(115 days)
This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.
Fitmate is designed for measuring oxygen uptake at rest and during exercise (VO2max). The device is a metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake), during a sub-maximal or maximal exercise protocol. Fitmate series family includes Fitmate and Fitmate Pro. Fitmate is specifically designed for the measurement of Resting Metabolic Rate only, and Fitmate Pro includes also the measurement of maximal oxygen uptake (VO2max).
Here's a breakdown of the acceptance criteria and study information for the COSMED Fitmate device as provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria values (e.g., a required accuracy percentage or range) for the Fitmate device. Instead, the claim for substantial equivalence is based on the device having the same intended use and substantially the same characteristics as the predicate devices and meeting a general standard.
However, it does mention a standard that the device meets, which implies a level of performance.
| Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|
| Meet EMC standard EN60601-1-2 for accuracy of measurement of flows and volumes | All systems (including Fitmate) meet the EMC standard EN60601-1-2 for accuracy of the measurement of flows and volumes. |
| Same intended use as predicate devices | Designed for the same intended use (measure oxygen uptake, RMR, VO2max). |
| Substantially same characteristics as predicate devices | Has substantially the same characteristics as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting the results of a specific performance study with a defined test set. The data provenance is also not explicitly stated as the document references compliance with a standard rather than a specific study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document as it does not detail a specific performance study requiring expert adjudication.
4. Adjudication Method 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
No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study comparing human readers with and without AI assistance is not relevant to the information provided for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The document does not describe a standalone algorithm performance test. The Fitmate is a physical medical device designed to measure physiological parameters, not an AI algorithm.
7. The Type of Ground Truth Used
The document does not describe a specific ground truth for a test set in the context of a performance study. The "ground truth" for demonstrating the device's accuracy is implied to be its conformance to the EMC standard EN60601-1-2 for measurement accuracy and its functional equivalence to other legally marketed devices.
8. The Sample Size for the Training Set
This information is not relevant and therefore not provided in the document. The Fitmate is a device that collects physiological data directly, it is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not relevant and therefore not provided in the document, as there is no training set for this device.
§ 868.1730 Oxygen uptake computer.
(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).