(48 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*.
Philips Medical Systems, M1275B Component Compact Monitor, Release A.04, with M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module. The modification is updated software and the ability to support the Philips M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module as well as the M2385A Application Server.
The provided 510(k) summary focuses on the Philips Medical Systems, M1275B Component Compact Monitor. However, the document does not contain explicit acceptance criteria tables or detailed study results demonstrating the device's performance against specific metrics.
Instead, the submission states that:
- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate."
- "Testing involved system level tests, performance tests, and safety testing from hazard analysis."
- "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."
- "The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims."
This indicates that internal testing was conducted to ensure the device met the established specifications of its predicate devices, but the specific numerical acceptance criteria and reported performance values are not disclosed in this summary.
Given the information provided, it's not possible to populate the requested table comprehensively or answer all specific questions about a detailed performance study with quantitative results, as the provided text only refers to the existence of such testing and its conclusion of substantial equivalence.
However, based on the general statements and the context of a 510(k) submission, we can infer some information:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies that the device was expected to perform at least as well as the predicate devices across all measured parameters (e.g., accuracy of gas analysis, arrhythmia detection, blood pressure measurement, ECG performance). The "reported device performance" is simply stated as meeting "all reliability requirements and performance claims" and demonstrating "substantial equivalence" to the predicate.
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Sample Size and Data Provenance: Not specified in the document. The testing described is internal verification and validation, likely conducted by the manufacturer.
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Number of Experts and Qualifications: Not specified. This type of expert review is typically not required for the technical performance testing of a multi-parameter monitor unless a specific component (e.g., arrhythmia detection algorithm) involved subjective interpretation, which is not detailed here.
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Adjudication Method: Not applicable. The testing described is objective performance and safety testing against predefined specifications, not subjective reviews requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned and typically not applicable for this type of medical device (a multi-parameter monitor). MRMC studies are common for diagnostic imaging algorithms to assess human-AI interaction.
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Standalone Performance: Yes, the described "system level tests, performance tests, and safety testing" refer to the standalone performance of the device without human interaction being part of the performance metric itself.
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Type of Ground Truth: The ground truth for this type of device would be objective, established reference standards for physiological measurements (e.g., calibrated gas mixtures for gas analyzers, known signal generators for ECG and arrhythmia detection, calibrated blood pressure cuffs for NBP, etc.). The document doesn't explicitly state the specific ground truth methodologies.
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Sample Size for Training Set: Not applicable. This device is a physiological monitor, not an AI/ML-based diagnostic algorithm that learns from a training set in the way a deep learning model would. The "software update" mentioned is more likely a traditional software update rather than a new AI model.
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How Ground Truth for Training Set was Established: Not applicable as there is no specific "training set" for an AI/ML model described.
In summary of what can be extracted from the provided text:
While detailed quantitative data is absent, the submission asserts that the Philips M1275B Component Compact Monitor underwent verification, validation, and testing activities. These tests demonstrated that its performance, functionality, and reliability were substantially equivalent to its predicate devices, meeting all established specifications and performance claims. The "Pass/Fail criteria were based on the specifications cleared for the predicate device." This constitutes the implicit acceptance criteria.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).