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The Trio™ monitor is intended for hospital use under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.

Mindray Bio-Medical Co. Ltd., previously known as Caymans Mindray Medical Electronic Company of Shenzen, China, manufactures the Trio monitor for Datascope Corp.

The Trio monitor is a three or four trace patient monitor that can be mounted on a rolling stand, wall mount bracket, bed rail, or operated as a tabletop device. The patient parameters that can be monitored on the Trio are: ECG (3-lead or 5- lead selectable), Temperature, SpO2, Invasive Blood Pressure, Respiration and Non-Invasive Blood Pressure. Digital displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non- Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure (optional) and Temperature. Waveform displays are provided for ECG, built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information.

The provided document is a 510(k) summary for the Datascope Corp. "Trio Monitor," a physiological patient monitor. It describes the device, its intended use, classification, and the predicate device. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria to the level of granularity requested in some of your questions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems Dash 2000 Pro Patient Monitor) based on the "same functional technology" and a summary of development activities like performance testing and validation. It states a "conclusion" that "The results of these measurements demonstrated that the Trio monitor is as safe, as effective and performs as well as the predicate device," but without detailing what those "measurements" were, what the specific acceptance criteria were, or the performance outcomes.

Therefore, many of your questions cannot be answered from the provided text. I will indicate where information is not available.

Here's a breakdown of the available and missing information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "The Trio monitor complies with the voluntary standards identified in section six of this submission" and that "Performance testing" was completed, but it does not list specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity for individual parameters) or the quantitative results of these tests for the Trio Monitor itself. It only concludes that it performs "as well as the predicate device."

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

Not available in the provided document. There is no information regarding the sample size of any test sets or the provenance (country, retrospective/prospective) of data used for validation.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable/Not available. Since the specific performance tests and ground truth establishment methodology are not detailed, information about experts and their qualifications for establishing ground truth is not present. This device is a physiological monitor, not typically an AI diagnostic algorithm, so "experts" in the context of ground truth for a diagnostic AI study might not be directly relevant here. For physiological monitors, performance is usually assessed against independently validated reference measurements (e.g., arterial line for NIBP, calibrated thermometers for temperature).

4. Adjudication Method for the Test Set

Not applicable/Not available. As above, without details of specific test sets and ground truth establishment, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not specified. The document does not mention an MRMC study. This type of study is more common for diagnostic imaging AI rather than a physiological patient monitor. The focus here is on the technical performance of the device itself, not necessarily on human interpretation of its outputs.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The context of a physiological monitor suggests that its performance would be evaluated in a standalone manner (device measuring physiological parameters) rather than with a human-in-the-loop for interpreting its direct outputs like heart rate or SpO2 values. However, the exact methodology of this "standalone" testing is not detailed.

7. The Type of Ground Truth Used

Not available in the provided document. While it implies that "measurements" were taken to demonstrate performance, the specific types of ground truth (e.g., comparison to gold standard reference devices, clinical outcomes) used for each monitored parameter (ECG, NIBP, SpO2, Temp, Respiration, etc.) are not described.

8. The Sample Size for the Training Set

Not applicable/Not available. This device predates the widespread use of sophisticated machine learning/AI models that require "training sets" in the modern sense. The "Trio monitor employs the same functional technology as the predicate device," suggesting traditional signal processing and algorithms, not a learning-based system with a training phase.

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

Not applicable/Not available. As explained in point 8, the concept of a "training set" for an AI algorithm is not relevant to the information provided for this device.

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