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The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.

The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.

The provided text describes the ORCA Cardiopulmonary Exercise Testing System and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study report with methodological details commonly found for proving such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a standalone clinical study report with detailed performance metrics. Therefore, many of the requested details are not explicitly present in the provided text.

Based on the available information, here's what can be inferred and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific, quantified acceptance criteria and a study to prove the device meets these criteria as if it were a novel device requiring de novo authorization.

The "acceptance criteria" here are implicitly related to the device having similar performance, features, and intended use as the predicate devices (MedGraphics Exercise Consult K923209 and Sensormedics Vmax 229 K942211). The "study" proving this is the 510(k) submission itself, which argues for substantial equivalence by comparing the ORCA system to these predicates.

1. A table of acceptance criteria and the reported device performance

Since the regulatory pathway is 510(k) and focuses on substantial equivalence, explicit quantitative acceptance criteria for performance metrics in a pass/fail format are not presented. Instead, the document compares the features and intended use of the ORCA system to its predicates.

Missing Information: Quantitative performance metrics (e.g., accuracy, precision, repeatability for O2/CO2 measurement, flow measurement, pulse rate measurement, or the interpretive statements' accuracy) are not provided in this 510(k) summary. The "acceptance criteria" appear to be met by demonstrating similar functionality and intended use to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe a specific clinical "test set" and study data for the ORCA system in the way a clinical trial would. The basis for equivalence is primarily a comparison of device specifications and intended use against existing, cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided by the document. The 510(k) summary does not describe a process of establishing ground truth with experts for a test set, as would be done for an AI diagnostic device requiring such validation. The interpretive statements feature is mentioned, but its validation methodology isn't detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided by the document. There is no mention of a test set requiring adjudication in this 510(k) summary.

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

This information is not applicable/not provided by the document. The ORCA system is described as generating interpretive statements, but not as an "AI assistance" device in the context of improving human reader performance via an MRMC study. It's a system to collect and analyze physiological data and provide interpretive statements based on that analysis.

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

The device is described as assisting in "collection and analysis of gas exchange and extraction of pulse rate information" and will "suggest interpretive statements." This suggests a standalone analytical component. However, specific standalone performance metrics (e.g., accuracy of interpretation) are not detailed in the provided summary. The focus is on the device as a whole system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided for any validation of the interpretive statements. For the measurements (O2, CO2, flow, pulse rate), the implied "ground truth" would likely be comparison to reference measurement devices or established calibration standards, but specifics are missing from this summary.

8. The sample size for the training set

This information is not provided. The 510(k) summary does not mention a "training set," implying that if any algorithms are used for interpretation, they are based on established physiological models or rules rather than machine learning trained on a dataset.

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

This information is not applicable/not provided. Without a mention of a training set, there's no information on how its ground truth would have been established.

In summary: The provided 510(k) document serves to demonstrate substantial equivalence based on device features and intended use, rather than a detailed performance study with explicit acceptance criteria and validation data as typically required for novel or high-risk devices or AI/ML-enabled devices today. The "study" for acceptance here is the comparison presented in the 510(k) application itself, aligning the ORCA system's attributes with those of the predicate devices.

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