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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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