Search Results

The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment 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), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
• The arrhythmia detection and PAWP monitoring is intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.

The subject ePM Series Patient Monitors includes six monitors:
• ePM 10 Patient Monitor
• ePM 12 Patient Monitor
• ePM 15 Patient Monitor
• ePM 10M Patient Monitor
• ePM 12M Patient Monitor
• ePM 15M Patient Monitor
The ePM 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 text describes a 510(k) premarket notification for the ePM Series Patient Monitors, arguing their substantial equivalence to a predicate device (BeneVision N Series Patient Monitors). The document outlines various performance characteristics and how they compare to the predicate, along with general statements about testing performed.

There is no specific study detailed that "proves the device meets the acceptance criteria" in terms of clinical performance or a comparative effectiveness study with human readers. The document primarily focuses on demonstrating that the new device's technological characteristics and performance specifications are equivalent to the predicate device. The information details bench testing and compliance with consensus standards to show that the device meets its accuracy specifications and does not raise new questions of safety and effectiveness.

Therefore, the requested information elements related to a specific study, such as sample size, expert adjudication, MRMC studies, or standalone algorithm performance, cannot be extracted from this document as such a study is not described. The document discusses performance specifications and claims that bench testing validates these specifications and shows substantial equivalence.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant standards. The reported device performance is presented as being "the same" or having "minor circuit board layout differences" but maintaining the same specifications as the predicate. The document doesn't provide a direct table of acceptance criteria with reported performance, but rather a comparison table of features and specifications between the subject device and the predicate.

Below is a summary derived from the "Technological Comparison" table (Table 2) and subsequent explanatory text, focusing on the measurement parameters where performance specifications are explicitly mentioned or affirmed as "same":

2. Sample size used for the test set and the data provenance:

• Not specified. The document mentions "functional and system level testing" and "bench testing" to validate performance and show compliance with specifications and standards but does not provide details on the sample sizes of any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data used in these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. No mention of experts establishing ground truth for any test sets. The testing referenced is primarily device-centric (bench testing, software verification).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified. No information about adjudication methods.

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 MRMC study was done or reported. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The performance described relates to the device's ability to measure physiological parameters in a standalone capacity. The "reported device performance" entries in the table indicate that the device met the measurement specifications (accuracy, range) without human interpretation in the loop. The document states a "standalone" performance was done in the sense that the device's own measurements were tested against its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the performance testing, the ground truth is implied to be reference measurements from known standards and calibrated equipment during "bench testing" against accuracy specifications and consensus standards (e.g., IEC standards for ECG, NIBP, SpO2). There is no mention of clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable / not specified. The document describes a patient monitor that directly measures physiological parameters. It does not refer to machine learning models that require training sets.

9. How the ground truth for the training set was established:

• Not applicable. As no training set is discussed, there is no information on how its ground truth was established.

Ask a specific question about this device