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The DINAMAP® Pro Series 110-410 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

The DINAMAP Pro Series 110-410 Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

• DINAMAP 110: Non-Invasive Blood Pressure and Pulse Rate
• DINAMAP 210: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
• DINAMAP 310M: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry
• DINAMAP 410M: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry . and Temperature.
  This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

The provided document is a 510(k) Premarket Notification for the DINAMAP® Pro Series 110-410 Monitor. This document is primarily focused on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a clinical study with acceptance criteria and device performance as typically expected for complex AI/ML devices.

However, based on the information provided, here's what can be extracted and what is NOT available:

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

The document mentions several "bench studies" for safety and effectiveness, but it doesn't provide specific acceptance criteria values or the quantitative results of these tests for the DINAMAP Pro Series 110-410 Monitor itself. Instead, it relies on the substantial equivalence to predicate devices and the transfer of existing, proven technologies.

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 document. The document primarily refers to "bench studies" and "wholly implemented" technologies from predicate devices. There is no mention of a clinical test set with patient data.

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 provided as there is no description of a clinical study involving experts establishing ground truth. The device is a physiological monitor, where the "ground truth" for its measurements (e.g., blood pressure, temperature, SpO2) would typically be established through comparison with a reference standard (e.g., invasive blood pressure, rectal thermometer, co-oximetry), not via expert consensus on an image or diagnostic data.

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

This information is not provided. There is no description of a test set requiring adjudication.

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 is not applicable to this device. The DINAMAP® Pro Series 110-410 Monitor is a vital signs monitor, not a diagnostic imaging device that involves human readers or AI assistance in interpretation. The "AI" mentioned in the input query 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 itself is a standalone vital signs monitor. Its "performance" is its ability to accurately measure physiological parameters. The document states that the NIBP ASAP algorithm, Alaris IVAC Turbo thermometry, and Masimo SpO2 SET technologies were "wholly implemented" from predicate devices. This implies that the algorithms, as part of the integrated system, operate without human-in-the-loop performance for the measurement itself, though healthcare professionals interpret and act on the displayed values. However, no specific standalone performance study results for these specific integrated components of the 110-410 monitor are provided beyond the statement of implementation.

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

For the underlying technologies (NIBP, temperature, SpO2), the ground truth would typically be established by a universally accepted reference standard for each parameter (e.g., arterial catheter for NIBP, highly accurate thermometer for temperature, co-oximeter for SpO2). However, this document does not describe how the ground truth was established for the development or validation of the implemented technologies for the 110-410 monitor, as it relies on the predicate devices' prior approvals.

8. The sample size for the training set

This information is not provided. The document makes no mention of a training set as it describes the integration of existing, proven technologies rather than the development of entirely new algorithms for this specific device.

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

This information is not provided, as there is no mention of a training set.

In summary, the provided document is a regulatory submission for a vital signs monitor based on substantial equivalence. It describes the integration of existing, proven technologies but does not detail the specific performance studies, acceptance criteria, or ground truth establishment processes for these technologies as applied to the new device, instead leveraging the prior approvals of the predicate devices.

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