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Indications for Use statement for the MX100 and X3:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

Indications for Use statement for the Hemodynamic Extension 867039:

The measurement extension adds physiological measurements to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device.

The new IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and Hemodynamic Extension 867039 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The measurement sensors are applied at diverse bodily locations, depending on the actual physiological parameters monitored.

The new devices have the same range of functions as the legally marketed predicate devices. They use the same measurement parameters as the predicates.

Whereas the predicate devices optionally provide one invasive pressure, the new devices optionally provide two invasive pressures (dual pressure) that can be measured with one pressure connector.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The Hemodynamic Extension 867039 adds optional measurements: dual invasive pressure, temperature, and cardiac output /continuous cardiac output to the host device. The measurement extension can only function when it is connected to a dedicated host device.

Specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications and measurement alarm specifications, are the same as those in the predicate devices. The new devices reuse unchanged existing accessories of the predicates.

The new IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 are compact, rugged, lightweight monitors with built-in measurements. The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

The MX100 and X3 have a 6.1' TFT flat panel color display with a multi-finger touchscreen as input device.

The MX100 and X3 can interact with the Central Station via LAN or wireless link.

The new Transpac IV Dual IBP Cable 453564588501 is a reusable cable intended to connect two ICU Transpac pressure transducers with one of the new Philips measuring devices (Patient Monitor MX100, Multi-Measurement Module X3, or Hemodynamic Extension 867039). The cable transmits analog voltage signals from the pressure transducers to the Philips device and provides electrical power from the Philips device to the transducers.

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and IntelliVue Hemodynamic Extension 867039, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in a concise format. Instead, it refers to fulfilling requirements of various recognized consensus standards and device-specific guidance documents. The general statement is:

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

The document does not explicitly state the sample sizes used for various test sets in terms of patient numbers or data records.

• NIBP testing: "minimum of three devices" were compared for intra-device variability.
• Data Provenance: Not specified. The document describes a series of engineering tests and compliance to standards, rather than clinical trials with patient data.

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

This information is not provided in the document. The studies described are primarily engineering verification and validation against established standards and predicate device specifications, rather than relying on expert ground truth for patient data in the typical sense of a diagnostic AI product.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described is against defined technical specifications and standards, not a diagnostic task requiring adjudication of expert interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is a patient monitor, not an AI-assisted diagnostic tool that aids human readers in interpreting medical images or data. The focus is on the device's accuracy and reliability in measuring and displaying physiological parameters.

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

The device is inherently a "standalone" system in terms of its algorithmic performance for measuring physiological parameters. The studies described (e.g., NIBP accuracy, SpO2 accuracy, respiration rate accuracy) directly assess the device's algorithms and hardware without requiring human intervention in the measurement process itself, though it is intended for use by healthcare professionals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing appears to be based on:

• Reference Standards: For parameters like NIBP, a "comparison to the intra-arterial reference standard for mean blood pressure" was used.
• Predicate Device Specifications: The "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
• Consensus Standards: Performance was evaluated against recognized consensus standards (e.g., IEC, AAMI, ISO) which define acceptable limits for accuracy and performance.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a medical device, not a machine learning or AI model that requires a "training set" in the conventional sense. The device's algorithms are likely based on established physiological principles and engineering design, not data-driven machine learning models that are "trained."

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

This information is not applicable and not provided, as there is no mention of a "training set" for a machine learning algorithm.

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The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.

The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.

This document describes a 510(k) submission for a Disposable Pressure Transducer (DPT). The submission aims to establish substantial equivalence to a predicate device, the Transpac® Disposable Straight Pressure Transducer (DSPT) (K061573).

Here's the breakdown of the information requested, based on the provided text:

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

The provided text only states that "Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications and was substantially equivalent to the predicate device." It does not specify the actual acceptance criteria (e.g., specific accuracy ranges, drift limits, etc.) or the detailed reported performance results against those criteria. The focus of this 510(k) summary is on the conclusion of equivalence, not the granular performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for performance testing or the data provenance.

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 applicable and not provided. The device in question is a physical measurement transducer, not one requiring expert interpretation of data to establish ground truth for testing. Performance testing for such devices typically involves comparison against calibrated reference standards, not human expert consensus.

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

This information is not applicable and not provided, as the testing does not involve human interpretation or 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

No MRMC comparative effectiveness study was done. This type of study is not relevant for a disposable pressure transducer.

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

This concept is not directly applicable to a disposable pressure transducer. The performance tests would have evaluated the device's ability to accurately convert pressure into electrical signals, without human intervention in the primary measurement process itself. The "standalone" performance here refers to the device's intrinsic accuracy and reliability. The text indicates "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," which implies standalone performance evaluation.

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

The ground truth for evaluating the performance of a pressure transducer would be established using calibrated reference pressure sources and possibly traceable measurement standards. For example, a precise pressure calibrator would be used to apply known pressures, and the DPT's output would be compared against these known values. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. This device is not an AI/ML algorithm.

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