Search Results

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.

Ask a specific question about this device

Indications for Use for CARESCAPE Canvas 1000:

CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas 1000 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.

CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE Canvas 1000 is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas Smart Display:

CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas Smart Display is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and · respiratory (impedance respiration, airway gases (CO2)

CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.

CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas D19:

CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.

CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.

Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.

Indications for Use for F2 Frame; F2-01:

The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.

The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.

The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission.

CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately).

For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01).

The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.

Please note that the provided text is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to various standards. It explicitly states that clinical studies were not required to support substantial equivalence. Therefore, some of the requested information regarding clinical studies, human expert involvement, and ground truth establishment from patient data will likely not be present.

Based on the provided text, here's the information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific, quantifiable acceptance criteria alongside reported performance data. Instead, it states that various tests were conducted to demonstrate that the design meets specifications and complies with consensus standards. The performance is generally reported as "meets the specifications," "meets the EMC requirements," "meets the electrical safety requirements," and "fulfilled through compliance."

However, we can infer some "acceptance criteria" based on the standards and tests mentioned:

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

• Test Set Sample Size: The document implies that the "test set" for performance evaluation was the device itself and its components as described ("CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01)").
  • For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" were involved.
• Data Provenance: The testing described is non-clinical bench testing.
  • For usability testing, the users were located in the US.
  • No direct patient data or retrospective/prospective study data is mentioned beyond the device's inherent functional characteristics being tested according to standards.

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

• Number of Experts: Not applicable in the context of establishing "ground truth" for patient data, as no clinical studies with patient data requiring expert adjudication were conducted or reported to establish substantial equivalence.
• For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" participated. Their specific qualifications (e.g., years of experience, types of healthcare professionals) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical studies with patient data requiring adjudication were conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC study was done, as the document explicitly states: "The subjects of this premarket submission... did not require clinical studies to support substantial equivalence." The device is a patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar.

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

• The performance evaluations mentioned (e.g., for general device functionality, electrical safety, EMC, specific parameter measurements like ECG/arrhythmia detection) represent the device's standalone performance in a bench setting, demonstrating its adherence to established standards and specifications. There is no separate "algorithm only" performance study reported distinctly from integrated device testing. The EK-Pro V14 algorithm, which is part of the device, is noted as "identical" to the predicate, implying its performance characteristics are maintained.

7. The Type of Ground Truth Used

• For the non-clinical bench testing, the "ground truth" was established by conformance to internationally recognized performance and safety standards (e.g., IEC, ISO, AAMI/ANSI) and the engineering specifications of the device/predicate. These standards define the acceptable range of performance for various parameters.
• For usability testing, the "ground truth" was the successful completion of tasks and overall user feedback/satisfaction as assessed by human factors evaluation methods.
• No ground truth from expert consensus on patient data, pathology, or outcomes data was used, as clinical studies were not required.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a patient monitor, not a machine learning or AI model trained on a dataset. The device contains "Platform Software that has been updated from version 3.2 to version 3.3," but this refers to traditional software development and not a machine learning model requiring a "training set" in the AI sense.

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

• Not applicable, as there is no mention of a "training set" in the context of machine learning. The software development likely followed conventional software engineering practices, with ground truth established through design specifications, requirements, and verification/validation testing.

Ask a specific question about this device

The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.

The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE B650:

The CARESCAPE B650 is not intended for use in a controlled MR environment.

CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.

The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.

Here's a breakdown of what can and cannot be extracted based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.

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

This information is not provided in the document. The document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.

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)

This information is not provided. As this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."

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" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.

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

Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:

• Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
• Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.

However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

• · hemodynamic (including ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
• · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
• · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

CARESCAPE B850 is a new version of a modular multi- parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 includes features and subsystems that are optional or configurable.

This looks like a 510(k) summary for the GE Healthcare CARESCAPE B850 patient monitor. I will extract information related to the acceptance criteria and study that proves the device meets them.

Based on the provided text, the CARESCAPE B850 is a multi-parameter patient monitor. The 510(k) submission is for a new version with updated software and minor hardware modifications. The submission refers to a primary predicate device, also named CARESCAPE B850 (K191323), and additional predicate/reference devices for specific parameters (INVOS PM7100 and MASIMO RADICAL Y PULSE CO-OXIMETER).

