(380 days)
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The VS Newborn Heart Rate Monitor is a non-invasive device intended to continuously monitor heart rate (HR) in neonates immediately after delivery and in newborn intensive care units (NICU). The VS Newborn Heart Rate Monitor measures HR using reflectance photoplethysmography (PPG). The sensor is integrated into a single-use soft cap placed on the head of the newborn such that the sensor contacts the forehead of the newborn. The PPG signal and HR are displayed on the monitor. The VS Newborn Heart Rate Monitor is designed for use in hospitals.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Preamble: The provided document is an FDA 510(k) clearance summary for the VS Newborn Heart Rate Monitor. It describes the device, its intended use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, pass/fail format like a typical study protocol would. Instead, it describes clinical endpoints used to demonstrate reliability, accuracy, and safety. The performance is then reported in relation to these endpoints and compared to established standards of care or predicate devices.
| Acceptance Criteria (Implied/Stated Endpoints) | Reported Device Performance |
|---|---|
| Reliability and Accuracy (Primary Endpoint): Demonstrated through Bland-Altman limits of agreement. | "The subject device was found to... be as reliable and accurate as the devices it was compared to." (Specific Bland-Altman limits of agreement or other quantitative accuracy metrics are not provided in this summary document.) |
| Safety (Secondary Endpoints): | |
| - Thermal properties comparison to standard of care. | "The subject device was found to maintain temperature as well as the standard of care..." |
| - Absence of skin damage/irritation due to the device. | "...there were no signs of skin irritation..." |
| - Absence of other unanticipated adverse events attributed to the device. | "...or adverse events therefore demonstrating that the VS Newborn Heart Rate Monitor is safe." |
| Acquisition Time (Secondary Endpoint): | No specific performance metric or comparison for acquisition time is provided in this summary, other than it being an endpoint. |
| User Feedback (Secondary Endpoint): | "to obtain feedback about the subject device from mothers and healthcare professionals." (No specific summary of feedback is provided in this document.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: In total, 74 newborns, 13 mothers, and 40 healthcare professionals participated in the study. While not explicitly stated as "test set," this represents the participants in the clinical validation study.
- Data Provenance: The clinical testing was conducted at the Nottingham University Hospitals NHS Trust, in Nottingham, England. The study appears to be prospective, as it involved actively collecting data from newborns, mothers, and healthcare professionals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. It implies that the ground truth for heart rate measurements was established by comparison devices that are considered standards of care.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth appears to be derived directly from concurrently measured physiological data from established monitoring devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a monitor measuring physiological parameters, not an AI diagnostic imaging tool that human readers would interact with. The comparison was device-to-device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance assessment was conducted. The primary endpoint focused on the reliability and accuracy of the device's heart rate measurements (algorithm's output) compared to the measurements from the comparison devices (ECG electrodes and pulse oximetry sensors). There is no mention of human intervention or interpretation being part of the primary measurement process for the VS Newborn Heart Rate Monitor's output itself; it measures and displays HR continuously.
7. Type of Ground Truth Used
The ground truth for heart rate measurements was established using concurrent measurements from established medical devices considered the standard of care:
- ECG electrodes (K024264)
- LNCS pulse oximetry sensors (K110723)
- These devices were connected to a CARESCAPE Monitor B450 (K132533), and all data, including from the subject device, was recorded synchronously to a laptop computer.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" or its size. This suggests the primary clinical testing was for validation of the device, rather than training a machine learning model from scratch with a separate training cohort. While there might have been internal development data (a "training set"), it's not discussed in this FDA summary.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned in the summary, there is no information provided on how its ground truth would have been established. It's plausible that any internal algorithm development or training would have used similar methods of comparison to established physiological monitoring, but this remains speculative based on the provided text.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).