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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

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

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.

Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices. When Central Station is connected with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the Central Station can:
• Admit and discharge patients on the Nihon Kohden network.
• Display and manage compatible devices' real-time patient clinical data, vital signs, alarms and waveforms.
• Review and trend data calculated by connected Nihon Kohden devices.
• Store and transfer historical clinical data for the connected systems.
• Print patient data.

Central Station is intended for use in professional medical facilities by trained medical personnel.

Central Station is software only product that is installed on a Commercial Off the Shelf (COTS) Computer.

Central Station displays waveforms data and numerical data from a connected bedside monitor, vital sign telemeter, or multiple patient receiver unit on the screen.

Central Station is a network device, intended to provide remote patient monitoring to medical personnel. Central Station displays a list of measured values and a trend graph. Numerical data and various waveforms are color-coded for each parameter. Central Station also has the function of displaying an alarm.

Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment.

The provided document is a 510(k) clearance letter for the "Central Station" device. This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific performance acceptance criteria and study results in the same way as a full clinical trial report or a detailed design validation report would.

The document states:

• "Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices."
• "Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment."
• "The results of the substantial equivalence assessment, taken together with non-clinical bench testing, software verification, and validation demonstrate that the Central station does not raise concerns regarding its safety and effectiveness compared to its predicate device and operates in accordance with claimed indications for use."

Given these statements, the "Central Station" device is essentially a display, recording, and communication hub. It does not perform diagnostic algorithms or make independent judgments that would typically necessitate the kinds of detailed performance metrics (like sensitivity, specificity, or reader agreement) that are usually established through extensive multi-reader, multi-case (MRMC) studies with expert ground truth. Its primary function is to accurately display and relay data processed by other Nihon Kohden devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific device (Central Station) would primarily revolve around:

• Software Verification and Validation (V&V): Ensuring the software correctly displays, records, and transmits data as designed, and that all features (admit/discharge, trend display, printing, network communication) function as intended without errors.
• Non-Clinical Bench Testing: Confirming interoperability with compatible devices, accuracy of data display, alarm relay, and network functionality.
• Cybersecurity Compliance: Meeting regulatory requirements for cybersecurity.

The document explicitly states that "The software documentation was prepared following the FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (released June 14, 2023), specifically for an Enhanced Documentation Level." and "Verification testing was conducted at the system integration level to confirm that the device software fulfills its requirements and that safety and security risk mitigations, where applicable, were effective. Additionally, system-level testing was carried out to show that the software addresses user needs. All unit, integration, and system-level tests successfully met the test protocols."

Based on the provided text, it is not possible to extract the specific quantitative performance metrics (like sensitivity, specificity, or effect sizes for human readers) that would be relevant for a device performing complex data processing or diagnostic functions. The document emphasizes substantial equivalence and basic functional verification, not advanced AI/diagnostic performance validation.

However, I can infer the spirit of typical acceptance criteria and how a device like this would be proven to meet them, guided by the information provided.

Inferred Acceptance Criteria and Device Performance for "Central Station"

Given the device's stated function (display, record, print, and relay data without processing it for diagnosis or alarm judgment), the acceptance criteria would focus on functional correctness, data integrity, interoperability, and system reliability, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data for diagnostic algorithms, because the device doesn't perform diagnostic processing. The "test set" for this device would be a collection of test cases covering all functional requirements, interoperability scenarios with different compatible devices, alarm conditions (relayed), data storage limits, network loads, and user interaction flows. The document mentions "system integration level" and "system-level testing" and that "all unit, integration, and system-level tests successfully met the test protocols." This implies a comprehensive set of non-clinical, bench-level tests.
• Data Provenance: Not applicable in the sense of clinical patient data (e.g., from specific countries, retrospective/prospective studies), as the device does not process primary patient data for diagnosis. The data used for testing would be simulated, generated, or derived from compatible Nihon Kohden monitor outputs in a lab setting to verify the Central Station's display and communication functions.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable in the traditional sense for diagnostic AI. The ground truth for this device's performance would be the expected output based on its functional specifications and the known inputs from the connected Nihon Kohden devices. For example, if a connected monitor transmits an HR of 70 bpm, the ground truth is that the Central Station must display 70 bpm. These "ground truths" are established by engineering design specifications, not human expert consensus on clinical findings.
• Experts Involved: Software engineers, quality assurance engineers, subject matter experts on the physiological monitoring systems, and potentially clinical users for usability and workflow testing. Their qualifications would be in device design, software development, testing, and clinical application.

