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For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The Philips Drug Calculator Software served by the Philips IntelliVue application server software (M2387A Application Server Software). The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV drug computations in 100 mL IV bags.

The provided text describes a 510(k) premarket notification for the Philips Drug Calculator Software. However, the documentation focuses primarily on the regulatory aspects of substantial equivalence and does not contain the specific details required to answer all questions about acceptance criteria and a dedicated study proving device performance against those criteria.

Here's what can be extracted and what information is missing:

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

The document does not explicitly list acceptance criteria or specific reported device performance in a quantitative manner. It states:

• "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate."
• "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."

This indicates that internal specifications and the performance of predicate devices served as benchmarks, but the actual criteria and performance metrics are not detailed.

Missing Information for 2-9:

The provided text focuses on the 510(k) summary for the Philips Drug Calculator Software, emphasizing its substantial equivalence to previously cleared devices. It states that "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate," and that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."

However, the document does not provide the detailed information requested regarding sample sizes, data provenance, expert involvement, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set specifics. The document is a regulatory submission summary, not a detailed study report.

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