(30 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: ECG, Respiration, NBP, SpO2, IBP, CO2, Temperature.
The SureSigns VM Series Patient Monitors are for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
This Philips 510(k) summary focuses on modifications to existing SureSigns Series Patient Monitors (VM4, VM6, and VM8) and does not contain detailed acceptance criteria and study results in the format requested. The document asserts substantial equivalence to previously cleared devices based on verification, validation, and testing activities.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing: The document does not provide a table of specific acceptance criteria (e.g., accuracy ranges, precision limits for each physiological parameter) or quantitative performance data (e.g., reported accuracy, bias, or standard deviation for ECG, NBP, SpO2, etc.).
- What's stated: "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." This indicates that performance was evaluated against existing specifications of predicate devices and the modified device. However, the actual specifications or results are not detailed. "The results demonstrate that the Philips SureSigns VM4, VM6 and VM8 Patient Monitors meet all reliability requirements and performance claims and supports a determination of substantial equivalence." This is a general statement of compliance, not a presentation of specific performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: The document does not specify any sample sizes for test sets (e.g., number of patients, number of measurements).
- Missing: No information on data provenance (country of origin, retrospective/prospective) is 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/Missing: This type of information is typically relevant for studies involving subjective human interpretation (e.g., image analysis, diagnosis) where expert consensus establishes ground truth. For physiological monitoring devices, the "ground truth" for parameters like heart rate, NBP, or SpO2 is typically established by reference devices (e.g., a highly accurate ECG machine, invasive blood pressure measurement, lab oximeter). The document does not describe the use of experts to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Missing: Similar to point 3, adjudication methods are relevant for subjective expert reviews. For objective physiological measurements validated against reference standards, an adjudication method in this sense is not typically used.
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/Missing: This device is a multi-parameter patient monitor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device's intended use or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Present (implicitly): The "performance tests" mentioned would likely involve standalone performance of the device's measurement algorithms against reference standards. While not explicitly detailed as "standalone algorithm performance," the validation of physiological measurements inherently tests the device's algorithms in isolation (i.e., without a human in the loop for the measurement itself, though humans operate the device).
- What's stated: "Testing involved system level tests, performance tests, and safety testing from hazard analysis." Performance tests fall under this category.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit (Reference Devices/Standards): For physiological monitors, ground truth is typically established using highly accurate, calibrated reference devices or validated physical simulators/phantoms. This document does not specify which reference devices or methods were used, but standard practice would dictate such an approach for parameters like ECG, NBP, SpO2, etc.
8. The sample size for the training set
- Not applicable/Missing: This device is not described as using machine learning requiring a training set in the conventional sense. The "modifications" described are for alarm limit ranges and indications for use, not for a new AI algorithm.
9. How the ground truth for the training set was established
- Not applicable/Missing: As there is no described "training set" for a machine learning algorithm, this question is not relevant to the provided text.
In summary:
This 510(k) summary is for a modification to an existing patient monitor, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo performance study with detailed acceptance criteria and results. The focus is on verifying that the changes (mainly to heart rate alarm ranges and parameter listings in Indications for Use) do not alter the fundamental characteristics or safety/effectiveness of the device, which is typical for modifications to already cleared devices. Therefore, much of the detailed study information you requested (e.g., sample sizes, expert involvement, MRMC studies) is either not applicable or not provided in this specific type of regulatory document.
§ 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.