(30 days)
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
The 8100 / 8500 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8100 / 8500 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpO2, Temperature, Respiration, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8100 / 8500 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
The provided text is a 510(k) summary for the Criticare Systems, Inc. Model 8100/8500 Vital Signs Monitor. This document is a premarket notification for a medical device seeking clearance from the FDA, claiming substantial equivalence to previously cleared predicate devices. It describes the device's function, intended use, and its compliance with relevant standards. However, it does not contain the detailed study results, acceptance criteria, or specific performance metrics in the way that would typically be presented for a standalone AI/software-as-a-medical-device (SaMD) study.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that the device's performance for each monitoring modality "has been confirmed to be equivalent to the predicate devices" and that it "complies with applicable safety and performance standards." It lists numerous specific standards (e.g., EN 60601-2-30 NIBP Safety, AAMI SP-10 NIBP Performance, EN 865 Oximetry Performance).
- Reported Device Performance: The document generally states that the performance has been confirmed and complied with standards, but it does not provide numerical results or specific performance metrics against those standards. For example, it doesn't say "NIBP accuracy was within X mmHg, meeting the AAMI SP-10 requirement of Y mmHg."
| Parameter/Modality | Acceptance Criteria (Implicit) | Reported Device Performance (General) |
|---|---|---|
| ECG | Compliance with IEC 60601-2-27 and AAMI EC-13 | Confirmed equivalent to predicate, complies with standards. |
| NIBP | Compliance with EN 60601-2-30, EN1060-1, EN 1060-3, AAMI SP-10 (including EN 475 alarms) | Confirmed equivalent to predicate, complies with standards. |
| IBP | Compliance with EN 60601-2-34 | Confirmed equivalent to predicate, complies with standards. |
| SpO2 | Compliance with EN 865 (Equivalent to ASTM F 1415) | Confirmed equivalent to predicate, complies with standards. |
| Temperature | (Not explicitly listed, but implied under general physiological monitoring equivalence) | Confirmed equivalent to predicate, complies with standards. |
| Respiration | (Not explicitly listed, but implied under general physiological monitoring equivalence) | Confirmed equivalent to predicate, complies with standards. |
| CO2 | Compliance with EN 864 Capnometry Performance (Equivalent to ASTM F 1456) | Confirmed equivalent to predicate, complies with standards. |
| N2O | Compliance with EN ISO 11196 Anesthetic Gas Monitor Performance (Equivalent to ASTM F 1452) | Confirmed equivalent to predicate, complies with standards. |
| O2 | Compliance with EN 12598 Oxygen Analyzer Performance (Equivalent to ASTM F 1462) | Confirmed equivalent to predicate, complies with standards. |
| Halogenated Agents | Compliance with EN ISO 11196 Anesthetic Gas Monitor Performance (Equivalent to ASTM F 1452) | Confirmed equivalent to predicate, complies with standards. |
| Safety | Compliance with EN 60601-1, IEC 601-1-2, ISO 10993-5,10-11 | Complies with applicable safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "equivalence testing" and "field experience" but does not detail the methodology, sample sizes, or data provenance of any specific tests or studies.
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. This document describes a vital signs monitor, not a diagnostic AI device requiring expert ground truth for interpretation of images or complex data. The "ground truth" for vital signs monitoring typically comes from established reference methods (e.g., a known SpO2 calibration, a reference NIBP cuff, or an invasive arterial line for IBP comparison). The document mentions "CSI's field experience with these modalities in the predicate devices has been satisfactory," suggesting real-world data, but no specific expert panel for ground truth generation is indicated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as this is not a study involving expert interpretation of data.
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 is a vital signs monitor, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable in a different context. The device is a standalone monitoring system that measures physiological parameters. Its performance, in comparison to predicate devices and standards, would be considered its "standalone" performance for each parameter. However, the document doesn't detail the specifics of such testing beyond stating compliance. The "user... will be a professional health care provider," indicating that human interpretation is part of the overall clinical use, but the device itself performs the measurements independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied by standards. For vital signs monitors, ground truth typically involves reference devices or established physiological measurement techniques. For instance:
- NIBP: Likely compared against invasive arterial blood pressure measurements or a highly accurate reference NIBP device.
- SpO2: Likely compared against co-oximetry blood gas analysis or a reference oximeter in controlled desaturation studies.
- ECG: Compared against a reference ECG device/system that accurately captures cardiac electrical activity.
- Gas analysis (CO2, O2, N2O, Anesthetics): Likely compared against calibrated gas analyzers.
- The document implies that the ground truth for its "equivalence testing" and "compliance to standards" would have been established according to the methodologies prescribed by the relevant performance standards (e.g., AAMI SP-10 for NIBP, EN 865 for Oximetry).
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware-based vital signs monitor, not an AI/machine learning model that undergoes "training." Its performance is based on established physiological measurement principles embedded in its design.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no "training set" in the context of an AI/ML algorithm, this question is not relevant to the information provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).