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The CVInsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVInsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters. Additionally, CVInsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

The CVInsight system is comprised of a cleared pulse oximeter and software application operating on a personal computer and is intended to be a non-invasive tool in the physiological monitoring of adult and pediatric patients. CVInsight wirelessly acquires and displays measures of pulse rate, functional oxygen saturation of arterial hemoglobin (SpO2), and provides alarm functionality for these parameters. CVInsight provides factory default values or optional clinician determined threshold values in which triggers alarm conditions during CVInsight operation. The device calculates percentage of change from a baseline value for the pulse strength values derived from the photoelectric plethysmograph waveform and graphically displays these values over time. The device also provides event indications based upon threshold values input by the clinician. This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. The device does not report any diagnosis but provides spot-checking and trending data only. It is the clinician's responsibility to make proper decisions based upon their experience and training.

The provided submission for the CVInsight device is a Traditional 510(k) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone clinical study with detailed performance metrics and acceptance criteria in the format typically found for novel AI/ML devices.

Therefore, much of the requested information cannot be extracted directly from the provided text because it describes design verification and validation through general performance testing, not a specific clinical study with granular detail on acceptance criteria for device performance, ground truth establishment, or human reader effectiveness.

However, based on the available text, here's what can be deduced:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "All tests that were created for the CVInsight system had passing results with acceptance criteria successfully met," but it does not provide a specific table detailing the acceptance criteria or the numerical reported device performance for functional oxygen saturation (SpO2) or pulse rate accuracy.

The core of the submission emphasizes that the device does not raise new questions of safety and efficacy and is at least as safe and effective as the predicate devices. The performance testing is described in general terms, covering software, bench verification, biocompatibility, environmental testing, and a clinical simulation (usability testing).

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "a clinical simulation (usability testing)" but does not specify the sample size for a test set or the data provenance (country of origin, retrospective/prospective). Given the nature of a pulse oximeter device, the "test set" would likely refer to a cohort of human subjects on whom the oximeter was tested. This information is absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using a co-oximeter and ECG, respectively, rather than human experts.

4. Adjudication Method

Since the document does not describe the establishment of a "ground truth" by experts, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The CVInsight system is described as a medical device for measuring and displaying physiological parameters, not a diagnostic aid requiring human interpretation of images or complex data that would necessitate an MRMC study.

6. Standalone Performance Study

The submission describes "Design verification tests" and "bench verification testing" as part of "Performance Testing" which implies standalone testing of the algorithm/device. However, the document does not provide detailed results or specific metrics for these standalone tests beyond stating that "All tests...had passing results with acceptance criteria successfully met."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used in the performance testing. For pulse oximeters, the ground truth for functional oxygen saturation (SpO2) is typically established by arterial blood gas analysis with a co-oximeter, and for pulse rate by ECG. However, this level of detail is not provided.

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. The CVInsight device is based on established pulse oximetry principles and likely uses algorithms that are well-understood in the field, rather than a machine learning model that requires a distinct training phase with a large dataset.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth was established.

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