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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, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

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

The monitor B105M, 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 noninvasive blood pressure (systolic 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/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).

The monitor B105M, B125M, B105P and B125P are 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, 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 multi-parameter patient monitors that were developed based on predicate Monitor B125/B105(K201941) to provide additional monitored parameter: neuromuscular transmission (NMT), by supporting additional optional modules previously cleared by FDA: E-NMT module (K051635) with existing interface rack and/or second frame (B1X5-F2).

In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:

• Support 12-lead ECG measurement mode;
• Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
• Enabled the Impedance Respiration measurement from lead RL-LL:
• Display Pulse Rate (PR) from NIBP when performing NIBP determination;
• Display real-time GE SpO2 Perfusion Index (PI) value; .
• Adoption of TruSignal V3 SpO2 algorithm;
• Additional optimizing IBP waveform scale function;
• Additional connectivity capabilities within GE CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
• Additional remote service function:
• Additional cybersecurity enhancements.

The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation.

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.

As with the predicate Monitor B125/B105 (K201941), 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 whic include CO2 and Gases 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), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC.

In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)

Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P 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 an FDA 510(k) Premarket Notification for a patient monitor. It does not describe a study involving an AI-driven device or an equivalent. Therefore, I cannot extract the information required to answer your prompt, as the prompt is geared towards AI/ML-based medical devices with specific performance metrics and validation studies.

The document focuses on demonstrating substantial equivalence of the new monitor models (B105M, B125M, B155M, B105P, B125P) to existing predicate devices (Monitor B125/B105, CARESCAPE B450, CARESCAPE VC150, CARESCAPE ONE). The changes primarily involve physical design, software enhancements (display modes, calculation additions, connectivity), and support for an additional, previously cleared, NMT measurement module. The document explicitly states:

"The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence." (Page 16)

This indicates that the device's performance was evaluated through bench testing, cybersecurity assessments, and verification of software and hardware changes against established standards, rather than through comparative effectiveness studies with human readers or standalone algorithm performance studies typical for AI/ML devices. Therefore, a table of acceptance criteria and proven performance for an AI/ML component, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable or present in this document.

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The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.

The CARESCAPE SpO2 - Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

The CARESCAPE SpO2 - Masimo is equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.

The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).

The provided text describes the CARESCAPE SpO2 - Masimo device, whose 510(k) submission (K212876) is for a labeling update and to market the device under its own 510(k). The device itself is identical to the primary predicate device, GE CARESCAPE SpO2 – Masimo (part of K200494), with no changes to hardware, software, or performance. Therefore, new performance data was not generated for this submission.

The acceptance criteria provided in the document are the performance specifications of the device as previously cleared with the predicate device.

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

Since this submission is for a device that is identical to a previously cleared predicate, the "reported device performance" refers to the previously established performance specifications which are considered met, as there are no changes to the device itself.

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

The document explicitly states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence."

Therefore, no new test set was used for this particular submission. The performance data is derived from the testing conducted for the primary predicate device (K200494), but the details of that testing (sample size, data provenance) are not provided in this document.

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

Not applicable for this submission as no new testing was performed to establish ground truth.

4. Adjudication method for the test set

Not applicable for this submission as no new testing was performed to establish ground truth that would require adjudication.

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 an oximeter, not an AI-assisted diagnostic tool.

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

The performance specifications listed are standalone performance metrics of the oximeter device. Details of the studies establishing these specifications were conducted for the predicate device, but are not described in this document.

7. The type of ground truth used

For an oximeter measuring SpO2 and Pulse Rate, the ground truth typically involves invasive blood gas analysis (for SpO2) and ECG or simultaneous direct measurement (for Pulse Rate) against which the device's measurements are compared. These methods would have been used during the original testing of the predicate device.

8. The sample size for the training set

Not applicable. This document is for a medical device (oximeter), not an AI model requiring a training set. The device operates on physical principles, not machine learning.

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

Not applicable.

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