(92 days)
The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
| Patient Types | |||
|---|---|---|---|
| Parameter | Adult | Pediatric | Neonatal |
| NBP | √ | √ | √ |
| SpO2 | √ | √ | √ |
| Temperature | √ | √ | √ |
The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
| Patient Types | |||
|---|---|---|---|
| Parameter | Adult | Pediatric | Neonatal |
| NBP | √ | √ | √ |
| SpO2 | √ | √ | √ |
| Temperature | √ | √ | √ |
| CO2 | √ | √ | √ |
| RRa | √ | √ | |
| SpHb | √ | √ |
The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.
This document describes the Philips SureSigns VS3 and VS4 Vital Signs Monitors, which are multi-parameter patient monitors. The submission is a 510(k) premarket notification for modifications to previously cleared devices.
Here's an analysis of the acceptance criteria and study information provided, focusing on what can be extracted from the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "Pass/Fail criteria were based on the specifications cleared for the subject device." However, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy ranges for NBP, SpO2, Temperature, CO2). Instead, it confirms that the device reportedly meets these implicit criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Reliability Requirements | Test results demonstrate that the Philips SureSigns VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all safety and reliability requirements. |
| Performance Claims (based on cleared specifications) | Test results demonstrate that the Philips SureSigns VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all performance claims. The added Temporal Temperature measurement to VS3 will have the same specification with that from the predicate VS4. |
| Functionality | Verification, validation, and testing activities establish the functionality characteristics of the subject device. |
| IEC 62304: 2006 compliance (for software) | The modified software for VS3 and VS4 (version A.06) complies with IEC 62304: 2006 - Medical Device Software life-cycle processes. |
| ISO 80601-2-56: 2009 + CORR. 2 (2007) compliance (for temperature) | Both VS3 and VS4 (for Temporal Temperature measurement) comply with ISO 80601-2-56: 2009 + CORR. 2 (2007). Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. |
| Substantial Equivalence | Test results showed substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by Philips Medical Systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is verification, validation, and performance testing, which typically involves comparing device outputs to a known reference standard (e.g., calibration equipment, established measurement methods) rather than human expert-established ground truth in a clinical scenario.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device (monitoring physiological parameters), "adjudication" in the sense of resolving discrepancies between human experts for a diagnostic task is unlikely to be relevant here. The testing would involve comparing device readings against a gold standard or reference measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The SureSigns VS3 and VS4 are vital signs monitors, not diagnostic imaging devices designed for human interpretation of complex data patterns in the same way. The modifications focus on software connectivity, a new temperature measurement accessory, and feature enhancements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes "system level tests, performance tests, and safety testing from hazard analysis." This strongly implies that standalone performance testing was done for the device's functions (e.g., accuracy of NBP, SpO2, Temperature measurements). The software verification and validation, along with compliance to specific standards for temperature measurement, suggest testing of the algorithms and hardware in a standalone capacity against reference standards. However, "standalone" in the context of an AI algorithm is typically for diagnostic or predictive AI, which this device, in its described modifications, does not appear to be. It's a measurement device.
7. The Type of Ground Truth Used
The ground truth used for these types of physiological parameter monitors would typically involve:
- Reference standard instruments: Highly accurate and calibrated devices used to establish the true value of parameters like NBP, SpO2, and Temperature.
- Known physical inputs: For example, precise temperature probes, blood pressure simulators, or SpO2 simulators with defined oxygen saturation levels.
- Compliance with industry standards: The mention of ISO 80601-2-56 for temperature indicates that the ground truth for temperature measurement accuracy would be established by following the specific protocols and reference measurements outlined in that standard.
The document does not explicitly state "expert consensus" or "pathology" as ground truth, which are more relevant for diagnostic AI applications.
8. The Sample Size for the Training Set
The document does not describe any "training set." This is because the device, based on the provided information, is a vital signs monitor and not an AI/ML-based diagnostic or predictive system that requires a training set for model development. The focus is on measurement accuracy and software functionality.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, this information is not applicable/provided.
§ 870.1100 Blood pressure alarm.
(a)
Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.(b)
Classification. Class II (performance standards).