(222 days)
Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals.
Not intended for home use. Intended for use by health care professionals.
The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Patient Information Center (PIC) iX.
This 510(k) clearance letter pertains to the Philips Telemetry Monitor 5500 Release 4.0. The provided document focuses on demonstrating substantial equivalence to a predicate device and includes information regarding performance testing against established standards. However, it does not contain specific details about acceptance criteria for particular performance metrics, nor does it describe studies proving the device meets those specific acceptance criteria in the format often associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).
Instead, the document primarily cites compliance with general medical device standards and internal testing to support its claims of performance. Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific minimum sensitivity or accuracy percentage). Instead, it states that the device was assessed for conformity with relevant standards and that "results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."
| Performance Metric | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| SpO₂ Accuracy | Range between ± 1-3 % for measurements between 70-100 % SpO₂ (implied by predicate, identical claim for subject device) | Accuracy claims (results) are sensor specific and range between ± 1-3 % for measurements between 70-100 % SpO₂. |
| Electrical Safety | Conformity with IEC 60601-1 Edition 3.2 2020-08 | Found to comply |
| EMC | Conformity with ANSI AAMI IEC 60601-1-2:2014 [Including AMD1:2021] | Found to comply |
| Usability | Conformity with IEC 60601-1-6 Edition 3.2 2020-07 and ANSI AAMI IEC 62366-1:2015+AMD1:2020 | Found to comply; Summative usability testing has shown that the performance of the subject device does not raise questions of safety and effectiveness relative to the predicate device. |
| Alarm Systems | Conformity with ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] | Found to comply |
| ECG Monitoring Equipment | Conformity with ANSI AAMI IEC 60601-2-27:2011(R) 2016/IEC 60601-2-27:2011-03 | Found to comply |
| Multifunction Patient Monitoring | Conformity with IEC 80601-2-49 | Found to comply |
| Pulse Oximeter Equipment | Conformity with ISO 80601-2-61 Second edition 2017-12 | Found to comply |
| Software Life Cycle Processes | Conformity with ANSI AAMI IEC 62304:2006/A1:2016 and FDA's Guidance "Content of Premarket Submissions for Device Software Functions" | Development and testing conducted in accordance with these standards/guidance. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for any specific performance metric beyond general statements of testing compliance. For the "Clinical Studies" section related to SpO2 accuracy, it only notes that studies were conducted to "support accuracy performance" and "meet the acceptance criteria laid out in the associated protocols." No sample size for patients or data points is provided.
- Data Provenance: Not specified. The document mentions "Philips conducted clinical studies" but does not detail the country of origin of the data or whether it was retrospective or prospective.
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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 document describes performance testing against established standards and internal "accuracy specifications". For the SpO2 accuracy claims, ground truth would typically be established by invasive measurements (e.g., CO-oximetry of arterial blood samples), not by expert review of device output. The document does not provide details on how ground truth was established for the clinical studies supporting SpO2 accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Specified. Since expert review for ground truth is not indicated, adjudication methods are not relevant in the context described.
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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 provided text does not mention any MRMC comparative effectiveness study. This device is a telemetry monitor for physiological parameters, not an AI-assisted diagnostic tool for human readers. "Summative usability testing" was done, indicating human interaction with the device, but not in a comparative effectiveness study involving AI assistance for human "readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone algorithm performance is implied for certain functions, but not detailed. The device uses "Philips proprietary monitoring algorithms for ECG arrhythmia monitoring" (EASI, Hexad, ST/AR Arrhythmia Monitoring, ST/AR ST Analysis Algorithm, ST/AR QT/QTc Interval Monitoring). The performance of these algorithms would constitute "standalone" performance, but the document only states "Functional and system level testing... was performed. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards." No specific performance metrics for these algorithms are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for all performance metrics.
- For SpO₂ accuracy, ground truth is typically established by comparing the device's SpO₂ readings to invasive arterial blood gas analysis (CO-oximetry). The document only states "Philips conducted clinical studies... to support accuracy performance."
- For other performance metrics related to compliance with standards (e.g., electrical safety, EMC, usability), the "ground truth" is adherence to the standard's requirements, demonstrated through specific tests.
- Not explicitly stated for all performance metrics.
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The sample size for the training set
- Not Applicable/Not Specified. The document mentions "Philips proprietary monitoring algorithms," which would have been developed using training data. However, the size or nature of any training set is not disclosed in this 510(k) summary, as it's not a primary requirement for demonstrating substantial equivalence for this type of device.
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How the ground truth for the training set was established
- Not Applicable/Not Specified. The document does not provide information on how the ground truth for any potential training sets used in the development of "Philips proprietary monitoring algorithms" was established.
§ 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.