(198 days)
The NPB3900 Series Patient Monitors are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure, (systolic, diastolic, and mean arterial pressure), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital areas and hospital type facilities and for patient transport in the hospital and in ambulances.
The NPB3900 Series Patient Monitors is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from four physiological measurements:
- Electrocardiogram (ECG). A three lead ECG is acquired and a . waveform can be displayed real-time on the LCD screen or permanently recorded on the optional strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
- Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated . from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses the same printed wiring board, including microprocessor and imbedded firmware that is used in the predicate device, the NPB-4000.
- The temperature is measured using thermistor probes and a . "predictive" algorithm to enable temperature measurements to be completed more quickly. The temperature subsystem uses technology licensed from the manufacturer of the Welch Allyn SureTemp® Portable Thermometer, which was cleared for marketing under premarket notification K943695 and K964643.
- Blood pressure is measured noninvasively (NIBP) by the oscillometric . method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
- An optional thermal printer records waveforms, digital vital signs, and . tabular trends on a 50-mm wide strip chart.
The NPB3900 series monitors are powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.
The provided text describes a 510(k) submission for the Analogic Corporation NPB3900 Series Patient Monitors. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information relevant to AI/algorithm performance, ground truth establishment for a training set, and expert qualifications/adjudication methods as typically found in studies for AI/ML-based devices.
The document outlines the device's features, intended use, and comparison to predicate devices, focusing on regulatory approval based on demonstrating substantial equivalence. The "clinical testing" section describes the types of studies performed but does not provide quantitative results or acceptance criteria in the format requested.
Therefore, many sections of your requested output cannot be filled from the provided text.
Here is an attempt to answer based on the available information, with many points marked as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
| Measurement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Not explicitly stated (likely defined by a standard, but not specified here) | "Accuracy of the SpO2 measurement was verified in a study on human volunteers." (No specific accuracy metric reported) |
| NIBP Accuracy | Not explicitly stated (likely according to ANSI/AAMI standard SP-10, but no specific threshold given) | "Clinical testing to validate the accuracy of the NIBP function was conducted according to the ANSI/AAMI standard SP-10." (No specific accuracy metric reported) |
| Overall Clinical Equivalence | Not explicitly stated (aimed at user perception of equivalence) | "A study was conducted to exercise all the device features in a typical clinical setting, to demonstrate that users perceive the NPB3900 as equivalent to other devices with the same intended use." (No specific metrics or thresholds reported) |
| Electromagnetic Emissions | EN 55011, Group 1, Class B limits | "All tests passed the stated criteria." |
| Electrostatic Discharge Susceptibility | IEC 801-2 | "All tests passed the stated criteria." |
| Radio Frequency Interference Susceptibility | IEC 801-3 | "All tests passed the stated criteria." |
| Electric Fast Transient Susceptibility | IEC 801-4 | "All tests passed the stated criteria." |
| Fast Surge Susceptibility | IEC 801-5 | "All tests passed the stated criteria." |
| Line Drop-Out and Variation Susceptibility | FDA Reviewer Guidance for Premarket Notification (Anesthesiology and Respiratory Devices Branch) | "All tests passed the stated criteria." |
| ECG Performance | ANSI/AAMI EC-13 | "All tests passed the stated criteria." |
| Battery Cycle Testing | Not explicitly stated | "All tests passed the stated criteria." |
| Operational Temperature Test | Not explicitly stated | "All tests passed the stated criteria." |
| Altitude Tests | Not explicitly stated | "All tests passed the stated criteria." |
| Alarm Volume Tests | Not explicitly stated | "All tests passed the stated criteria." |
| Cleanability Tests | Not explicitly stated | "All tests passed the stated criteria." |
| Mechanical Shock and Vibration Tests | Not explicitly stated | "All tests passed the stated criteria." |
| Shipping Container Transportation Test | Not explicitly stated | "All tests passed the stated criteria." |
| Measure of External Temperature Rise | Not explicitly stated | "All tests passed the stated criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for SpO2 study: "human volunteers" - specific number not provided.
- Sample Size for NIBP study: Not provided.
- Sample Size for Clinical Equivalence study: Not provided.
- Data Provenance: Not provided, but given the context of a US 510(k) submission, it's highly probable the studies were conducted in the US. The studies are described as "clinical testing," implying prospective data collection for the purpose of the submission.
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)
- Not applicable/Not provided. The studies described are for physiological measurement accuracy and user perception, not for diagnostic interpretation requiring expert ground truth in the way AI/ML devices often do. For SpO2 and NIBP, ground truth would typically come from reference devices or invasive measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. (See point 3).
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
- No. This is a patient monitor, not an AI/ML diagnostic imaging device that would typically involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The studies relate to the device's measurement accuracy (SpO2, NIBP) and overall clinical use. Performance would inherently be "standalone" in the sense that the device outputs measurements without human interpretation adjusting them in real-time. However, this is not an "algorithm only" study as understood in AI/ML contexts.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- SpO2: Likely comparisons against co-oximetry (gold standard for oxygen saturation) or a highly accurate reference pulse oximeter.
- NIBP: Likely comparisons against invasive arterial pressure measurements or a highly accurate reference oscillometric device, as per ANSI/AAMI standard SP-10.
- Temperature: Likely comparisons against a highly accurate reference thermometer, potentially invasive Core Body Temperature.
- ECG: Comparisons against standard ECG devices.
8. The sample size for the training set
- Not applicable/Not provided. The text describes a traditional medical device submitting for 510(k), not an AI/ML device relying on a distinct training set in the modern sense. The "design of the NPB3900 series" is described as being derived from the predicate NPB-4000, implying reuse of validated components and technology rather than training a novel algorithm on a specific dataset. The predictive temperature algorithm is "licensed from Welch Allyn," meaning its development and "training" would have occurred prior to this device's submission and were likely part of Welch Allyn's own validation for their thermometer.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
§ 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.