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The 506 Patient monitor interprets and displays real time physiological data of the patient. The 506 is configured to monitor Noninvasive BP (NIBP), SpO2, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor has utilized existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO2, and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar plethysmogram and numerical data. The 506 can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP), SpO2, and Temperature. For all these vital parameters, the 506 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

The provided document is a 510(k) summary for the Criticare Systems Inc. Model 506 Patient Monitor. It details the device's functionality, intended use, and its claim of substantial equivalence to a predicate device (507EL Vital Signs Monitoring System, K022435).

However, the document does not contain specific acceptance criteria, comprehensive study details, or performance data in a format that would allow for the construction of the requested table and detailed answers.

Here's a breakdown of what can be extracted and what is missing:

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

Missing. The document states:

• "The 506 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device."
• "Additionally, the 506 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed."

It lists standards like EN1060-1 NIBP Performance, EN 1060-3 NIBP Performance, AAMI SP-10 NIBP Performance, and EN 865 Oximetry Performance. However, it does not specify the numerical acceptance criteria derived from these standards or the actual performance values achieved by the 506 monitor. Without this data, a table cannot be created.

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

Missing. The document states "The patient monitoring technologies present in the 506 monitor have been in clinical use for at least six years in the 507EL monitor and it's predicates." It also mentions "CSI's field experience with these modalities in the predicate devices has been satisfactory."

While this indicates reliance on historical clinical use and field experience of predicate devices, it does not provide details about a specific test set used for the 506 monitor itself, including sample size, data provenance, or whether it was retrospective or prospective.

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)

N/A (Not Applicable) / Missing. Given that the document emphasizes performance equivalence to a predicate device and compliance with standards, and doesn't describe a specific clinical study with a distinct "test set" requiring expert ground truth establishment in the typical sense (e.g., for an AI algorithm interpreting images), this information is not present. The "ground truth" for vital sign monitors is typically derived from established measurement methods and validated reference devices, rather than expert consensus on interpretive tasks.

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

N/A (Not Applicable) / Missing. Similar to point 3, as no specific clinical test set requiring expert adjudication is described, this information is not provided.

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

N/A (Not Applicable). The 506 Patient Monitor is a vital signs monitor, not an AI-assisted diagnostic imaging device that typically involves human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

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

Yes, implicitly. The device itself is the "standalone" component in the context of its measurements. The document states its performance was "confirmed to be equivalent to the predicate device" and that it "complies with applicable safety and performance standards." This implies testing the device's accuracy in measuring parameters like NIBP, SpO2, and Temperature directly against reference methods or established standards. The measurements it provides are direct outputs, not interpretations requiring human-in-the-loop for determination of the primary output.

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

Given the nature of a vital signs monitor:

• For NIBP and SpO2: Ground truth would typically be established by comparison to a reference standard device or method (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2) in controlled human or animal studies, or simulation models, as specified by the relevant performance standards (e.g., AAMI SP-10 for NIBP, EN 865 for Oximetry).
• For Temperature: Ground truth would be provided by highly accurate reference thermometers or established methods (e.g., rectal probe for core temperature) specific to the measurement site and method.

The document refers to compliance with standards like EN1060-1, EN 1060-3, AAMI SP-10, and EN 865, which would dictate the appropriate ground truth methods for performance testing.

8. The sample size for the training set

N/A (Not Applicable) / Missing. This device is a traditional physiological monitor, not an AI/ML-based device that typically requires a "training set." The technologies utilized are described as "existing core technologies" and "in clinical use for at least six years," implying established, non-machine learning methods.

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

N/A (Not Applicable) / Missing. See point 8.

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