(45 days)
The purpose and function of the C3 patient monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.
The C3 Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five 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 optical 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 a similar printed wiring board, software and firmware that is used in the predicate device, the NPB-4000.
- The temperature is measured using thermistor probes for continuous temperature measurements.
- Blood pressure is measured non-invasively (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.
- End-tidal CO2. This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system.
- An optional thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart.
The C3 monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.
Here's an analysis of the provided text regarding the Analogic C3 Patient Monitor, focusing on acceptance criteria and supporting studies:
Assessment of the Provided Information:
The provided document (K030931) is a 510(k) summary for a patient monitor. It primarily discusses the device description, intended use, comparison to a predicate device, and non-clinical tests conducted for substantial equivalence. It is important to note that this document is a 510(k) summary for a patient monitor, not a device related to AI/ML or image analysis. As such, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, ground truth for training set) are not applicable to this type of device and submission.
The "acceptance criteria" discussed are largely related to compliance with recognized standards for medical electrical equipment and functional performance of physiological measurements, rather than diagnostic accuracy or AI model performance. The "study" refers to the non-clinical testing performed to demonstrate that the device meets these standards and functions as intended.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Safety | IEC 60601-1 | All tests passed the stated criteria. |
| Electromagnetic Compatibility | EN 55011, Group 1, Class B emissions limits | All tests passed the stated criteria. |
| IEC 60601-1-2 | All tests passed the stated criteria. | |
| Power/Line Stability | FDA Reviewer Guidance for PreMarket Notification Submissions, November 1993 (Anesthesiology and Respiratory Devices Branch) for Line Dropout and Variation Susceptibility | All tests passed the stated criteria. |
| Battery Performance | Battery Cycle Testing | All tests passed the stated criteria. |
| Environmental Performance | Operational Temperature Test | All tests passed the stated criteria. |
| Altitude Tests | All tests passed the stated criteria. | |
| Physical/Mechanical | Alarm Volume Tests | All tests passed the stated criteria. |
| Cleanability Tests | All tests passed the stated criteria. | |
| Mechanical Shock and Vibration Tests | All tests passed the stated criteria. | |
| Shipping Container Transportation Test | All tests passed the stated criteria. | |
| Measure of External Temperature Rise | All tests passed the stated criteria. | |
| ECG Performance | AAMI/ANSI EC-13 | All tests passed the stated criteria. |
| EtCO2 Performance | EN 864/1996 | All tests passed the stated criteria. |
| SpO2 Performance | EN865, Pulse Oximeters Particular requirements: 1997 | All tests passed the stated criteria. |
| NIBP Performance | AAMI/ANSI SP10, Electronic or Automated Sphygmomanometers, 2nd Ed.: 1992 | 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):
- Not Applicable. This document describes non-clinical engineering and functional testing of a patient monitor, not a study involving patient data or a "test set" in the context of AI/ML or diagnostic performance evaluation. The tests are performed on the device itself under controlled conditions.
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. As above, there is no "test set" requiring expert ground truth in the diagnostic sense for this type of device submission. The "ground truth" for these tests are the established parameters and performance limits defined by the referenced industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is necessary or mentioned, as the evaluation involves meeting predefined engineering and performance standards, not resolving disagreements in diagnostic interpretations.
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:
- Not Applicable. This device is a patient monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study testing human reader improvement with AI assistance was performed or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device measures and displays physiological parameters. It does not employ an "algorithm" in the sense of an AI model that performs a diagnostic task independently. Its performance is inherent in its hardware and embedded firmware/software, which are tested for functional accuracy against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the non-clinical tests performed is the specified performance criteria and limits defined within the referenced consensus standards (e.g., IEC 60601-1, AAMI/ANSI EC-13, EN865). For example, if a standard specifies a blood pressure accuracy of +/- 5 mmHg, then a measurement within that range is considered "ground truth" for compliance.
8. The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.