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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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SedLine Sedation Monitor

The SedLine® Sedation Monitor is intended to monitor the state of the data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentany], Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors.

The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results.

SedLine Sensor

The RD SedLine Pediatric Sensor electrodes are applied directly to the patient's skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensors are indicated for pediatric patients (1 to 17 years).

The Masimo SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSi), EMG Index, Suppression Ratio (SR) and Artifact (ARTF).

The Masimo SedLine® Sedation Monitor includes the SedLine Module, SedLine EEG Sensor, and SedLine Patient Cable. The SedLine Module includes Masimo technology that processes the signal data collected from the SedLine sensor on the Host/Backboard device which provides the user interface.

This document specifies that the Masimo SedLine Sedation Monitor and Accessories (subject device) is substantially equivalent to the Masimo SedLine® Sedation Monitor (K172890) (predicate device). The key difference is the expansion of indications for use to include pediatric patients and the addition of pediatric sensors. The majority of the original acceptance criteria and performance data for the predicate device were maintained, with additional testing focusing on the new pediatric sensor and software verification for the expanded indications.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the specifications of the SedLine device and the pediatric sensor. These specifications effectively serve as acceptance criteria for the various features and functionalities of the device.

The "Reported Device Performance" for most criteria is implied by the statement "The testing was found to support the substantial equivalence of the subject device" and "The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met." For the pediatric sensor, specific dimensions and environmental specifications are provided.

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 for test sets for the performance of the device's main functionalities (EEG signal processing, PSi calculation, etc.). The non-clinical testing for the subject device focused on software verification/validation, mechanical, and environmental aspects related to the expansion of indications and pediatric sensor.

• Software Verification and Validation Testing: Conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005." The software was considered a "moderate" level of concern. No specific sample size or data provenance details are provided for this testing.
• Mechanical and Environmental Testing (Pediatric Sensor): Performed, but no specific sample size or data provenance details are provided.
• The document mentions that biocompatibility, wireless and cybersecurity, and human factors usability testing were not required for this submission as there were no changes to the materials, wireless capabilities, communication capabilities, or critical user-related tasks from the previously cleared predicate device (K172890). Therefore, the test data for these aspects would pertain to the predicate device and are not detailed here.

Overall, specific sample sizes and data provenance for the tests conducted for this submission are not explicitly stated.

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 provide information about the number or qualifications of experts used to establish ground truth for any test sets. The tests mentioned are primarily engineering/software verification and validation, and mechanical/environmental testing, which typically do not involve expert-established ground truth in the same way clinical studies might.

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

The document does not specify any adjudication methods for the test sets.

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 provided text. The device is a monitor that provides processed EEG data (including PSi), not an AI assisting human readers in interpretation like in diagnostic imaging.

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

The document describes the device as a "SedLine Sedation Monitor" that processes EEG signals to compute values like the Patient State Index (PSi). The PSi is "computed continuously from monitored changes in the QEEG when the sensor is applied." This indicates that the algorithm for generating PSi operates in a standalone manner, deriving its output directly from the EEG signals. The performance specifications for PSi (display range, resolution) are listed, and the overall non-clinical performance testing was conducted to ensure the device met its specifications. Therefore, the device's core algorithms operate in a "standalone" fashion on the incoming EEG data.

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

For the device's core functionality (PSi calculation related to anesthetic effect), the "ground truth" implicitly relates to the physiological changes in brain activity due to anesthetic agents. The PSi is described as "a proprietary computed EEG variable that is related to the effect of anesthetic agents" and "intended to provide information on the changes in sedation with the lower values reflecting lower levels of brain activity and deeper levels of sedation." The underlying validation of this relationship to actual anesthetic depth would have been established during the development and clearance of the predicate device. This document does not detail the specific ground truth used for that relationship.

For the current submission, the ground truth for the verification and validation (V&V) testing would be the predefined functional requirements, design specifications, and relevant standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).

8. The sample size for the training set

The document does not mention a training set or its sample size. The focus is on the verification and validation of the device's performance, not on the training of a machine learning model for a new diagnostic task. The PSi algorithm is described as "proprietary" and "computed continuously," suggesting a fixed algorithm rather than one that undergoes continuous training with new data.

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

Not applicable, as no training set is discussed in the document.

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