(58 days)
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: Oxygen uptake, Carbon dioxide excretion, Expiratory minute ventilation. Calculated/derived parameters: Oxygen uptake per kg, Respiratory exchange ratio, Alveolar ventilation, Anatomical dead space (Fowler dead space), Tidal volume, Respiratory rate, End-tidal concentration of oxygen, End-tidal concentration of carbon dioxide, Expiratory quotient / ventilatory equivalent for oxygen, Expiratory quotient / ventilatory equivalent for carbon dioxide. And the following calculated parameters after an incremental exercise test: Anaerobic threshold, Respiratory compensation, Rest values, Values at AT point, Values at max exercise.
Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Breath-by-Breath option provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (VE) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests. This gives the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.
The provided text describes the Cardiopulmonary Exercise Testing Option to Innocor. Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device has been shown through bench testing to be substantially equivalent to the predicate device. However, specific numerical acceptance criteria for performance metrics (such as accuracy, precision, or deviation) and the exact reported device performance metrics are not detailed in the provided text. The statement is a general claim of equivalence.
| Parameter/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measurement of metabolic parameters on a breath-by-breath basis | Substantially equivalent to Medical Graphics Ultima System, K061731 | Shown to be substantially equivalent to Medical Graphics Ultima System, K061731 through bench testing |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" but does not specify a sample size for the test set. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts or provide details about their number or qualifications in establishing ground truth for the bench testing. The comparison is made against a legally marketed predicate device.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
An MRMC comparative effectiveness study was not conducted as per the provided information. The study described is a bench test for device equivalence, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The study was described as "bench testing" to demonstrate substantial equivalence to a predicate device. This implies a standalone (algorithm/device only) performance evaluation against the predicate, rather than an evaluation with human interaction.
7. The Type of Ground Truth Used
The ground truth for the bench testing appears to be the measurements provided by the legally marketed predicate device, the Medical Graphics Ultima System (K061731). The new device's performance was compared to this established device.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This submission focuses on the performance of a medical device rather than an AI/machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, no information is provided on how its ground truth was established.
Summary of Study Information:
The study described is a bench testing comparison of the Cardiopulmonary Exercise Testing Option to Innocor against a legally marketed predicate device (Medical Graphics Ultima System, K061731). The primary goal was to demonstrate substantial equivalence in the measurement of metabolic parameters on a breath-by-breath basis. The document lacks specific details regarding quantitative performance metrics, sample sizes, data provenance, expert involvement, or adjudication methods typically associated with clinical or AI algorithm validation studies. The ground truth for this comparison was established by the measurements of the predicate device.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).