(170 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
The Philips Medical Systems MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Software Revision G.01 are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.
The Philips Medical Systems MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.01. The modification is the introduction of the new interfacing IntelliBridge EC10 and EC5 modules and the related introduction of software release G.01 for the entire IntelliVue Patient Monitors family, models MP40, MP50, MP60, MP70, MP80, and MP90.
The provided text is a 510(k) summary for the Philips Medical Systems IntelliVue Patient Monitors. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices. However, the document does not contain specific acceptance criteria, performance data, or detailed study information that would allow me to populate the requested table and answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states:
"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved at system level regression tests, safety and performance tests, EMC and environmental tests, and testing as required from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims."
This is a general statement about testing and does not provide the specific details requested. Therefore, I cannot generate the requested table and detailed answers.
Summary of missing information:
- Acceptance Criteria & Reported Performance: Not specified for any particular function or parameter. The document only states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
- Sample sizes for test set: Not mentioned.
- Data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance: Not mentioned, beyond general statements about "performance, functionality, and reliability."
- Type of ground truth used: Not specified, as no specific performance metrics are provided.
- Sample size for training set: Not applicable, as this is a traditional medical device submission, not a machine learning algorithm with explicit training/test sets as would be seen in AI/ML submissions.
- Ground truth for training set: Not applicable.
§ 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.