q-NRG+ devices are Portable Metabolic Monitors, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and mechanically ventilated patients.

AI/ML Overview

The provided text describes the Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors, a medical device for measuring Resting Energy Expenditure (REE). The document highlights the device's technical specifications and comparisons to a predicate device (Quark RMR Metabolic Cart) to establish substantial equivalence.

However, the provided text does not contain the specific information required to answer your questions regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/human comparative effectiveness study. The document focuses on regulatory clearance and device performance and safety against general medical device standards.

Here's a breakdown of why the information you're looking for is not present:

  • No mention of AI/machine learning: The device is described as a "Portable Metabolic Monitor," suggesting direct measurement or calculation based on sensor data, not an AI or machine learning algorithm requiring human-in-the-loop performance studies.
  • No stated acceptance criteria for an AI algorithm: The "Accuracy Validation" section mentions internal validation protocols for mask, canopy, and ventilator measurement accuracy, with specific percentages for Ventilation, VO2, and VCO2 (e.g., Ventilation:

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).