The key takeaway is that the device did not require clinical studies to support substantial equivalence because it is a modified version of an already cleared device and incorporates previously cleared parameters. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the new CARESCAPE B850 compared to a specific threshold. Instead, it relies on the concept of substantial equivalence to a predicate device.

The "acceptance criteria" are implied to be that the performance of the new device is "as safe, as effective, and the performance to be substantially equivalent to the predicate device." The reported "device performance" is primarily that it passed various non-clinical tests.

Implied Acceptance Criteria (based on substantial equivalence concept):

Note: The document states that the fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to its predicate (K191323), except for the addition of an E-musb Interface module and the capability to display previously cleared hemodynamic parameters from OEM devices (regional oxygen saturation and total hemoglobin concentration).

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing related to software, hardware and performance." This typically involves testing prototypes or production units, but a "sample size" in the context of patient data is not applicable here as no clinical studies were performed for this submission.
• Data Provenance: Not applicable, as no external data (e.g., patient data from a specific country, retrospective or prospective) was used for this 510(k) submission to demonstrate substantial equivalence. The testing was internal bench testing.

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

• Number of Experts: Not applicable. For bench testing of hardware and software, "ground truth" is typically established by engineering specifications, validated test protocols, and adherence to consensus standards, rather than expert clinical consensus on patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies to clinical studies where discrepancies in observations or diagnoses need to be resolved. For bench testing, test results are typically compared against predefined specifications.

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

• MRMC Study: No. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The new version mostly focuses on software updates, minor hardware changes, and display of previously cleared parameters from other OEM devices.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The core functionality of the device (e.g., ECG, arrhythmia detection, various physiological measurements) operates in a "standalone" fashion in that the algorithms process patient data collected by the sensors. The document doesn't detail specific "algorithm-only" performance metrics as would be seen for a novel AI algorithm. Instead, it relies on the previous clearance of the predicate device and the fact that the algorithms (like EK-Pro arrhythmia detection algorithm V14) are identical. The newly added parameters (regional oxygen saturation and total hemoglobin concentration) are sourced from OEM devices that would have their own standalone performance data from their original clearances.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical bench testing, the ground truth would be the engineering specifications of the device and adherence to relevant consensus standards (e.g., for electromagnetic compatibility, electrical safety, environmental performance). For the physiological parameters, the "ground truth" for the algorithms (e.g., arrhythmia detection) was established during the development and clearance of the predicate device (K191323) and the OEM devices for rSO2 and SpHb.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device that requires a distinct "training set" for model development for this 510(k) submission, this information is not relevant here. The update involves existing algorithms and integration of existing cleared parameters.

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

• How Ground Truth for Training Set Was Established: Not applicable, for the same reason as point 8.

Ask a specific question about this device

The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility

CARESCAPE B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 includes features and subsystems that are optional or configurable.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document describes the CARESCAPE B450, a multiparameter patient monitor. This submission is for a new version of the device, primarily focusing on updated software and minor hardware modifications.

The document does not contain details about specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or a study proving the device meets those criteria with statistical significance. Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device (K191249 CARESCAPE B450) and compliance with general safety and performance standards through non-clinical testing.

Here's a breakdown of the requested information based on the available text:

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

   This information is not explicitly provided in the document. The submission aims to show that the new CARESCAPE B450, with its updated software and minor hardware, is "substantially equivalent" to its predicate device. This implies that its performance is expected to meet the same standards as the predicate, but specific performance metrics and acceptance thresholds for those metrics are not detailed.

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

   This information is not provided. The document states that "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications." It also notes that "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This indicates that the primary validation was through non-clinical bench testing, not through studies on patient data.

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)

   This information is not provided. As clinical studies were not required and the validation was primarily non-clinical bench testing, the concept of "ground truth" derived from expert consensus on patient data (as would be typical for AI/ML performance studies) is not applicable or described in this document.

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

   This information is not provided. Since no clinical studies or evaluations of diagnostic performance against a "ground truth" established by experts on a test set are detailed, adjudication methods are not mentioned.

