(58 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:
NBP SpO2 Temperature
The SureSigns VSi Vital Signs monitor is for measurement 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. The VSi is different from the predicate device in that is has no physiological alarms, performs no continuous monitoring, has an internal power supply, and uses keys for navigation (no navigation wheel). The VSi stores less records than the predicate and does not have wireless communication.
The provided text is a 510(k) summary for the Philips SureSigns VSi Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device (SureSigns VS2) and does not detail specific acceptance criteria or a dedicated study report with performance metrics.
However, based on the information provided, we can infer some aspects and highlight what is not present:
Key Takeaways from the document:
- Device Type: Multi-parameter patient monitor for Non-Invasive Blood Pressure (NBP), SpO2 (Oximeter), and Temperature.
- Purpose of Submission: To demonstrate substantial equivalence to the SureSigns VS2.
- Testing Philosophy: "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. The results demonstrate that the Philips SureSigns VSi Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence."
Given the above, I cannot provide a table of acceptance criteria and reported device performance with specific numerical values because this document does not contain them. This 510(k) summary asserts that internal tests were conducted against pre-defined specifications to demonstrate substantial equivalence, but it does not provide the details of those specifications or the quantitative results. This is common for 510(k) summaries, which are often high-level overviews.
Therefore, the following answers will reflect the information available and absent in the provided text.
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Implicit/General) | Reported Device Performance (Implicit/General) |
|---|---|---|
| NBP | To meet specifications aligned with the predicate device (SureSigns VS2). | Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device. |
| SpO2 | To meet specifications aligned with the predicate device (SureSigns VS2). | Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device. |
| Temperature | To meet specifications aligned with the predicate device (SureSigns VS2). | Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device. |
| Overall | Meet all reliability requirements and performance claims for substantial equivalence. | Device meets all reliability requirements and performance claims, supporting a determination of substantial equivalence. |
Explanation: The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence." However, the specific numerical acceptance criteria (e.g., NBP accuracy ranges, SpO2 error margins, temperature precision) or detailed performance metrics from these tests are not provided in this 510(k) summary. It only broadly states that the device "meets all reliability requirements and performance claims."
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 document. The general statement "Verification, validation, and testing activities" does not specify the sample sizes for any of the tests conducted, nor does it indicate the provenance of any data (e.g., patient data for performance evaluation).
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 document. For a vital signs monitor, "ground truth" might refer to reference measurements from highly accurate, calibrated instruments or clinical gold standards. The document does not describe the methodologies for establishing ground truth during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for subjective assessments or when multiple experts are involved in interpreting results. For a vital signs monitor, testing would likely involve comparing device readings against reference standards, which wouldn't typically involve an adjudication process described in this manner.
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 is not applicable and not provided in the document. An MRMC study is relevant for diagnostic imaging devices where human readers (e.g., radiologists) interpret images, often with or without AI assistance. The Philips SureSigns VSi Vital Signs Monitor is a device that directly measures physiological parameters and does not involve "human readers" in the context of interpreting complex medical images. It's a direct measurement device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the context of "algorithm only performance." The document states, "The subject devices use the same algorithms for the measurements as the predicate device." It also mentions "system level tests, performance tests, and safety testing." While these tests would inherently evaluate the algorithms, the document doesn't isolate and report on "algorithm-only" performance metrics distinct from the integrated device performance. The device itself is designed for direct measurement, so its "standalone" performance is its operational performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the document. For a vital signs monitor, ground truth would typically be established by highly accurate, often invasive or laboratory-grade, reference measurement devices for NBP, SpO2, and temperature against which the SureSigns VSi's readings are compared. The document does not specify these reference methods.
8. The sample size for the training set
This information is not provided in the document. The document mentions that the device uses "the same algorithms for the measurements as the predicate device." This suggests that the algorithms were developed and potentially "trained" (if they involve machine learning, which is not indicated for these standard vital signs algorithms) prior to this specific device's development, likely for the predicate VS2 monitor. Details about the training set for those algorithms are not part of this 510(k) submission.
9. How the ground truth for the training set was established
This information is not provided in the document. Given that the algorithms are shared with the predicate device, the ground truth for their original development would have been established during the development of the predicate. This document does not detail those historical development practices.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).