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The DINAMAP® ProCare Series 100N-400N 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 ProCare Series 100N-400N 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:

• DPC 100N: Non-Invasive Blood Pressure and Pulse Rate .
• DPC 200N: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
• DPC 300N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry .
• DPC 400N: 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) summary for the DINAMAP® ProCare Series 100N-400N Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving specific acceptance criteria in the manner requested (e.g., using a test set, ground truth experts, MRMC studies, or standalone algorithm performance).

The "Testing" section (I) states that "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series 100N-400N Monitor." These studies are listed as:

• Electromagnetic Compatibility
• Electrical Safety
• Mechanical and Environmental

These types of studies typically involve engineering or regulatory compliance testing against pre-defined standards, not clinical performance evaluation with a test set of patient data, ground truth, or expert review as would be relevant for AI/software-as-a-medical-device (SaMD) clearances.

The document emphasizes that the device has the "same technological characteristics as the predicate device" and that "There are no new technologies used" (Section G). Specifically, for the key physiological parameters, it states:

• NIBP algorithm as implemented on the ProCare Series Monitor (predicate device)
• Alaris IVAC Turbo thermometry technology as implemented on the ProCare Series Monitor (predicate device)
• Wholly implemented Nellcor N-595 SpO2 technology (predicate device)

This indicates that the performance of these technologies relies on the clearance of the existing predicate devices rather than new performance studies for this specific submission.

Therefore, it is not possible to provide the requested information because the document does not describe the kind of study that would typically generate such data for a device with potentially new algorithms or performance claims. The submission is based on substantial equivalence to existing technologies and components.

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The DINAMAP® ProCare Series 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 oxygen saturation (pulse oximetry) and/or temperature. 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 ProCare Series 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:

• DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
• DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
• . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
• DPC XXX: 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 GE Medical Systems Information Technologies DINAMAP® ProCare Series Monitor relies on substantial equivalence to predicate devices rather than a standalone study demonstrating specific acceptance criteria. This means the device is deemed safe and effective because it operates with the same underlying technology and performs comparably to devices already legally marketed.

Here's an breakdown based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics for the DINAMAP® ProCare Series Monitor in a specific table. Instead, it relies on the "substantial equivalence" of its underlying technologies to predicate devices. The study proving the device meets "acceptance criteria" (implicitly, the performance of the predicate devices) is primarily based on:

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

The document does not mention a "test set" in the context of human patient data with a specific sample size. The testing primarily involved bench studies to confirm adherence to engineering and performance standards (e.g., AAMI/ANSI SP10, mechanical, electrical safety).

There is no information provided on the country of origin of data or whether the data was retrospective or prospective as no human patient data test set is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since there isn't a described "test set" and a process of establishing ground truth with experts in the human data sense, this information is not applicable and therefore not provided in the document.

4. Adjudication Method for the Test Set

As there is no described test set involving human data and expert review, an adjudication method is not applicable and not mentioned.

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

No MRMC comparative effectiveness study is mentioned. The device's approval is based on substantial equivalence to predicate devices and bench testing, not on human reader performance improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The NIBP algorithm is stated to be "wholly implemented from the DINAMAP Pro Series 100-400 Monitor or an NIBP auscultatory algorithm tested according to the ANSI/AAMI SP10 standard." The Masimo SpO2 and Alaris thermometry technologies are also "wholly implemented." This indicates that the algorithms themselves were likely evaluated in a standalone manner as part of the predicate device's original testing and by adherence to standards like ANSI/AAMI SP10 for NIBP. However, a dedicated standalone study for this specific device with performance metrics is not detailed beyond the statement of implementation and standard adherence.

7. Type of Ground Truth Used

The "ground truth" for the performance of the NIBP algorithm, for example, would have been established historically for the predicate devices or by the ANSI/AAMI SP10 standard, which specifies requirements for accuracy of non-invasive blood pressure monitors. For SpO2 and temperature, the "ground truth" would be inherent in the established performance and accuracy of the "wholly implemented" Masimo and Alaris technologies, respectively, likely validated by their own regulatory submissions. This would primarily be objective measurements against established reference methods or standards, rather than expert consensus, pathology, or outcomes data in the context of this submission.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The device relies on established algorithms from predicate devices (DINAMAP Pro Series 100-400 for NIBP, Masimo for SpO2, Alaris for Temperature). Therefore, information on a training set size is not applicable.

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

Since there is no described "training set" for a new machine learning algorithm, how its ground truth was established is not applicable. The ground truth for the underlying algorithms would have been established during the development and validation of the predicate devices or the implemented technologies (Masimo, Alaris) using methods appropriate for physiological measurements (e.g., comparison to invasive gold standards for BP, co-oximetry for SpO2, calibrated thermometers for temperature).

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