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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

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

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

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

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

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

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

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

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

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

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

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

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

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

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it can be mounted in a variety of ways (e.g., shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

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

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

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

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

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

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The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit.

The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:

1. Objective neuromuscular transmission monitoring
2. Subjective neuromuscular transmission monitoring

The continuous monitoring of NMT blocking involves electrical nerve stimulation and the measurement of acceleration in the corresponding muscle (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.

The device and all of the settings associated with it are designed for use on adult patients in hospital or health institutions so that the patient's curare level can be monitored.

The WiTOF system is composed of the station, the wireless sensor (hand), and the US AC power supply unit. The wireless sensor itself consists of the 3D accelerometer in the splint.

The WiTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice:

• TOF (Train Of Four)
• PTC (Post Tetanic Count)
• ATP (Automated TOF PTC)
• DBS (Double Burst) (3,3) (3,2)
• ST (Single Twitch) 0.1 Hz and 1 Hz
• TET (Tetanus) 50 Hz and 100 Hz

The station displays the various stimulation settings, the time elapsed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a display screen.

The accessories that can be used with the device include:

• Optic-serial (RS232) cable to transfer data
• Fixation clamp – regular size (10–40 mm / 0.4–1.6 inches)
• Fixation clamp – large size (20–60 mm / 0.8–2.4 inches)

The provided FDA 510(k) clearance letter for the WiTOF device does not contain the detailed performance study results, acceptance criteria, or specific data points typically found in clinical validation reports for AI/software-driven medical devices.

The document states that the software for the WiTOF device was considered of "moderate" level of concern and that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" However, it does not explicitly describe the acceptance criteria or the specific methodology/results of these tests.

Moreover, the letter explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness." This indicates that the regulatory clearance was based on demonstrating substantial equivalence primarily through technical comparison and non-clinical performance data (electrical safety, EMC, software V&V) rather than a comparative clinical study.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, because this level of detail is not present in the provided 510(k) clearance letter. The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed clinical validation study as might be conducted for novel AI algorithms.

If this were an AI/ML medical device submission requiring a detailed performance study, the 510(k) summary would typically include a section describing that study with the elements you've requested (e.g., sample size, ground truth establishment, reader studies). The absence of such a section, along with the statement that no animal or clinical testing was required, confirms that these specific study details are not part of this clearance document.

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The iTOF is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

The iTOF is an accelerometery based Quantitative Neuromuscular Blockade Monitor that provides continuous, non-invasive neuromuscular transmission (NMT) monitoring by measuring the acceleration of muscle movement (acceleromyography) during controlled electrical stimulations. The iTOF allows medical professionals to accurately monitor and evaluate the depth of neuromuscular blockade of an adult or paediatric patient in the intensive care ward, operating theatre, or recovery room. It is used by health professionals - anaesthesiologists, doctors, or fully qualified nurse anaesthetists for objective or subjective neuromuscular transmission monitoring. The iTOF system consists of a mobile device app (User Interface Software), a Bluetooth connected nerve stimulation device (Hardware and Firmware) powered by a 9 Volt nonrechargeable battery, an Accelerometer Sensor, and Stimulation Cables. The App displays user interface elements including the various stimulation settings controls, the time elapsed between stimulations (all modes), and the results for the measurements made in response to types of stimulation chosen by the user (TOF, PTC, and DBS) (TET and TWI responses are gauged visually by the health professional). The hardware device portion of the iTOF system provides the electrical stimulation patterns via the Stimulation Cables and quantitatively measures the resulting twitch via the Accelerometer Sensor. The iTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice: TOF (Train Of Four), PTC (Post Tetanic Count), DBS (Double Burst) (3.3), TWI (Single Twitch) (0.1Hz, 1 Hz, 2Hz), TET (Tetanus) (50Hz). The accessories that can be used with the device include: iTOF Splint (included).

