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The Trio™ monitor is intended for use in healthcare settings 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, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), 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

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This document is a marketing authorization from the FDA for a medical device called "Trio Monitor." It does not contain information about the device's acceptance criteria or the study that proves the device meets those criteria. The provided text is purely regulatory and addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market. It does not include performance data, test designs, or information about ground truth establishment.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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The Trio™ monitor is intended for use in healthcare settings 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, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), 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

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, Pleth, Invasive Blood Pressure (optional) and Respiration. The optional built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information.

The provided text for K041907 focuses on establishing substantial equivalence for the Trio Monitor, particularly regarding its expanded capability to derive Heart Rate from Non-Invasive Blood Pressure (NIBP). While it mentions testing, it does not offer the detailed acceptance criteria and study results in the structured format requested. The document primarily references previous submissions and states that the device is "as safe, as effective and performs as well, as the predicate devices."

Therefore, I cannot fulfill all sections of your request based solely on the provided text. I will, however, extract what information is present and indicate where details are missing.

Acceptance Criteria and Study for K041907 (Trio Monitor - NIBP Derived Heart Rate)

The provided submission does not explicitly state detailed, quantitative acceptance criteria or present a full study report with specific performance metrics for the NIBP-derived heart rate functionality. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to voluntary standards.

The document indicates that testing and documentation related to the ability of the Trio monitor to derive Heart Rate from Non-Invasive Blood Pressure were included in sections five, seven, and eight of the original 510(k) submission K032338, as well as in the current submission. However, these sections are not provided in the input text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission states that "The results of these measurements demonstrated that the Trio monitor is as safe, as effective and performs as well, as the predicate devices." This is a general statement of equivalency rather than specific numerical performance data or explicit acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. This would typically include information about the patient population, site of data collection (e.g., country of origin), and whether the data was collected retrospectively or prospectively.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, this type of study is not relevant for a physiological monitoring device that produces objective measurements like heart rate. MRMC studies are typically used to evaluate diagnostic imaging algorithms where human readers interpret images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

• Standalone Study: Yes, the evaluation of the NIBP-derived Heart Rate would inherently be a standalone performance assessment of the algorithm against a reference standard (e.g., ECG-derived Heart Rate). However, specific details of this study (e.g., its design, results) are not provided in the text. The statement "The ability to derive Heart Rate from the Non-Invasive Blood Pressure parameter is the subject of this 510(k) submission" and "Testing and documentation, related to the ability of the Trio monitor to derive Heart Rate from Non-Invasive Blood Pressure, is included in this 510(k) submission" implies such benchmarking was performed algorithmically.

7. The Type of Ground Truth Used

• Type of Ground Truth: While not explicitly stated, for a physiological parameter like heart rate derived from NIBP, the ground truth would most likely be a well-established and highly accurate reference method, such as Heart Rate derived from Electrocardiogram (ECG). The document mentions that in the previous submission, heart rate was derived from ECG and SpO2, suggesting ECG as a primary reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided text. The document refers to "development process" and "testing and documentation," but does not detail the training set used for the NIBP-derived heart rate algorithm if machine learning was involved in its development. However, NIBP-derived heart rate typically relies on signal processing algorithms rather than complex machine learning models requiring large "training sets" in the modern AI sense.

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

• Ground Truth for Training Set: Not specified. If the algorithm is based on signal processing principles rather than machine learning, a "ground truth for a training set" in the typical sense would not be applicable. The algorithm would be built upon known physiological relationships and signal characteristics where fundamental reference measurements (like those from ECG) are implicitly the gold standard.

In summary, the provided document K041907 serves as a 510(k) summary for a modification, referencing a previous submission (K032338). It states that testing was performed to demonstrate the safety and effectiveness of the NIBP-derived heart rate, concluding that it performs "as well as predicate devices." However, it lacks the detailed quantitative data, sample sizes, and methodological specifics typically found in full study reports when evaluating novel algorithms or device performance against explicit acceptance criteria.

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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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