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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI.

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
• Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
• Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
• Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable to the predicate device.

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

• Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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)

• Not applicable/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

• Not applicable/Not provided. As no performance study with a test set requiring adjudication is described.

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

• Not applicable/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

• Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

• Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

• Not applicable/Not provided. As there is no mention of a training set.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.

The Monitor B40 is not intended for use during MRI.

The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network.

The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2.1 still is a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2 (K130584) and now includes supporting for an additional optional extension module Airway Gas Option (N-CAiO), and few software improvements by adding alarm breakthrough, extending the upper limit of ECG PVC (Premature Ventricular Contraction) alarm and providing four waveform scale options for Masimo SpO2 and Nellcor SpO2. Same as the predicate Monitor B40V2 (K130584), the proposed Monitor B40V2.1 continues interfacing with following optional extension modules: E-MiniC module (K052582), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and E-Entropy module (K061907). The compatibility with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) is also provided but with spirometry function disabled.

The proposed Monitor B40V2.1 still has a 12.1 inch LCD display but is from different LCD manufacturer and LCD backlight is changed from CCFL to LED due to RoHS compliance.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 still includes features and subsystems that are optional or configurable. The proposed Patient Monitor B40V2.1 will continue interfacing to a variety of existing central station systems via a cabled network interface.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes a 510(k) premarket notification for a multi-parameter patient monitor (Monitor B40V2.1) and its substantial equivalence to a predicate device, the Monitor B40V2 (K130584).

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI/algorithm. Instead, the "acceptance criteria" are implied by the determination of "substantial equivalence" to a predicate device. The performance is assessed based on whether the changes made to the device have a significant impact on its ability to obtain patient measurements.

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

The document explicitly states: "The proposed Monitor B40V2.1 did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size and no data provenance mentioned for a clinical study related to this specific device (B40V2.1). The evaluation was based on non-clinical tests and a comparison to the predicate device.

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

Since no clinical studies were performed for the B40V2.1, there were no experts used to establish ground truth for a test set. The evaluation relies on the established safety and efficacy of the predicate device and the non-clinical assessment of the changes.

4. Adjudication method for the test set:

As no clinical test set was used, there was no adjudication method employed.

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 was done as this device is a multi-parameter patient monitor, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of AI assistance. The focus is on the device's ability to continuously monitor physiological parameters.

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

The device is a standalone multi-parameter patient monitor, meaning it operates to collect and display physiological data. However, the evaluation described is not a "standalone algorithm performance" study in the typical sense of AI, but rather a demonstration of the device's inherent functionality as a medical instrument. No specific algorithm-only performance study details are provided beyond the statement that "there are no changes to the parameter measuring hardware."

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

For the specific device (Monitor B40V2.1), no explicit ground truth based on expert consensus, pathology, or outcomes data was used because clinical studies were not required. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety of the predicate device (Monitor B40V2) and the assessment that the changes introduced did not alter these fundamental aspects. The non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) are intended to ensure the device performs as intended and meets relevant standards.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (patient monitor) and its modifications, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable for the same reason as above.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40V1 (K120598) platform. The proposed Monitor B40V2 provides additional support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) compared with predicate Monitor B40V1 (K120598). The proposed Monitor B40V2 is also compatible with CARESCAPE Respiratory modules (E-sCOV and EsCAiOV)(K123195) but with disabled spirometry function. The proposed Monitor B40V2 utilizes the existing 12 inch LCD display with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed Monitor B40V2 will continue to interface with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40V1, the proposed Monitor B40V2 includes features and subsystems that are optional or configurable. The proposed Monitor B40V2 interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V1, the proposed Monitor B40V2 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

This document describes the GE Monitor B40V2, a multi-parameter patient monitor. The primary focus of the provided text regarding acceptance criteria and studies is on the SpO2 accuracy performance for the neonatal patient population.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifically mentions an SpO2 accuracy performance study for the neonatal population. However, it does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges or statistical thresholds) within the provided text. It only reports that the study "demonstrated SpO2 accuracy performance."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Neonatal patient population" for the clinical study.
• Data Provenance: Not explicitly stated in the provided text regarding country of origin. The study was a "Clinical study of the GE SpO2 TruSignalV2 on Neonatal patient population." It is described as a prospective study since it was a "clinical study" performed "in accordance to ISO 14155-1, ISO14155-2, ISO9919 and FDA Guidance."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