The provided text does not contain information about specific acceptance criteria related to accuracy or performance metrics for the iTOF device. It primarily focuses on demonstrating substantial equivalence to a predicate device through functional, biocompatibility, electrical safety, wireless coexistence, software, and cybersecurity testing.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document indicates:

• No animal or clinical testing was required to demonstrate substantial equivalence, meaning no patient-level performance data is presented in this summary.
• Functional performance testing was performed on "output waveforms, voltage and current of different stimulation modes and simulated skin resistances." However, no specific metrics or acceptance criteria for these tests are provided.
• Software verification and validation testing was conducted, and the software was considered a "moderate" level of concern. No specific performance metrics or acceptance criteria for the software are detailed.
• The sample size for the training set and how its ground truth was established are not mentioned, as the document does not describe the development or training of any AI/ML components with performance metrics, but rather the verification and validation of software functionality.

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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.

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This device is a nerve stimulation device designed to be used by an anesthetist during:

1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.

2. Regional anesthesia, for the purpose of:

i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)

ii. nerve locating using invasive needles (not supplied)

The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.

The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.

The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.

In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.

The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).

The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.

The provided text describes the 510(k) premarket notification for the STIMPOD NMS450 Nerve Stimulator, focusing on its substantial equivalence to a predicate device (STIMPOD NMS450, K102084) and a reference device (Senzime, Tetragraph, K190795) with the addition of a new NMT Monitoring Cable (EMG) accessory.

However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria with detailed performance metrics. Instead, it states that "The subject device met or exceeded the stated acceptance criteria for each performance test." It then lists the types of performance tests conducted.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail specific sample sizes, ground truth establishment, or multi-reader multi-case study results, as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Reported Device Performance:

The document broadly states that the device met or exceeded acceptance criteria, but it does not provide the specific criteria or quantitative performance results.

Study Information (Based on available text):

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The text only lists the types of performance tests conducted, but not the specific methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The performance tests mentioned are primarily technical and engineering-focused (e.g., electrical safety, biocompatibility), which typically rely on standardized measurements rather than expert-established ground truth in the context of clinical interpretation.

4. Adjudication method for the test set:
   This information is not provided in the document.

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:
   This information is not applicable/provided. The device is an electrical peripheral nerve stimulator for monitoring neuromuscular blockade, not an AI-assisted diagnostic imaging tool with human readers. No MRMC study or AI-assistance evaluation is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable/provided in the context of an algorithm's performance. The device itself (STIMPOD NMS450 with the new EMG cable) performs measurements and stimulation; its "performance" is evaluated through the technical tests listed.

7. The type of ground truth used:
   For the technical performance tests mentioned (functional, electrical safety, EMC, biocompatibility, battery life, tensile strength, stimulation parameters), the ground truth would be established by engineering standards, specifications, and physical measurements rather than clinical ground truth like pathology or outcomes data. The document states that the device "met or exceeded the stated acceptance criteria," implying these criteria are based on defined technical standards and specifications.

8. The sample size for the training set:
   This information is not applicable/provided. The STIMPOD NMS450 is a hardware device with an accessory. There is no mention of a "training set" in the context of machine learning or AI models, as this is not an AI/ML powered device.

9. How the ground truth for the training set was established:
   This information is not applicable/provided as there is no mention of a training set or AI/ML components.

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The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, batteryoperated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph consists of the following main components: TetraGraph Monitor, TetraSens Electrode, TetraSens Pediatric Electrode (new accessory), Philips Interface (new and optional accessory), and Pole clamp kit (optional accessory).

The provided text describes the 510(k) premarket notification for the Senzime AB TetraGraph Neuromuscular Transmission Monitor, specifically for the addition of new accessories: the TetraSens Pediatric electrode and the Philips Interface. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (TetraGraph Neuromuscular Transmission Monitor, K190795).

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, summarized format. Instead, it refers to generalized performance testing.

However, it implicitly states that performance testing was conducted for the TetraGraph with the new TetraSens Pediatric electrodes and that "all of the acceptance criteria for this device" were met. These criteria are noted to be "the same or very similar to the predicate device's specifications."

The types of performance testing mentioned are:

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

The document does not specify the sample sizes used for any of the performance tests mentioned (biocompatibility, electrode testing, EMG detection, tensile strength, shelf life, software, electrical, EMC).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing conducted by the manufacturer or their designated testing facilities.

