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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: NBP, SpO2, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

The Philips SureSigns VS2* Vital Signs Monitor is a multi-parameter patient monitor. Standard and optional parameters include: NBP, SpO2, and Temperature. The energy source of the subject device is an internal power supply. The VS2* can run on battery power with batteries similar to the predicate device, however, with improved battery life.

The provided text is a 510(k) summary for the Philips SureSigns VS2 Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study with the kind of quantitative performance metrics, sample sizes, and expert adjudication described in the prompt. The document states that "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." However, it does not provide these specific criteria or the detailed results of the performance tests.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device". However, the specific quantitative acceptance criteria (e.g., accuracy ranges for NBP, SpO2, Temperature) are not provided.
• Reported Device Performance: The document only generically states that "The results demonstrate that the Philips SureSigns VS2* Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence." Specific performance metrics (e.g., bias, precision, accuracy) for NBP, SpO2, or Temperature are not reported.

2. Sample sized 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 document. The text mentions "system level tests, performance tests, and safety testing" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient data, simulated data).

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)

• Ground truth refers to a definitive correct answer, often established by experts in diagnostic studies. For a vital signs monitor, ground truth typically involves highly accurate reference devices. The document does not mention the use of experts or any process for establishing ground truth in terms of clinical interpretation, as it's a device measuring physiological parameters, not interpreting images or complex clinical scenarios requiring expert consensus.

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

• Adjudication methods are relevant when multiple experts rate the same case and their opinions need to be reconciled. As no expert review or interpretation is described for the performance testing of this vital signs monitor, this information is not applicable/provided.

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

• An MRMC study is relevant for diagnostic devices that aid medical professionals in interpretation. This device is a vital signs monitor, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, an MRMC study and related effect sizes are not applicable and not mentioned.

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

• The device itself is a standalone monitor. The performance testing would inherently be the "algorithm only" performance (i.e., the device's ability to accurately measure vital signs). The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device," implying standalone testing. However, specific details of this testing are not provided.

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

• For a vital signs monitor, ground truth typically refers to measurements obtained from highly accurate, calibrated reference devices (e.g., a reference NBP device, a co-oximeter for SpO2, a highly accurate thermometer). The document does not explicitly state the type of ground truth used for its performance testing, but it would logically be comparison to independent reference measurements.

8. The sample size for the training set

• This device is a hardware vital signs monitor. While it has embedded software/firmware (which might have been "trained" or developed), the concept of a "training set" as understood in machine learning/AI is likely not directly applicable in the same way. The document makes no mention of a training set.

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

• Similar to point 8, the concept of a "training set" and its ground truth in the context of this traditional medical device is not applicable/provided.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

The SureSigns VS2 Vital Signs monitor and the SureSigns VM1 are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility. The addition of the wireless functionality to the predicate VS3 does not change the intended use or indications for use. The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design as the predict device. The composition of the VS2 and the VM1 materials are different than the predicate device, however are made of a material previously used in other medical devices. The chemical composition of the subject devices has changed but is the same as material used in other predicate devices. The energy source of the subject device the VS2 is an external power supply, while the VM1 will use a power supply that is the same as the predicate device. The VS2 and the VM1 both can run on battery power with batteries similar to the predicate devices.

The provided 510(k) summary for the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs Monitor does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets specific acceptance criteria in the way typically expected for AI/ML device evaluations.

This document is a pre-market notification (510(k)) for physiological monitoring devices, specifically patient monitors, and their modifications. The evaluation for substantial equivalence in such devices often focuses on comparing technical characteristics and performance to legally marketed predicate devices, rather than establishing novel performance metrics against a defined ground truth using a clinical study with a specified sample size and expert review in the context of an algorithm.

Here's a breakdown of what can be extracted and what is missing:

The document states:
"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. The results demonstrate that the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs monitor and the modification to the SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."

This indicates that the "acceptance criteria" were essentially the specifications of the predicate device and the subject device, and the "study" was system-level, performance, and safety testing aimed at demonstrating substantial equivalence. However, specific numerical performance metrics are not provided in this summary.

Therefore, many parts of your request cannot be directly answered from the provided text.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not give a sample size of patients or data records.
• Data Provenance: Not specified. It's likely these tests were conducted internally by Philips Medical Systems (Andover, MA, United States), but the origin of any clinical data (if used) is not detailed. The distinction between retrospective or prospective data is not applicable given the type of testing described (device function/safety rather than algorithm performance on clinical data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not specified. This type of information (number and qualification of experts establishing ground truth) is typically relevant for studies evaluating an AI/ML diagnostic or prognostic system against a human standard. For a patient monitor, "ground truth" would be established by reference standards or direct physical measurements, not expert consensus on interpretations of images or signals.

4. Adjudication method for the test set

• Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth. This is not typically part of the testing for a physiological monitor's basic functions.

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 / Not done. This is a physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device's evaluation.

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

• Not applicable / Not mentioned in this context. While these devices contain algorithms for processing physiological signals (e.g., arrhythmia detection, NIBP calculation), the 510(k) summary does not describe a "standalone" algorithm performance study in the way it's typically understood for AI/ML devices where the algorithm's output is compared to a ground truth independent of human interaction. The testing described focuses on the integrated device's performance.

7. The type of ground truth used

• Likely reference standards and direct physical measurements. For physiological monitors, ground truth for parameters like blood pressure, heart rate, or SpO2 would typically involve highly accurate reference devices or invasive measurements (e.g., arterial line for blood pressure) against which the monitor's readings are compared. The document does not explicitly state this but it's the standard practice for such devices.
• Not pathology, outcomes data, or expert consensus in the context of diagnostic interpretation.

8. The sample size for the training set

• Not applicable / Not specified. These devices are not described as employing machine learning models that require a "training set" in the modern sense. They rely on established signal processing algorithms. If any adaptive algorithms or calibrations exist, the "training" would be internal calibration processes rather than a distinct dataset.

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

• Not applicable. As a traditional physiological monitor, the concept of a "training set" and associated ground truth establishment for a machine learning model is not relevant to the information provided in this 510(k) summary.

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