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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes (e.g., number of patients, number of ECG recordings) for any of the performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). It refers to "functional and system level testing" and "bench testing."

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)

The document does not mention the use of experts to establish ground truth for any test set. The testing described appears to be technical validation against device specifications and consensus standards, not clinical evaluation against expert interpretations. For cardiac rhythm and ST-segment algorithms, ground truth (reference data) might come from adjudicated annotated databases, but this is not detailed in the summary.

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

The document does not describe any adjudication method. This is consistent with the lack of mention of expert ground truth establishment.

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 comparative effectiveness study is mentioned in the document. This submission is for a patient monitor, which provides measurements and alarms, 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 entire device, including its measurement algorithms for ECG, arrhythmia detection, ST-segment analysis, SpO2, NIBP, etc., operates in a "standalone" mode in terms of generating these measurements and alarms. The document states that "software verification and validation testing was conducted" and "bench testing" was performed to ensure the device meets its accuracy specifications and relevant consensus standards. This implies algorithm-only performance assessment against known inputs or reference standards rather than a human-in-the-loop study.

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

The document primarily states that the device's performance was validated against its internal specifications and relevant consensus standards (e.g., IEC 60601-2-27, AAMI / ANSI EC57). For these types of medical devices (patient monitors), ground truth for performance characteristics like accuracy and detection capability often comes from:

• Physiological simulators: Generating known, controlled signals for parameters like ECG arrhythmias, SpO2, NIBP.
• Standardized databases: For ECG analysis, widely accepted databases of annotated ECG waveforms (e.g., MIT-BIH Arrhythmia Database) are often used to test algorithm performance against "expert consensus" annotations within those databases.
• Reference measurement equipment: Calibrated instruments used to establish the true value of a physiological parameter during bench testing.

The document does not explicitly state which specific type of ground truth was used beyond referring to "bench testing" and "consensus standards."

8. The sample size for the training set

The document discusses "software verification and validation testing" and "bench testing" but does not mention a "training set". This implies that the device's algorithms were developed and validated internally against specifications and standards, rather than explicitly being derived from a separate "training set" as might be seen for machine learning or AI models with a distinct learning phase. If machine learning was used, details about its training would be expected.

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

Since no "training set" is described, the method for establishing its ground truth is also not provided.

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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":

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.

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