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 in the document. The tests described are largely bench-top and engineering performance tests, which typically do not involve experts to establish ground truth in the same way clinical studies or image-based diagnostics would.

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

This information is not applicable/not provided as the tests described are technical performance tests rather than clinical evaluations requiring adjudication of subjective outcomes.

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:

This type of study is not applicable and was not conducted. The device is a neuromuscular transmission monitor, not an AI-assisted diagnostic tool that aids human readers. The document explicitly states: "There was no clinical testing required to demonstrate that TetraGraph with the new TetraSens Pediatric electrodes is substantial equivalent to the predicate device as the predicate has similar technological characteristics."

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

The device itself is a measurement and monitoring device, an "algorithm only" or "standalone" performance would refer to its accuracy and reliability in measuring neuromuscular transmission. The performance testing (EMG evoked response detection, compliance with standards) serves this purpose by demonstrating the technical capabilities of the device in isolation, even though it's used by humans. The document confirms that "performance testing made for the device" was completed and met acceptance criteria.

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

For the described performance tests, the "ground truth" would be established by:

• Scientific Standards: For biocompatibility (ISO 10993-1) and electrode testing (ANSI/AAMI EC12: 2000), the ground truth is defined by the requirements and test methods outlined in these international and national standards.
• Engineering Specifications: For EMG evoked response detection, electrode tensile strength, and other performance tests, the ground truth is based on the device's design specifications and expected technical performance against which the measured results are compared.

8. The sample size for the training set:

This information is not applicable/not provided. The TetraGraph is a measurement device and the data provided does not suggest it uses machine learning or AI models that require a "training set" in the conventional sense. The submission focuses on hardware accessories and their technical performance.

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

This information is not applicable/not provided for the same reasons as in point 8.

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The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered. The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.

The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane and desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors and external devices which output analog voltage signal. The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® PT BSM-1700 Series Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), and Bispectral Index (BIS). The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.

AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems. The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.

The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical persomel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, or intensive care unit. NMT Module is a system comprised of NMT Module. Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array, and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. Thecaptured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are a lso sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. The operational setting is controlled via buttons on the module or a touch screen.

The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardial signs monitoring within a medical facility. The device is intended to produce a visualrecord of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is a lso intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU. HCU. NICU and an emergency room. These systems are placed near the patient and is intended to display patient's vital signs. These systems can also be connected to other external patient monitoring devices. In a ddition, these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients. The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit. The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The AY Series Input unit is used with the monitoring systems platforms, when connected to the core unit of the parent device, the inputunit collects electrical impulses, and the core units calculates and displays on the core unit's screen.

The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.
· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.
• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.
The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals. In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its.

Here's a breakdown of the acceptance criteria and related study information, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a detailed clinical study report proving performance against novel acceptance criteria. In this specific case, the submission emphasizes that there are no new acceptance criteria because the device (Life Scope PT BSM-1700 Series Bedside Monitor) is being updated to include a "standalone mode," but its underlying technology and performance characteristics are unchanged from its previously cleared version (K213316). Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the prior clearance and non-clinical testing for the updated mode.

1. Table of Acceptance Criteria and Reported Device Performance

Since the document explicitly states there are no new technological changes or safety/performance claims, the acceptance criteria are effectively the performance specifications of the predicate device (K213316). The reported device performance is stated to be "the same" as the predicate.

Study Proving Device Meets Acceptance Criteria

The document states:

• "The device performance and software have not changed from the original submission K213316." (Sections 2.4, 3.4, 4.4, 5.4)
• "For this submission the BSM-1700 Bedside Monitor has been updated to include the standalone mode. There are no specification changes, technological changes or safety and Performance claims. The indications for use and labeling have been updated to include the standalone mode." (Section 6)
• "The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, environmental, safety, and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device, the results confirmed that the device performed within specifications." (Section 6.3 Safety & Performance Tests)

Given this, the "study" is primarily an affirmation that the previously cleared performance for K213316 remains valid, coupled with non-clinical verification and validation testing of the additional "standalone mode" functionality to ensure it operates within the established specifications without altering the core performance characteristics.

