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The ePM 10/ePM 12/ePM 15/ePM 10M/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 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 document is a 510(k) Summary for the ePM Series Patient Monitors (K200015) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. This document describes the device, its intended use, and the data presented to the FDA to demonstrate substantial equivalence to predicate devices.

While the document details various performance specifications and mentions "functional and system level testing," and "bench testing," it does not provide explicit acceptance criteria in a table format, nor does it present detailed study results proving the device meets specific criteria for the entire suite of monitored parameters. It primarily focuses on demonstrating that the subject device's technological characteristics and performance are substantially equivalent to previously cleared predicate devices and meet relevant consensus standards.

However, based on the provided text, I can extract and infer information about performance and testing related to the ECG and Arrhythmia detection features, which are directly relevant to the regulation number 21 CFR 870.1025.

Here's an attempt to answer your questions based on the available information, with specific limitations noted where details are not provided:

Acceptance Criteria and Study Details for ePM Series Patient Monitors (K200015)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as a separate, quantified target for each parameter, but rather lists "accuracy" or "measurement range" as performance specifications. The "reported device performance" is essentially implied to be within these stated specifications as a result of the conducted testing.

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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":

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