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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.

The Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors are multi-parameter patient monitors. The modifications include a new OEM CO2 module, addition of an apnea alarm, a new main board, modified front end board, alternate internal component speaker, optional bar code reader, optional RS232 serial port adaptor, several new accessories, and software enhancements. Impedance respiration is added to SureSigns VM4.

1. Acceptance Criteria and Reported Device Performance

The provided text only 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." It does not explicitly list specific acceptance criteria or quantitative performance metrics. It generally asserts that the device "meet all reliability requirements and performance claims."

2. Sample Size and Data Provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "system level tests, performance tests, and safety testing from hazard analysis."

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The type of device (patient monitor) and the nature of modifications (hardware and software enhancements to existing parameters, addition of alarms) suggest that "ground truth" might be established through comparisons with reference measurement devices or established clinical standards, rather than expert consensus on image interpretation, for example.

4. Adjudication Method

The document does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The evaluation focuses on technical performance and equivalence to a predicate device.

6. Standalone Performance (Algorithm Only)

The device itself is a standalone patient monitor, and its performance was evaluated. However, the term "standalone" in the context of AI often implies an algorithm's performance without any human-in-the-loop. In this case, the device monitors physiological parameters and provides alarms directly, so its performance is inherently standalone in generating these outputs. The text indicates that "testing activities establish the performance, functionality, and reliability characteristics of the subject devices."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, the ground truth would typically be established by:

• Reference standard devices: Comparing the device's readings against highly accurate and calibrated reference instruments for each physiological parameter (e.g., a clinical-grade blood pressure cuff for NBP, a calibrated pulse oximeter for SpO2, a gas analyzer for CO2).
• Physical simulators: For certain parameters, using simulators that can generate precise physiological waveforms or values.
• Clinical standards/established norms: Ensuring basic functionality and alarm thresholds align with recognized clinical practices.

8. Sample Size for the Training Set

The document does not specify any training set sample size. This type of device (patient monitor with hardware and software modifications to existing parameters) is unlikely to have a "training set" in the sense of machine learning models requiring large datasets for training. Its development would involve engineering design, component testing, and system-level validation against specifications, not typically a data-driven training process in the modern AI sense.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

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