Search Results

The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, Pediatric); ST segment Analysis (Adult);

Contraindications: Not for transport outside the healthcare facility

The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.

This document describes the regulatory submission for the Philips Efficia CM10, CM12, CM100, CM120, and CM150 patient monitors, which are physiological vital signs monitors. The submission includes information about the device's intended use, parameters measured, and a comparison to predicate devices. The listed parameters, which include ECG, Respiration, NBP, SpO2, Temperature, IBP, Cardiac Output, Arrhythmia Analysis, and ST-Segment monitoring, also specify the patient types (adult, pediatric, neonatal) for which each parameter is indicated.

1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices." and that the devices "use the same algorithms and have the similar performance to their predicates." Specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) are not explicitly provided in the provided text, nor are specific numerical results for the device performance against such criteria. The submission relies on the assertion that the device's performance is at least equivalent to the predicate devices.

2. Sample size used for the test set and data provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for performance studies. It generally refers to "performance data" and a "device history file" without specific details.

3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided in the document.

4. Adjudication method for the test set
This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the document states that the ECG, NBP, invasive blood pressure, arrhythmia, and ST-segment analysis algorithms are Philips proprietary or derived from established Philips algorithms, and other parameters use algorithms from other manufacturers (e.g., Masimo, Respironics), it does not explicitly detail a standalone performance study. The statement "Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices" implies some form of performance evaluation, but the methodology and whether it was standalone are not described.

7. The type of ground truth used
The type of ground truth used for performance evaluation is not specified in the provided text. It can be inferred that, for physiological parameters like ECG, NBP, SpO2, etc., ground truth would typically come from reference devices, established clinical methods, or expert interpretation of physiological waveforms.

8. The sample size for the training set
This information is not provided in the document. The algorithms are either Philips proprietary and "well established" or from other manufacturers and "unchanged," suggesting they were developed and trained prior to this specific submission, but details about the training set size are absent.

9. How the ground truth for the training set was established
This information is not provided in the document. As with the test set, the establishment of ground truth for training would likely involve reference devices, clinical standards, or expert review of physiological data, but no specifics are given.

Ask a specific question about this device