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The Model 6000 is intended to provide continuous noninvasive monitoring of SpO2 and EtCO2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol.

This device is intended for use on adult, geriatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments only under the direction of a physician or qualified clinician.

The device is a two parameter patient monitor. Both EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally. The device displays the waveforms and numerical values associated with each parameter on a color LCD display, and transmits the information to a network based computing device over the 802.11a - g IEEE wireless protocol. The device is intended for use on adult, geriatric, pediatric, and neonatal patients only under the direction of a physician or qualified clinician.

The provided text describes a 510(k) summary for the Ivy Biomedical Systems Model 6000 Two Parameter Bedside Monitor. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not include specific information about acceptance criteria for performance metrics (e.g., accuracy, precision for SpO2 or EtCO2) nor a dedicated study section with the detailed information requested in the prompt (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.).

The document states: "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing, and medical device safety testing. Software on the device was verified and validated according to the functionality of the operations of the device. The test results confirm that the device is in accordance with its specifications."

This summary indicates that performance and safety testing were conducted internally, aligning with various industrial and medical device standards (UL 60601-1, IEC 60601-1-2, etc.). However, it does not explicitly state the quantitative acceptance criteria for SpO2 and EtCO2 accuracy, nor does it present the results of such performance tests in a format that allows for the construction of the requested table or detailed study description.

Therefore, for many of the requested points, the information is not available in the provided text.

Here is a summary of what can and cannot be extracted from the provided text based on your prompt:

Acceptance Criteria and Study for Model 6000 Two Parameter Bedside Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document broadly states that "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. The test results confirm that the device is in accordance with its specifications." However, it does not provide specific numerical acceptance criteria or reported performance values for parameters like SpO2 or EtCO2 accuracy which would typically be included in a detailed performance study for such a device.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document implies internal testing and compliance with various international standards (UL, IEC, ISO, CAN/CSA, CISPR), but no details on clinical data collection are provided.

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

• Not applicable/Not specified. This device is a monitor measuring physiological parameters, not an diagnostic imaging or interpretation device that would typically rely on human expert consensus for ground truth on a test set. The ground truth for such devices usually involves highly accurate reference measurement equipment. However, the document does not detail how the ground truth for its performance validation (e.g., SpO2 or EtCO2 accuracy) was established.

4. Adjudication method for the test set:

• Not applicable/Not specified. Given the nature of the device (physiological monitor), an adjudication method in the context of expert review is not typically relevant as it would be for AI-driven interpretation tasks.

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:

• Not applicable/Not specified. The Model 6000 is a patient monitor, not an AI-assisted diagnostic tool that interprets data for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

• The device is a standalone monitor. Its performance would inherently be evaluated in a standalone manner, measuring its accuracy against reference standards. However, the details of such standalone performance testing (e.g., specific accuracy metrics, methodologies) are not provided in this 510(k) summary beyond the general statement of "verification and validation."

7. The type of ground truth used:

• Not specified. For physiological monitors, ground truth typically involves highly accurate, gold-standard reference devices (e.g., a CO-oximeter for SpO2, a calibrated gas analyzer for EtCO2). The document mentions that "EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally," implying these modules themselves may have established accuracy, but it doesn't detail the validation of the integrated system against an independent ground truth.

8. The sample size for the training set:

• Not applicable/Not specified. This device is a physiological monitor, not a machine learning model that requires a "training set." Its functionality is based on established engineering principles and commercially available modules, rather than learned patterns from a large dataset.

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

• Not applicable. As there's no mention of a training set for a machine learning model, this question is not relevant to the described device.

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