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510(k) Data Aggregation
(142 days)
The uMEC Series Patient Monitor family consists of the uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below.
The uMEC series patient monitors are intended for monitoring, displaying, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), carbon dioxide (CO2).
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection and SpO2 are intended for adult and pediatric patients only; ST Segment analysis is intended for adult patients only; and C.O. monitoring is restricted to adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.
The subject uMEC Series Patient Monitors include six monitors:
- uMEC6 Patient Monitor
- uMEC7 Patient Monitor
- uMEC10 Patient Monitor
- uMEC12 Patient Monitor
- uMEC15 Patient Monitor
- uMEC15S Patient Monitor
The uMEC Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.
The provided document is a 510(k) Summary for patient monitors, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria for AI algorithms.
Therefore, many of the requested elements for describing the acceptance criteria and the study proving the device meets them (especially those related to AI and human-in-the-loop performance) cannot be directly extracted from this document. The document outlines performance data related to the functional and system-level performance of the patient monitors (such as ECG accuracy, NIBP accuracy, etc.) by conforming to established consensus standards and conducting internal testing, but it does not describe a clinical study of an AI-based algorithm.
However, I can extract information regarding the performance specifications for various physiological parameters as presented in the "Comparison of Technological Characteristics" section, which can be interpreted as the device's inherent acceptance criteria for these parameters.
Let's break down what can be extracted and what cannot:
Information that can be extracted or inferred:
- Acceptance Criteria (as performance specifications): The comparison table details measurement ranges and accuracies for various physiological parameters (ECG, Respiration, Temp, SpO2, PR, NIBP, IBP, C.O., CO2). These are effectively the performance claims the device must meet.
- Study Proving Acceptance Criteria: The document states that "Mindray conducted functional and system level testing on the subject device" and "Mindray has conducted testing to ensure the subject device meets relevant consensus standards." This indicates the type of study/testing performed, which is primarily non-clinical, bench testing, and verification against standards.
Information that CANNOT be extracted from this document:
- AI-specific Acceptance Criteria/Performance: The document does not describe AI components or their performance.
- Sample size for test set (clinical): The document refers to "functional and system level testing" and conformity to standards, not a specific clinical test set with a patient sample size.
- Data provenance for test set: Not available as it's not a clinical study on a data set.
- Number/qualifications of experts for ground truth: Not applicable for non-clinical, functional testing.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned, as it's not an AI device.
- Standalone (algorithm-only) performance: Not mentioned.
- Type of ground truth used (clinical): Not specified beyond "relevant consensus standards" for verification.
- Sample size for training set (AI): Not applicable.
- How ground truth for training set was established (AI): Not applicable.
Given these limitations, here is the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a patient monitor, "acceptance criteria" are typically defined by the accuracy and measurement ranges across various physiological parameters. The document compares the subject device's performance claims against those of the predicate device.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (uMEC Series) |
|---|---|---|
| ECG Heart Rate (HR) | Measurement Range: | |
| Neonate: 15 to 350 bpm; | ||
| Pediatric: 15 to 350 bpm; | ||
| Adult: 15 to 300 bpm; | ||
| Accuracy: ±1 bpm or ±1%, whichever is greater. | Same as predicate device. | |
| ECG ST Segment | Measurement Range: -2.0 to 2.0 mV RTI; | |
| Accuracy: | ||
| -0.8 to 0.8 mV: ±0.02 mV or ±10%, whichever is greater. | ||
| Beyond this range: Not specified. | Same as predicate device. | |
| ECG QT | Measurement Range: [200, 800]ms; | |
| Accuracy: ±30ms | Same as predicate device. | |
| Arrhythmia Analysis | Asystole, VFib/VTac, Vtac, Vent. Brady, ExtremeTechy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, RunPVCs,PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, Afib. | Same as predicate device. |
| Respiration Rate (Resp) | Measurement Range: | |
| Adult: 0 to 120 rpm; | ||
| Pediatric, neonate: 0 to 150 rpm. | ||
| Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater; | ||
| 0 to 6 rpm: Not specified. | Same as predicate device. | |
| Temperature (Temp) | Measurement Range: 0 to 50 °C (32 to 122 F) | |
| Accuracy: ±0.1 °C or ±0.2 F (without probe) | Same as predicate device. | |
| Pulse Oxygen Saturation (SpO2) | MindraySpO2 Module: | |
| Measurement Range: 0 to 100% | ||
| Accuracy: 70 to 100%: ±2% (adult/pediatric mode) | ||
| 70 to 100%: ±3% (neonate mode) | ||
| 0% to 69%: Not specified. | ||
| (Note: Masimo & Nellcor SpO2 Modules also listed for predicate) | MindraySpO2 Module: | |
| Measurement Range: 0 to 100% | ||
| Accuracy: 70 to 100%: ±2% (adult/pediatric mode) | ||
| 0% to 69%: Not specified. | ||
| MindraySpO2 Module do not support neonate mode and the specifications for Adult/pediatric are same. | ||
| Not Support Masimo and NellcorSpO2 Module. (This is a difference, not an identical acceptance criterion, and indicates a narrower scope for the uMEC). | ||
| Pulse Rate (PR) | From MindraySpO2 Module: | |
| Measurement Range: 20 to 254 bpm | ||
| Accuracy: ±3 bpm | ||
| (Other module PR also listed) | From MindraySpO2 Module: | |
| Measurement Range: 20 to 254 bpm | ||
| Accuracy: ±3 bpm | ||
| Not Support Masimo and NellcorSpO2 Module. | ||
| From IBP Module: | ||
| Measurement Range: 25 to 350 bpm | ||
| Accuracy: ±1 bpm or ±1%, whichever is greater. | ||
| Non-Invasive Blood Pressure (NIBP) | Measurement Ranges (Systolic/Diastolic/Mean): | |
| Adult: 40-270 / 10-210 / 20-230 mmHg | ||
| Pediatric: 40-200 / 10-150 / 20-165 mmHg | ||
| Neonate: 40-135 / 10-100 / 20-110 mmHg | ||
| Accuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Measurement Ranges (Systolic/Diastolic/Mean): | |
| Adult: 25-290 / 10-250 / 15-260 mmHg | ||
| Pediatric: 25-240 / 10-200 / 15-215 mmHg | ||
| Neonate: 25-140 / 10-115 / 15-125 mmHg | ||
| Accuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | ||
| The measurement range of subject devices is wider than the predicate device. | ||
| Invasive Blood Pressure (IBP) | Measurement Range: -50 to 300 mmHg | |
| Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor) | Same as predicate device (where supported). uMEC6 does not support IBP. | |
| Cardiac Output (C.O.) | Measurement Range: C.O: 0.1 to 20 L/min; TB: 23 to 43 °C; TI: 0 to 27 °C | |
| Accuracy: C.O: ±5% or ±0.1 L /min, whichever is greater; TB, TI: ±0.1 °C (without sensor) | Same as predicate device (where supported). Not supported by uMEC6, uMEC10, uMEC7. | |
| Carbon Dioxide (CO2) | Sidestream CO2 Module: | |
| Measurement Range: 0 - 13% | ||
| Accuracy: 0-5%: ±0.26% abs; 5-10%: ±5% of the reading; 10-13%: ±10% of the reading; ±0.3% ABS increase in error for ISO accuracy mode. | ||
| awRR Range: 0 to 120rpm | ||
| awRR Accuracy: ±2rpm | Sidestream CO2 Module: | |
| Measurement Range: 0 to 20% | ||
| Accuracy: CO2 concentration |
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