(110 days)
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.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and which are mainly free from cardiac arrhythmia.
The PPV measurement is validated for use with adult patients only.
The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature, invasive blood pressure and cardiac output) 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 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 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 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 body locations, depending on the actual physiological parameters monitored.
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 modification that is subject of this Premarket Notification adds the derived measurement PPV (pulse pressure variation), which is calculated from beat-to-beat arterial pressure values.
The Microstream Extension 867041 adds to the dedicated host device (IntelliVue Patient Monitor or Multi-Measurement Module) physiological measurements: Microstream CO2, and optionally dual invasive pressure and temperature.
The measurement extension is not a stand-alone device; it can only function when it is connected to a dedicated host device.
The modified Microstream Extension now provides the additional optional measurement cardiac output to the host devices.
The provided text contains information about the Philips IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, and IntelliVue Microstream Extension 867041. However, it does not contain specific acceptance criteria values or the results of a study designed to prove the device meets those specific criteria in the format requested, especially for performance metrics like sensitivity, specificity, or reader improvement.
The document focuses on explaining changes made to the devices (addition of PPV measurement and cardiac output measurement), demonstrating substantial equivalence to predicate devices, and listing various verification and validation (V&V) activities performed. These V&V activities generally ensure the device functions as intended and meets safety standards, rather than providing specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy.
Therefore, I cannot populate the table and answer all questions in the requested format based on the provided text.
Here's what can be extracted and what information is missing:
Missing Information (Crucial for the Request):
- Specific Acceptance Criteria Values: The document mentions that "All applicable requirements have been met" and "All specified pass/fail criteria have been met," but it does not specify what those numerical criteria are for the derived measurements (PPV, Cardiac Output accuracy, etc.). For instance, it doesn't say "PPV accuracy must be within X%" or "Cardiac Output repeatability must be less than Y%."
- Reported Device Performance: Due to the absence of specific acceptance criteria, corresponding reported device performance values are also not explicitly stated in a quantifiable manner for diagnostic type performance. It states "The modified devices perform according to the specified criteria," but the numerical results are not provided.
- Sample Size for Test Set: Not mentioned for any performance-related tests involving patient data.
- Data Provenance (Country, Retrospective/Prospective): Not mentioned.
- Number of Experts for Ground Truth: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Study: No mention of an MRMC study or AI assistance. The devices are patient monitors, not AI diagnostic tools that typically involve human readers interpreting images with or without AI assistance.
- Standalone Performance: The performance testing mentioned ("Verification of PPV calculation by comparison to predicate device", "Verification of accuracy and repeatability for right heart measurement" etc.) relates to the device's accuracy in measuring physiological parameters, which is inherently standalone measurement performance. However, specific quantifiable results are not provided.
- Type of Ground Truth: For the "Performance testing of derived measurement PPV" and "Performance testing of Cardiac Output (C.O.)", the ground truth seems to be established against the predicate device's performance or standard measurement techniques. For example, "Verification of PPV calculation by comparison to predicate device."
- Sample Size for Training Set: Not applicable as this is a patient monitor, not an AI or machine learning model that would typically have a separate "training set" in the diagnostic sense.
- How Ground Truth for Training Set was Established: Not applicable.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| For IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3: | |
| Meet requirements of AAMI ANSI IEC 62304:2006 (Software life cycle processes) | All applicable requirements have been met. |
| Meet requirements of IEC 60601-2-34: 2011 (Ed. 3) (Invasive blood pressure monitoring equipment) | All applicable requirements have been met. |
| Meet Hazard Analysis pass/fail criteria | All specified pass/fail criteria have been met. The test results confirmed the effectiveness of implemented design risk mitigation measures. |
| Functional unit level tests for Derived Measurement PPV | The modified devices perform according to the specified criteria. |
| Functional system level tests for Derived Measurement PPV | The modified devices perform according to the specified criteria. |
| Regression Tests for unchanged host monitors | All specified test requirements have been met. Test results demonstrate that modified and previously available device functions work correctly according to specifications and labeling claims. |
| Verification of PPV calculation by comparison to predicate device | All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Verification of PPV artifact detection mechanism | All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Verification of calculation of the average PPV | All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| For IntelliVue Microstream Extension 867041: | |
| Meet requirements of AAMI ANSI IEC 62304:2006 (Software life cycle processes) | All applicable requirements have been met. |
| Meet requirements of AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Basic safety and essential performance) | All applicable requirements have been met. |
| Meet requirements of IEC 60601-1-2: 2007 (Ed. 3) (Electromagnetic Compatibility) | All applicable requirements have been met. |
| Meet Hazard Analysis pass/fail criteria | All specified pass/fail criteria have been met. Test results confirmed the effectiveness of implemented design risk mitigation measures. |
| Meet Additional environmental testing (temperature, humidity) and mechanical testing (mechanical classes 7M1, 7M2, 7M3, and disinfectant resistance) | All specified test requirements have been met. Tests confirmed modified devices work safely and according to specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, disinfection, and storage. |
| Functional system level tests for Cardiac Output (C.O.) measurement | The modified devices perform according to the specified criteria. |
| Regression Tests for unchanged host monitors and other measurements in Microstream Extension 867041 | All specified test requirements have been met. Test results demonstrate that modified and previously available device functions work correctly according to specifications and labeling claims. |
| Verification of accuracy and repeatability for right heart measurement | All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Verification of accuracy and repeatability for transpulmonary measurement | All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Verification of the visibility of Thermodilution Curve in Cardiac Output Application Window | All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Verification of temperature drift limits and small signal warnings | All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices. |
| Overall substantial equivalence to predicate devices | Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates, demonstrating substantial equivalence. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the modified devices meet all defined reliability requirements and performance claims. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for any performance-related tests.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth for performance was primarily established by comparison to predicate devices or specified criteria derived from standard measurement techniques, rather than expert consensus on patient data.
4. Adjudication method for the test set:
- Not applicable/Not specified. The testing described largely involves verification against technical specifications and predicate device performance, not independent adjudication of clinical 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:
- No. The devices are patient monitors that acquire and display physiological parameters, and calculate derived measurements (PPV, Cardiac Output). They are not described as AI-assisted diagnostic tools requiring MRMC studies for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance verification of PPV calculation and Cardiac Output accuracy (e.g., "Verification of accuracy and repeatability") are tests of the device's standalone measurement capabilities. However, specific numerical results of these tests (e.g., actual accuracy percentages or repeatability values) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primarily comparison to predicate device performance and compliance with recognized consensus standards and internal specifications. For example, "Verification of PPV calculation by comparison to predicate device" and "All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices."
8. The sample size for the training set:
- Not applicable. These are patient monitoring devices with specified measurement algorithms, not machine learning models that undergo training on a "training set" in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" for AI/ML algorithms.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.