(31 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended Use: For monitoring, recording, and alarming 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 SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor. These changes include two new models, enhancements and bug fixes. The new models include the VM3 Series Patient Monitor which is a subset of the predicate devices but does not perform NBP and the SureSigns VS3 Vital Signs monitor which is a subset of the predicate device and performs continuous SpO2 and intermittent measurements of SpO2, NBP, and pTemp. The enhancements include improvements in the areas of Patient Records, the Administering Patients, Networking, Data Export, improved board hardware, adding a SpO2 sensor and NBP cuffs.
The provided text is a 510(k) summary for the Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor. It describes the devices, their intended use, and substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a quantitative sense as typically expected for AI/CADe device submissions.
The document states:
- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate."
- "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 and test results showed substantial equivalence."
- "The results demonstrate that the Philips SureSigns VM Series Patient Monitors and SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."
This indicates that testing was performed and specific criteria were used, but the document does not provide the specific numerical acceptance criteria, reported device performance metrics against those criteria, or the methodology of the studies in detail (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).
Given the information provided, I cannot populate all the requested fields. Here's what I can extract and what is missing:
Acceptance Criteria and Study Details (Based on Provided Text)
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | Based on specifications cleared for the predicate device (K052707) | "Meet all reliability requirements and performance claims" and "showed substantial equivalence." |
| System Level | Based on specifications cleared for the predicate device (K052707) | "Showed substantial equivalence." |
| Performance | Based on specifications cleared for the predicate device (K052707) | "Showed substantial equivalence." |
| Safety | Based on specifications cleared for the predicate device (K052707) | "Showed substantial equivalence." |
Note: The document broadly mentions "specifications cleared for the predicate device" as the basis for acceptance criteria, but does not detail what those specific performance specifications were (e.g., accuracy for NBP, SpO2, ECG, etc.) or quantitative reported performance values.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "system level tests, performance tests, and safety testing," but not the nature of the data involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Ground truth establishment, if applicable to device performance testing, is not detailed. Given these are patient monitors for vital signs, the ground truth would likely be established by known physical standards, reference devices, or clinical measurements rather than expert consensus on images.
4. Adjudication method for the test set
- Not applicable as the text describes testing against specifications rather than expert adjudicated cases.
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 information is not provided and is highly unlikely to be relevant. The devices are patient monitors, not AI/CADe systems for interpreting complex medical images or data. The "enhancements" mentioned are clinical features, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The devices themselves are standalone in terms of their primary function (monitoring vital signs). The testing described would inherently be standalone performance against specified requirements. However, the exact performance metrics and results are not detailed.
7. The type of ground truth used
- Not explicitly stated, but for patient monitors, ground truth would typically come from:
- Reference standards/simulators: For electrical safety, accuracy of measurements (e.g., known pressure values for NBP, known SpO2 levels).
- Reference devices: Comparison against established, highly accurate medical devices.
- Clinical measurements: In some cases, direct physiological measurements.
8. The sample size for the training set
- Not applicable. These are traditional medical devices, not machine learning or AI algorithms requiring a "training set" in the conventional sense. The "enhancements" mentioned are likely software and hardware improvements, not model training.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
Summary:
The 510(k) summary provides a general overview of the devices and states that verification, validation, and testing were conducted. It confirms that the devices met "all reliability requirements and performance claims" and demonstrated "substantial equivalence" to a predicate device. However, it lacks the specific quantitative details regarding acceptance criteria, reported performance metrics, study methodologies (e.g., sample sizes, data provenance, ground truth details, expert involvement), or comparative effectiveness studies that would typically be found for AI-driven devices. This is consistent with a traditional medical device submission for vital signs monitors, which rely on meeting established performance standards rather than complex statistical validation studies against expert consensus for diagnostic accuracy.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.