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The SureSigns VM4, VM6 and VM8 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. 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 subject devices are the Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors. They are multi-parameter patient monitors. Modifications include adding arrhythmia analysis to the VM4, adding standby mode into the CO2 menu, changing the LCD display backlight to LED, replacing the current Oridion CO2 module with a RoHS compliant module, and several enhancement requests related to display, alarms, labeling, NBP measurement, patient demographics, heart rate and pulse display, trend database size, and software hooks for connection to a central station.

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance for a modern AI/ML medical device submission. This document describes a traditional patient monitor (Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8) and its 510(k) submission from 2012-2013, which predates the widespread use of sophisticated AI/ML algorithms in medical devices in the way your prompt implies.

The 510(k) in the input describes incremental changes to an existing patient monitor, primarily focusing on:

• Adding arrhythmia analysis to a new model (VM4) using an existing software algorithm from other models (VM6, VM8). This is not a description of a novel AI/ML algorithm requiring extensive validation as commonly discussed today.
• Minor user interface enhancements and technical component changes (e.g., LED backlight, RoHS compliant CO2 module).
• Adding software hooks for future central station connection.

Therefore, the specific criteria for AI/ML performance (e.g., sensitivity, specificity, AUC) and detailed study methodologies (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, specific ground truth types) are not present in this document.

The document only states general verification and validation activities:

• "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates."
• "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, the specifications of the subject device and test results showed substantial equivalence."

This is typical for traditional hardware/software modifications.

In summary, I cannot extract the requested information because the provided document is for a traditional patient monitor 510(k) submission from 2013, not an AI/ML device, and thus does not contain the detailed performance metrics and study design methodologies specifically relevant to validating AI/ML algorithms.

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Indicated for central monitoring of multiple adult, pediatric, and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The Philips SureSigns VSV (Vital Signs Viewer) is a device for central monitoring of multiple patients. The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors.

The provided text describes a 510(k) summary for the Philips SureSigns VSV (Vital Signs Viewer) and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative sense. The summary primarily focuses on regulatory aspects, substantial equivalence, and general statements about testing.

Therefore, many of the requested details cannot be extracted from the provided input.

Here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims."

However, specific quantitative acceptance criteria (e.g., accuracy percentages, sensitivity, specificity, or error rates for arrhythmia detection) are not provided. Therefore, a table cannot be constructed with reported device performance against specific numerical criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text.

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)

This information is not provided in the text. The document refers to "verification, validation, and testing activities" but does not detail the methodology for establishing ground truth or the involvement of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text.

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

This information is not provided in the text. The device is a "Vital Signs Viewer" and "Arrhythmia Detector and Alarm," implying automated functions. The text does not mention any studies involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire submission is for a device with automated functions ("Physiological Monitor, Patient Monitor," "Arrhythmia Detector and Alarm"). The "verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." This implies a standalone assessment of the device's capabilities in detecting arrhythmias and monitoring vital signs. However, specific details of this "standalone" performance are not quantitatively reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the text.

8. The sample size for the training set

This information is not provided in the text.

9. How the ground truth for the training set was established

This information is not provided in the text.

Summary of available information:

The 510(k) summary indicates that the Philips SureSigns VSV underwent "Verification, validation, and testing activities" including "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." The "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The overall conclusion is that "Philips SureSigns Vital Signs Viewer (VSV) functionality meets all reliability requirements and performance claims."

However, critically, the document lacks specific numerical acceptance criteria and detailed quantitative performance results that would allow for a comprehensive answer to your request. The provided text is a summary statement for regulatory approval, focusing on substantial equivalence rather than a detailed scientific study report.

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