(57 days)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are 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 Predictive Temperature measurement is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only. 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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP5 and MP5SC, that consist of display units including built-in and central processing units (CPU) and physiological measurements. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive etc., generate alarms, record physiological pressure, signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification introduces the optional The Philips Tympanic Temperature Module (866149) for the IntelliVue Patient Monitors MP5 and MP5SC. This Tympanic Temperature extends the capability of the IntelliVue Patient Module Monitors MP5 and MP5SC to interface the Genius™ 2 Tympanic Temperature Probe (cleared by Covidien, K060649). Additionally the software revision J.21 is made available for the IntelliVue Patient Monitors MP5 and MP5SC.
The provided text is a 510(k) summary for a patient monitor and mainly focuses on showing substantial equivalence to previously cleared devices. It does not contain the kind of detailed study information (like sample sizes for test and training sets, data provenance, expert qualifications, ground truth establishment, or specific performance metrics with acceptance criteria) that would typically be associated with performance studies for AI/ML devices.
The document discusses "Verification & Validation Activities" but these primarily reference compliance with general safety and EMC standards (IEC 60601-1-2 and IEC 60601-1), environmental testing, and software functionality testing. These tests confirm the device works safely and to specifications, but they don't involve the kind of performance metrics against ground truth that your questions imply for AI/ML models.
The "acceptance criteria" discussed are largely implicit: that the device works safely, effectively, and correctly in accordance with specifications and labeling claims, and that all applicable requirements of the standards are met. "Reported device performance" is also general, stating it "worked safely and according to their specifications" and "met all reliability requirements and performance claims."
Therefore, based on the provided text, I cannot complete the requested tables and information for most of your points. This document is a regulatory submission for a patient monitor with an added temperature module and software update, not a clinical performance study for an AI/ML diagnostic or prognostic device.
If this were a document for an AI/ML device, the detailed information you requested would be crucial. Since it's not, I can only address what is present in the text.
Here's an attempt to answer the questions based only on the provided text, with many fields explicitly stated as "Not Applicable" or "Not Provided" due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implicit from Text) | Reported Device Performance (from Text) |
|---|---|
| Compliance with IEC 60601-1-2:2001 +A1:2004 (EMC) | "All applicable requirements have been met." |
| Compliance with IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) | "All applicable requirements have been met." |
| Withstand Environmental Testing (temperature, humidity, shock, vibration, free fall) | "All specified test requirements have been met. The tests confirmed that the IntelliVue Patient Monitors MP5 and MP5SC worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage." |
| Software Functionality and Hazard Analysis requirements met | "All specified criteria have been met. The tests demonstrated that the IntelliVue Patient Monitors MP5 and MP5SC worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use." |
| Performance and reliability characteristics align with predicate devices | "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate... test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitors MP5 and MP5SC meet all reliability requirements and performance claims." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided. The document describes engineering and system-level verification and validation, not a clinical trial with a "test set" in the context of AI/ML performance evaluation.
- Data Provenance (country of origin, retrospective/prospective): Not provided.
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)
- Not applicable. The "ground truth" for this monitoring device is its adherence to technical specifications, safety standards, and functional claims, not expert-labeled clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described.
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
- Not applicable. This is not an AI/ML diagnostic or prognostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a patient monitor, not an algorithm being evaluated for standalone performance in the context of AI/ML. Its performance is inherent in its operation (e.g., accuracy of parameter measurement, alarm functionality).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device appears to be defined by its engineering specifications, adherence to recognized consensus standards (like IEC 60601), and functional requirements for safety and effectiveness.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document does not describe an AI/ML model or a training set.
§ 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.