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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, 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 B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), 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), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it 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 FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.

The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.

The monitor B125/B105 is not intended for use during MRI.

The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.

The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), 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 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), Cardiac output (C.O.) and Entropy.

The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed Monitor B125/B105 is a multi-parameter patient monitor that was developed based on predicate Monitor B125/B105 (K171580) to provide additional monitored parameters: Airway gases, Entropy and Cardiac output, by supporting additional optional modules previously cleared by FDA: CARESCAPE Respiratory module (K171028), Airway Ga Option N-CAiO(K151063), E-Entropy Module (K150298) (E-ENTROPY-01) and E-COP module (K052976) with extension interface rack and/or second frame(B1X5-F2).

In addition to the added parameters, the proposed Monitor B125/B105 offers several enhanced software features:

• Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult);
• Option called "Full Disclosure" to allow the display of parameter waveforms for up to 36 hours;
• National Early Warning Score (NEWS) calculation provided ;
• Additional printing capabilities to a remote recorder/Laser printer connected to a central station;
• Adoption of EK-Pro V14 ECG algorithm (previously cleared K191323) to support enhanced arrhythmia detection performance;
• Added Irregular, SV Tachy and Supra Ventricular Contraction (SVC), three more arrhythmia alarms;
• Enhanced parameter alarm priority adjustment/ configuration options,
• Cybersecurity enhancements.

The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size.

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It 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 document is a 510(k) Premarket Notification for the GE Medical Systems Information Technologies, Inc. Monitor B125/B105. It details the device's indications for use, its equivalence to predicate devices, and the non-clinical tests performed to support its substantial equivalence.

However, the document explicitly states in Section "14. Clinical (807.92(b)(2)): Summary of Clinical Tests:" that "the proposed Monitor B125/B105 did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them because:

• No clinical study was conducted. The submission relies on substantial equivalence to existing predicate devices and non-clinical testing.
• Acceptance criteria related to performance metrics for clinical outcomes (e.g., sensitivity, specificity for arrhythmia detection in a clinical trial setting with human readers) are not present in this document as no such clinical study was performed. The acceptance criteria for the device's performance would be related to its ability to accurately measure and display physiological parameters, which was assessed through non-clinical bench testing and comparison to predicate devices, not through a clinical trial with a test set of patient data and expert ground truth.

Because no clinical study was performed as part of this 510(k) submission, the requested information elements (1-9) which pertain to a clinical study evaluating device performance, cannot be extracted from this document. The document focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical performance, rather than providing results from a new clinical efficacy or effectiveness study.

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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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