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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.

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.

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The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The provided text is a 510(k) Special Summary for the Medgraphics Express Series, an Oxygen Uptake Computer. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel AI device might.

Based on the provided text, here's an analysis of the information requested. Many fields will be marked "Not Applicable" or "Not Provided" because the document is a summary for a traditional medical device (an oxygen uptake computer) and not an AI/ML device, and thus doesn't include the type of detailed study information typically found in submissions for AI products.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 10 systems (for laboratory and clinical testing).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal "Laboratory and clinical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/Not provided. The ground truth appears to be established by comparison to the predicate device's output, not by expert interpretation.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The study compares a new device's measurements to a predicate device's measurements, not human interpretations requiring adjudication.

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

• MRMC Study: No. This is not an AI device, and the study design is not an MRMC study.

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

• Standalone Performance: Yes, in the sense that the device itself (the Express Series) was tested against the predicate device (Ultima System) in a "tandem gas exchange system validator studies." This evaluates the device's measurement capabilities directly.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this substantial equivalence study is the performance and data output of the predicate device, the Medgraphics Ultima System (K061731). The study aimed to show that the new device's measurements (VO2, VCO2, tidal volume) had less than 5% variability when compared to the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device, so there isn't a "training set" in that sense. The device is a measurement system.

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

• Ground Truth for Training Set Establishment: Not applicable/Not provided.

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