Not explicitly stated in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical study for SpO2 accuracy in neonates, not a comparison of human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done. The clinical study was performed to demonstrate the "SpO2 accuracy performance of the TruSignal V2 technology on the neonate population," which implies an evaluation of the algorithm's performance independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy study would typically be established by a co-oximeter or a reference device known to precisely measure arterial oxygen saturation (SaO2) from blood samples. While not explicitly stated as "co-oximetry," clinical studies for SpO2 accuracy universally rely on such reference measurements.

8. The Sample Size for the Training Set

Not applicable/Not stated. The document refers to a clinical study for performance demonstration, not the training of an AI algorithm. The device primarily consists of a "TruSignal V2 algorithm" which is likely a fixed, developed algorithm, not one that undergoes continuous training in the context described.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not stated. As above, this document describes performance testing of a developed algorithm, not the training phase.

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The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The PROCARE Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.

The PROCARE Monitor B40 is not intended for use during MRI.

The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The PROCARE Monitor B40 is a multi-parameter patient monitor including both new and existing subsystems. The PROCARE Monitor B40 has a12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module). The PROCARE Monitor B40 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.

The PROCARE Monitor B40 includes features and subsystems that are optional or configurable. The PROCARE Monitor B40 interfaces to a variety of existing central station systems via a cabled network interface.

The provided text does not contain specific acceptance criteria or details about a study designed to prove the device's performance against such criteria. Instead, it refers to summaries of non-clinical tests and states that clinical studies were not required to support substantial equivalence.

Here's a breakdown of the information that is available and what is missing:

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

   • Missing. No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are listed for the PROCARE Monitor B40's performance. The document focuses on regulatory compliance and substantial equivalence to predicate devices rather than direct performance metrics against pre-defined criteria.

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

   • Missing. Since no clinical studies were performed, there is no test set or associated sample size discussed.

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

   • Missing. No expert-established ground truth is mentioned, as no clinical tests were conducted for this submission.

4. Adjudication method for the test set

   • Missing. Not applicable, as no test set requiring adjudication was used.

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

   • Missing. No MRMC study was done, as clinical studies were explicitly stated as "not required." 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

   • Missing. While the device contains algorithms (e.g., "identical arrhythmia algorithm, EK-Pro V12," and "identical NIBP hardware and SuperStat algorithm" to predicate devices), the document does not describe standalone performance studies for these algorithms. Performance is implied through substantial equivalence to predicate devices.

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

   • Missing. Not applicable, as no clinical studies requiring a ground truth were performed.

8. The sample size for the training set

   • Missing. The document mentions the device has "identical arrhythmia algorithm, EK-Pro V12" and "identical NIBP...SuperStat algorithm" as predicate devices, implying these algorithms were developed previously. However, details about the training sets for these algorithms are not provided in this submission for the PROCARE Monitor B40.

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

   • Missing. Similar to item 8, details on how the ground truth for the training sets of the existing algorithms (EK-Pro V12 and SuperStat) were established are not provided in this document.

Summary of Device Performance (based on provided text):

The PROCARE Monitor B40's performance is not evaluated directly against novel acceptance criteria in this submission. Instead, the submission argues for substantial equivalence based on the following:

• Technology: "The PROCARE Monitor B40 is a new monitor that essentially is a combination of the features and parameters of three existing predicate monitor platforms."
• Algorithms: It uses "identical arrhythmia algorithm, EK-Pro V12, as the CARESCAPE Monitor B650 (K102239)" and "identical NIBP hardware and SuperStat algorithm with CARESCAPE V100 Vital Signs Monitor (K073203)."
• Non-Clinical Tests: The device claims compliance with voluntary standards and underwent internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, module verification, system verification, validation, performance testing, safety testing).
• Conclusion: "GE Healthcare considers the PROCARE Monitor B40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices."

In essence, the "study" proving the device meets its acceptance criteria (which is substantial equivalence) is the comparison to predicate devices and adherence to design control and quality assurance processes, rather than a clinical trial with specific performance metrics.

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