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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
• SpOz .
• Temperature

Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor. Common usual name for both the VS3 and the VS4 are multi-parameter patient monitor.

This Philips 510(k) summary does not contain the detailed acceptance criteria or a comprehensive study report with specific performance metrics as requested. The available information primarily focuses on establishing substantial equivalence to a predicate device, rather than providing robust statistical evidence of performance against defined acceptance criteria.

However, based on the provided text, here’s an attempt to extract and infer the closest available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document states, "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

This indicates that some acceptance criteria existed, based on the cleared specifications of the predicate device (SureSigns VS3, K082280 and K090483). However, the specific numerical or qualitative acceptance criteria (e.g., accuracy ranges for NBP, SpO2, Temperature) are not detailed in this summary. The reported performance is a general statement of compliance, without specific metrics.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given text. There are no details regarding the number of test subjects, the type of data (e.g., country of origin, retrospective/prospective), or the specific test protocols followed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. The testing appears to be device-centric (system level, performance, safety) rather than relying on expert consensus for clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used when expert consensus is required for ground truth, which isn't described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text. The document focuses on the device's technical performance and safety, not on human reader improvement with or without AI assistance. This device is a vital signs monitor, which typically provides direct measurements rather than interpreting complex medical images or data that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described appears to be a standalone performance evaluation of the device. The text mentions "system level tests, performance tests, and safety testing from hazard analysis," which are typically conducted to assess the device's internal algorithms and hardware functionality independently. The statement "The subject devices use the same algorithms for the measurements as the predicate devices" further supports that the algorithms themselves were evaluated for performance.

7. The Type of Ground Truth Used

The type of "ground truth" implicitly used for this device would be calibrated reference standards and established physiological measurement techniques. For vital signs monitors, this typically involves:

• For NBP: Comparison against invasive arterial blood pressure measurements or highly accurate non-invasive methods in a controlled setting.
• For SpO2: Comparison against co-oximetry readings of arterial blood samples.
• For Temperature: Comparison against highly accurate reference thermometers.

The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device," which implies these specifications included accuracy ranges against such reference standards. However, the specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document indicates that the devices use "the same algorithms for the measurements as the predicate devices," suggesting that any algorithm training would have occurred during the development of the predicate device, or that the algorithms are based on established physiological principles rather than machine learning requiring a training set in the contemporary sense.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the given text, and the concept of a "training set" in a machine learning context is not directly applicable given the device type and the description provided. If algorithms were "trained" in a broader sense (e.g., fine-tuning parameters), their "ground truth" would likely have been established through controlled studies using calibrated reference measurements, similar to the ground truth for validation, but this is speculative given the lack of detail.

Summary of Limitations in the Provided Text:

The provided 510(k) summary is very high-level and lacks the specific details required to fully address your questions. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with explicit acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies. For these details, one would typically need to refer to the full testing documentation submitted to the FDA, which is not included in this summary.

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