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 or reported. The device is a patient monitor with arrhythmia detection, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

   The document states that "Bench testing related to software, hardware and performance... was conducted," implying that the device's inherent functional performance was tested. The phrase "algorithm only" isn't explicitly used, but the testing would effectively assess the device's standalone operation. However, no specific performance metrics (like those one would expect for an AI algorithm, e.g., sensitivity/specificity for specific arrhythmias) are reported. The device features "EK-Pro arrhythmia detection algorithm EK-Pro V14", and its performance is assumed to be equivalent to the predicate using the same algorithm version.

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

   For the non-clinical bench testing, the "ground truth" would likely be based on established engineering specifications, simulated physiological signals, and validated test protocols inherent to medical device performance testing, rather than expert consensus, pathology, or outcomes data from human subjects. This type of detail is not further elaborated in the document.

8. The sample size for the training set

   This information is not provided. As the submission is for a new version of an existing device primarily involving software updates and minor hardware changes, and the algorithm (EK-Pro V14) itself is listed as "Identical" to the predicate, details about a training set for a new or significantly retrained algorithm are not discussed.

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

   This information is not provided, for the same reasons as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

Ask a specific question about this device

The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

· hemodynamic (including ECC, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

The CARESCAPE B850 is a new version of a modular multi-parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.

The provided document, [K191323](https://510k.innolitics.com/search/K191323), is a 510(k) premarket notification for the GE Healthcare CARESCAPE B850 patient monitor. It describes the device and compares it to a predicate device ([K131414](https://510k.innolitics.com/search/K131414) CARESCAPE Monitor B850). This document outlines non-clinical testing and explicitly states that clinical studies were not required.

Therefore, I cannot fully answer your request for acceptance criteria and a study proving the device meets those criteria from this specific document, as it indicates clinical studies were not performed. The document focuses on demonstrating substantial equivalence through non-clinical bench testing, including software, hardware, and performance tests, and usability studies.

However, I can extract the information related to the device's performance and the types of tests conducted, even if they aren't presented as a structured "acceptance criteria" table with "reported device performance" against them in a clinical study context.

Here's a breakdown of what can be extracted and what cannot:

What Can Be Inferred/Extracted from the Document:

• Device Performance (as demonstrated by non-clinical testing):

  • The CARESCAPE B850's hardware, software, and overall performance met specifications through bench testing.
  • The device demonstrated electromagnetic compatibility, electrical safety, environmental resilience, and usability.
  • Software testing covered design, development, verification, validation, and traceability.
  • The device addressed patient safety, security, and privacy risks, including cybersecurity measures.
  • It can withstand network storm conditions without rebooting.

• Test Set Description (for non-clinical testing):

  • Data Provenance: Not explicitly stated for specific datasets, but testing was conducted on the aformentioned device, manufactured by GE Healthcare Finland Oy. This implies internal testing. The nature of "bench testing" suggests controlled environments rather than real-world patient data for performance validation against specific clinical thresholds.
  • Retrospective/Prospective: Not specified. Bench testing is typically a controlled laboratory process.

• Ground Truth (for non-clinical testing):

  • The "ground truth" for the technical specifications and performance of the device (e.g., accuracy of parameter measurements, robust alarms) would have been established by engineering and quality standards, internal specifications, and applicable consensus standards (e.g., IEC 60601-1-8 for alarms).

What Cannot Be Answered From the Document (specifically regarding clinical studies/acceptance criteria as implied by clinical outcomes or human reader performance):

1. A table of acceptance criteria and the reported device performance (in a clinical context): The document explicitly states "CARESCAPE B850 did not require clinical studies to support substantial equivalence." Therefore, no clinical performance acceptance criteria or reported clinical performance is provided. The acceptance criteria for the non-clinical tests are implicit in the statement "demonstrating the design meets the specifications" for hardware, software, and performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical study: Not applicable, as no clinical study was performed.

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, as no clinical study was performed. Ground truth for technical performance would be against engineering benchmarks, not expert clinical assessment in a study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.

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 for image interpretation or similar. The "EK-Pro arrhythmia detection algorithm" is an internal algorithm, not a separate AI for human assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The EK-Pro V14 arrhythmia analysis algorithm operates within the device as a standalone component for its intended function. Its performance would have been validated against a set of ECG waveforms with established ground truth for arrhythmias, but details of such testing (like sample size or specific metrics) are not in this 510(k) summary. The document states "EK-Pro V14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors," implying internal validation of the updated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the arrhythmia detection algorithm, the ground truth would typically be established by expert cardiologists reviewing ECG recordings. However, the details of how EK-Pro V14's ground truth was established are not provided in this 510(k). For general device performance, the ground truth is adherence to technical specifications and relevant standards.

