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The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital or ground transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate 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 Monitor, Series 100, 200, 300, 400 is a prescription device intended for use only by health care professionals. Four configurations of the monitor - all with an integrated printer - will offer the following vital signs parameters: . DINAMAP Pro Series 100: Non-Invasive Blood Pressure and Pulse Rate - DINAMAP Pro Series 200: Non-Invasive Blood Pressure and Monitor/Predictive Oral/Rectal . Temperature - . DINAMAP Pro Series 300: Non-Invasive Blood Pressure and Nellcor® Pulse Oximetry and Pulse Rate - . DINAMAP Pro Series 400: Non-Invasive Blood Pressure and Pulse Rate; Monitor/Predictive Oral/Rectal Temperature; and Nellcor® Oxygen Saturation and Pulse Rate (Pulse Oximetry) 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 device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97).

Here's a breakdown of the acceptance criteria and study information for the DINAMAP® Pro Monitor, Series 100, 200, 300, 400, based on the provided text:

Acceptance Criteria and Device Performance for DINAMAP® Pro Monitor

1. Table of Acceptance Criteria and Reported Device Performance

This device combines multiple physiological monitoring functionalities. The acceptance criteria and performance are detailed for each major component: Non-Invasive Blood Pressure (NIBP), Oxygen Saturation (SpO2), and Temperature.

2. Sample Size and Data Provenance

• NIBP:

  • Clinical Study for Accuracy (predicate device): The text states accuracy was established in "adult, pediatric, and neonatal populations." It references the DINAMAP MPS Select NIBP Module, but does not provide specific sample sizes for these populations in the current document.
  • Data Provenance: Not explicitly stated, but the studies were for a U.S. market device, so likely at U.S. clinical sites. The studies for the predicate device would have been prospective clinical trials.

• SpO2:

  • Co-Oximeter Correlation Study: 3 healthy subjects.
  • Non-Invasive Controlled Hypoxia Study: 35 subjects.
  • Data Provenance: Not explicitly stated, but conducted by Nellcor Puritan Bennett, Inc. (NPB), a U.S. company. Likely prospective studies.

• Temperature:

  • Clinical Study: 78 subjects (adult and pediatric).
  • Data Provenance: In-house study conducted by Critikon. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document primarily references standards (ANSI/AAMI, ASTM) and reference devices (co-oximeter, mercury-in-glass thermometer, IVAC 2080 Measurement System) for establishing ground truth, rather than human experts making subjective assessments for the purpose of algorithm validation directly.
• For NIBP, the ground truth would have been established by invasive arterial blood pressure measurements (gold standard for NIBP validation) during the predicate device trials. The document doesn't specify the number or qualifications of clinicians involved in those ground truth measurements, but it would have been standard clinical practice.
• For SpO2, arterial blood oxygen saturation co-oximeter measurements serve as the ground truth. These are objective measurements; no human experts are mentioned for establishing this ground truth.
• For Temperature, mercury-in-glass thermometers and the Alaris Medical Systems IVAC® 2080 Measurement System served as the reference standards for ground truth. Again, these are objective measurement devices, not subjective assessments by human experts.

4. Adjudication Method

• NIBP, SpO2, Temperature: The validation relies on comparisons against established objective reference standards and devices (e.g., co-oximeters, mercury thermometers, invasive BP for NIBP in predicate). Therefore, there is no mention of an adjudication method involving multiple human experts for subjective assessment as would be common in image interpretation studies. The "adjudication" is inherent in the comparison of the device reading to the objective reference standard.

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

• No, a MRMC comparative effectiveness study was not explicitly mentioned or performed for this device. The studies described are focused on standalone device accuracy against objective standards, not on how human readers interact with or improve using AI assistance, as this is a vital signs monitor, not an AI-driven interpretive system.

6. Standalone Performance Study

• Yes, standalone performance studies were done for all parameters.
  • NIBP: Accuracy was established for the NIBP algorithm itself, which is incorporated into the device. The clinical study for accuracy, although done on a predicate, validates the algorithm in a standalone manner.
  • SpO2: Clinical and bench tests directly evaluated the accuracy of the oxygen saturation parameter of the new device against reference standards.
  • Temperature: Both monitor and predictive modes were tested for accuracy against reference standards in liquid baths and clinically against a mercury-in-glass thermometer.

7. Type of Ground Truth Used

• NIBP: For the predicate device studies, the ground truth for NIBP accuracy would have been invasive arterial blood pressure measurements.
• SpO2: Arterial blood oxygen saturation co-oximeter measurements (objective laboratory measurements).
• Temperature: Mercury-in-glass thermometer and the Alaris Medical Systems IVAC® 2080 Measurement System (objective reference devices/standards).

8. Sample Size for the Training Set

• This device is a traditional physiological monitor, not an AI/machine learning device in the modern sense that typically relies on "training sets." The NIBP algorithm is based on established oscillometric principles. Therefore, there is no specific "training set" sample size mentioned or applicable in the context of an AI/ML model for this type of device. The algorithm and device were likely developed and refined using R&D data, but not in the format of a distinct "training set" for an AI model.

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

• As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. The underlying principles and algorithms for NIBP, SpO2, and temperature are based on well-understood physiological measurements and engineering principles, validated against established medical standards and reference measurements. Development of these algorithms would involve extensive testing and refinement against known accurate measurements, but not in a "ground truth for training set" paradigm.

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