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

   • The document does not specify a sample size for a clinical test set in this 510(k) summary. This type of submission relies heavily on non-clinical (bench) testing to confirm performance when significant changes are not made.
   • The data provenance is implied to be from Nihon Kohden's internal testing. The submission is focused on demonstrating substantial equivalence rather than presenting a de novo clinical study with patient data. As such, the data would be laboratory-generated from testing the device.

2. 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 because no clinical study requiring expert ground truth establishment for a test set is detailed. The "ground truth" for non-clinical performance would be derived from established engineering and metrological standards and test procedures.

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

   • This is not applicable since the submission focuses on non-clinical performance and engineering validation rather than human reader studies.

4. 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, an MRMC comparative effectiveness study was not done. This device is a physiological monitor, not an AI-powered diagnostic tool, and the submission does not mention AI assistance.

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

   • The term "standalone" in the provided document refers to a mode of operation for the BSM-1700 device, where it functions independently without being connected to a core unit. It does not refer to a standalone performance study of an algorithm.
   • However, the performance tests described in Section 6.3 were likely conducted in a "standalone" fashion for the device's functional parameters, meaning the device itself was tested to ensure its outputs (e.g., heart rate, SpO2 accuracy) met specifications. The submission highlights that "The device performance and software have not changed from the original submission K213316," implying that the standalone performance requirements were met by the previous device and confirmed for this update.

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

   • For the non-clinical testing, the ground truth would be based on calibrated reference standards and established measurement methodologies for physiological parameters (e.g., known electrical signals for ECG, certified NIBP simulators, calibrated temperature baths, etc.).
   • No clinical ground truth (like pathology or outcomes data) is described in this submission, as it's not a clinical study.

7. The sample size for the training set:

   • This information is not provided. Medical devices like this (physiological monitors) typically undergo engineering development, verification, and validation testing rather than a "training set" in the machine learning sense. Any underlying algorithms (e.g., for signal processing, arrhythmia detection) would have been developed and validated during earlier stages or for previous clearances.

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

   • Not applicable for this type of device and submission. If any algorithms involved "training," the ground truth would have been established using rigorously collected physiological data and expert annotation/labeling, but this detail is not present in the 510(k) summary.

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The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• · BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
• · C.O. monitoring and A-Fib are intended for adult patients only;
• · ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• · rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO₂), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment, whereas N1 configured with WMTS technology can be used inside the hospital only. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• . BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• BeneVision N19 Patient Monitor ●
• BeneVision N22 Patient Monitor ●
• BeneVision N1 Patient Monitor

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

This document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K202405).

The information provided primarily details the device's technical specifications and comparisons to a predicate device, rather than a full study proving the device meets acceptance criteria for a specific medical condition or AI diagnostic output.

Therefore, I cannot fully answer all parts of your request as the document does not contain the detailed clinical study results (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or specific AI performance metrics) that would typically be found for a device requiring those types of studies (e.g., an AI-powered diagnostic tool).

However, I can extract the relevant information regarding the device's functional and technical performance as demonstrated in this 510(k) submission.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are related to meeting the performance specifications of the predicate device and relevant consensus standards. The "reported device performance" is demonstrated through functional and system-level testing, ensuring the device meets its accuracy specifications for the various physiological parameters it monitors.

Table of "Acceptance Criteria" (Implied Specifications) and "Reported Device Performance" (Conformance):

Detailed Study Information (Based on Document Content):

1. Sample sizes used for the test set and the data provenance:

   • The document states that "functional and system level testing" and "bench testing" were conducted.
   • However, no specific sample sizes for test sets (e.g., number of patients, number of data recordings) are provided for any of the performance evaluations.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are generic "bench testing" to ensure compliance with technical specifications and standards, not clinical studies.

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

   • Not applicable / Not provided. This document describes engineering and bench testing against pre-defined technical specifications and industry standards for physiological measurement accuracy. It does not describe a clinical study involving human experts establishing ground truth for diagnostic interpretation (e.g., for an AI algorithm interpreting medical images).

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

   • Not applicable / Not provided. Same reason as above.