8. The sample size for the training set: Not applicable, as this is a 510(k) submission for a patient monitor, not an AI/ML device requiring a training set in the typical sense. While the EK-Pro algorithm may have been "trained" or developed using data, the document does not mention details about this.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary Table of Available Information (based on non-clinical context):

Conclusion from Document:

The acceptance criteria for the CARESCAPE B850, as presented in this 510(k) submission, were met through extensive non-clinical bench testing, hardware and software verification/validation, and usability studies. The submission asserts the device's substantial equivalence to its predicate based on these non-clinical activities, stating explicitly that clinical studies were not required or performed.

Ask a specific question about this device

The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility.

The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.

The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE B450 V3 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 V3 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software version 3 and one or two batteries. CARESCAPE B450 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 V3 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 V3 includes features and subsystems that are optional or configurable.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the CARESCAPE B450, based on the information provided in the 510(k) summary.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the novel aspects. Therefore, much of the requested information (like specific quantitative acceptance criteria or detailed study methodologies for new features) is not explicitly present. The summary explicitly states that no clinical studies were required to support substantial equivalence for this particular submission.

Acceptance Criteria and Device Performance for CARESCAPE B450

Given that this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance outlined refers to the device's ability to maintain existing functionalities and integrate new ones without compromising safety or efficacy, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit, quantitative acceptance criteria for each individual parameter for this 510(k) are not provided in the document (as it's a "substantial equivalence" claim based on existing technology), the table below reflects what can be inferred. The "acceptance criteria" here are largely implicit: that the new device performs equivalently or better than the predicate, or that new features function as intended and safely.

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

• Sample Size: Not explicitly stated in the 510(k) summary for specific performance tests. The review relies on "bench testing" and "extensive usability work" without providing specific numbers of test cases, patients, or data points.
• Data Provenance: Not explicitly stated. The nature of "bench testing" suggests a controlled, laboratory environment. For usability, it would involve participants, but their origin is not specified. The arrhythmia algorithm (EK-Pro V14) likely draws from large, existing ECG databases typically used in device development, but this is not detailed here.

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

• Number of Experts & Qualifications: Not specified in the provided text. For arrhythmia algorithms (EK-Pro), ground truth is typically established by multiple cardiologists or electrophysiologists. However, for this 510(k), since the EK-Pro V14 is considered "equivalent" to a previously cleared version, the detailed ground truth establishment for it is likely from prior submissions or internal development, not explicitly reported here.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For tasks like arrhythmia detection, typically multiple experts review and label data, and disagreements are resolved through consensus, majority vote, or a super-reader.

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:

• MRMC Study: No. The document explicitly states: "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This means no clinical MRMC studies were conducted for this submission. The device is a patient monitor, not primarily an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: The document does not explicitly present a standalone performance study for the EK-Pro V14 arrhythmia algorithm. It states that EK-Pro V14 is an update to V13 and is "equivalent." Implied is that internal validation of the algorithm's performance against ground truth would have occurred during its development, but the results are not detailed in this 510(k) summary. The gas exchange parameters are also noted as "identical" in calculation to previously cleared predicate devices, implying their standalone performance is already established.

7. The Type of Ground Truth Used:

• Ground Truth Type: Not explicitly stated for any of the tested features within this document.
  • For Arrhythmia Detection (EK-Pro V14): Typically, expert-annotated ECG waveforms (clinical data) serve as ground truth.
  • For Gas Exchange Parameters: Likely derived from high-precision laboratory measurements or established physiological models.
  • For Hardware/Software Functional Testing: System specifications and expected behavior as defined during development serve as ground truth.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not specified. Training sets are primarily relevant for machine learning algorithms. While the EK-Pro algorithm may have some adaptive or learning components from its development, the document doesn't detail its training set.

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

• Ground Truth Establishment for Training Set: Not specified. As mentioned above, for arrhythmia detection, this would typically involve expert cardiological review and annotation of large datasets.

Ask a specific question about this device