4. 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. This device is a patient monitor. It detects physiological parameters and provides alarms, and some interpretations of ECG (e.g., 12-lead ECG interpretation, arrhythmia detection). It is not an AI-assisted diagnostic device in the sense of image interpretation for which MRMC studies are typically performed. The document details that "optimized auditory ALARM SIGNALS" and "alarm highlight" were added, suggesting improvements to the human-device interface, but not a formal MRMC study on diagnostic improvement.

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

   • The document implies that algorithms for ECG (Mindray or Mortara algorithm for arrhythmia and ST-segment analysis) are embedded in the device. The listed accuracy specifications for these measurements (e.g., HR, ST, QT) reflect the standalone performance of these measurement algorithms and sensors against established benchmarks. However, a formal "standalone study" with detailed methodology, distinct from the general bench testing, is not specifically described or provided with separate results. The performance data listed (e.g., accuracy for HR, ST, QT) serves as the "standalone" performance verification for these integrated functionalities.

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

   • For physiological measurements (ECG, SpO2, NIBP, etc.), the "ground truth" would typically refer to reference measurement devices or calibrated simulators used during bench testing to verify the accuracy of the monitor's readings against a known, accurate value.
   • For the ECG interpretation (e.g., 12-lead ECG interpretation, arrhythmia detection), the ground truth for the algorithms would have been established during their development and previous clearance processes (Mindray or Mortara algorithms). This document focuses on demonstrating that the integration and revised features maintain that established accuracy rather than re-proving the core algorithms.

7. The sample size for the training set:

   • Not provided. This document pertains to the 510(k) clearance of updates to an existing patient monitor series. It does not detail the development or training of new AI/ML algorithms, which would typically involve substantial training datasets. The ECG algorithms (Mindray or Mortara) were presumably "trained" (or developed and validated) previously as part of their initial predicate clearances.

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

   • Not provided. (See point 7). For existing algorithms like Mortara or Mindray ECG algorithms, ground truth for their original development would likely have been established using large, diverse ECG databases with expert cardiologist interpretations and/or correlation with clinical outcomes where relevant. This particular 510(k) document is concerned with demonstrating equivalence and continued performance with minor changes, not the original algorithm development.

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The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

The Neuromuscular Transmission Monitor TOF3D is capable to monitor the level of neuromuscular transmission (NMT) during surgery of in the intensive care unit by stimulating different nerves and measuring the response of the respective muscles to the stimulation. The different locations for monitoring are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve/orbicularis oculi muscle. The Neuromuscular Transmission Monitor TOF3D uses acceleromyography (AMG) measurement for recording of evoked muscle responses. The results are shown on the LCD display of the device and shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.

The provided text is a 510(k) summary for the Neuromuscular Transmission Monitor TOF3D. It describes the device, its intended use, and its substantial equivalence to a predicate device (TOF-WATCH SX).

However, the document explicitly states that no animal or clinical testing was required to demonstrate substantial equivalence (Section 5.7, "Animal and Clinical Studies"). This means there is no study described in this document that proves the device meets acceptance criteria through clinical performance metrics, effect sizes, or expert evaluations. The acceptance criteria and performance data provided are related to non-clinical testing, such as electrical safety, EMC, software verification, validation, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical efficacy as requested in the prompt, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types for clinical use.

The available information about "acceptance criteria" and "device performance" in this document pertains to engineering and safety standards, not clinical effectiveness.

Here's what can be extracted regarding the non-clinical acceptance criteria and "performance":

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample sizes for the test set and data provenance:

• Not applicable for clinical performance studies. The testing was non-clinical (electrical safety, software, biocompatibility).

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

• Not applicable, as no clinical ground truth was established for performance testing.

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

• Not applicable, as no clinical ground truth was established for performance testing.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, explicitly stated that "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate."

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

• Not applicable, as the device is a hardware monitor, not an AI algorithm.

7. The type of ground truth used:

• For non-clinical testing, the "ground truth" was compliance with established engineering and safety standards (e.g., IEC standards, FDA software guidance, ISO biocompatibility standards).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable.

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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.

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