4. Adjudication Method for the Test Set

• Not Applicable in the context of clinical interpretation adjudication (e.g., 2+1 radiologist consensus). Adjudication in this context would be internal to the software development and testing process:
  • Test Pass/Fail Criteria: Predetermined pass/fail criteria for each test case.
  • Bug/Defect Resolution: Issues found during testing are logged as bugs, investigated by engineers, and resolved, followed by retesting.
  • Verification Sign-off: Test leads or design engineers review test results and formally sign off on the successful completion of verification.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, not performed for this device. An MRMC study is relevant for AI systems that assist human readers in making diagnostic decisions (e.g., radiologists reading X-rays with AI assistance). The Central Station device does not perform any such diagnostic assistance; it merely displays data from other (likely already cleared) devices. Its function is analogous to a monitor or a remote display unit, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This device does not have a "standalone algorithm" that performs diagnostic or data processing functions independently. Its function is entirely dependent on receiving data from other compatible Nihon Kohden devices.

7. Type of Ground Truth Used

• Functional Specifications and Truth from Connected Devices: The ground truth for this device is based on its functional design specifications (e.g., "display received data," "store data for X hours," "print Y parameters") and the verified output from the connected Nihon Kohden bedside monitors and telemetry systems. It's about data integrity and display accuracy, not clinical outcomes or pathology.

8. Sample Size for the Training Set

• Not Applicable. This device is described as "software only product" that "does not perform any data processing on the data received," and "Central Station itself does not have the function to perform alarm indication judgment." This strongly implies it is a rule-based or deterministic system, not a machine learning/AI system that requires a "training set" in the common sense (i.e., for learning patterns from data for prediction or classification). Therefore, there is no training set.

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

• Not Applicable. As there is no training set for an AI algorithm, there is no corresponding ground truth establishment process for a training set.

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The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds.

When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.

This is a clearance memo for a medical device and does not contain the detailed study information required to answer the prompt. Specifically, it states that "The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE View, Central Hub as compared to the predicate," followed by a list of general standards like electromagnetic compatibility testing, wireless coexistence testing, software verification and validation, usability testing, and cybersecurity evaluation. It also mentions "Verification of the ECG waveform display per IEC 60601-2-27:2011 and IEC 60601-2-47:2012" and "Verification of the alarm system to IEC 60601-1-8:2020," and "Performance evaluation of the HL7 FHIR and IEEE 11073 SDC communication."

However, it does not provide any specific quantitative acceptance criteria or detailed study results that would allow for a table of acceptance criteria vs. reported device performance, nor does it provide information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill the request using only the provided text. The document is a regulatory approval, not a clinical study report.

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hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals.

hinscope is intended for spot-check measurements, in adults, of:

• Non-Invasive blood pressure (NIBP) -
• -Pulse rate (PR)
• -Oxygen saturation (SpO2)

hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms. hinscope is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). hinscope is not a substitute for an ECG monitor.

hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

hinscope consists of the:

• hinscope measurement unit
• hinscope mobile application

hinscope consists of a vital sign measurement unit, that is positioned on the patient's upper arm, and a mobile application with a user interface which allows display of the vital sign data. hinscope is a combination of optical sensors and a sphygmomanometer cuff which provide measurements of the patient's pulse rate (PR) oxygen saturation (SpO2), and non-invasive blood pressure (NIBP).

PR and SpO2 are measured using a photoplethysmography (PPG) optical measurement method. PPG is a noninvasive technology that uses light sources (green, red and infrared) and photodetectors at the surface of skin to measure the volumetric variations of blood circulation. Blood pressured with the sphygmomanometer using an algorithm in which the cuff is slowly inflated while simultaneously sensing oscillations are no longer detected, the cuff deflates rapidly, and the signals are processed to determine systolic and diastolic pressures.

The vital sign measurement device communicates with a mobile application via wireless Bluetooth Low Energy (BLE) communication. The hinlab mobile application displays the blood pressure, SpO2 and pulse rate measurements.

Here's a breakdown of the acceptance criteria and study details for the Hinscope device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

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The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:

• Server Software Health Level seven (HL7) Interface Software Options -
• -American society for testing and materials (ASTM) Stat Lab interface
• -Developer Tools
• Pager Interface -
• -Alarm history database
• -Time master functions
• -12-lead electrocardiogram (ECG) export

Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.

The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow.

Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments.

Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems.

The subject device is compatible with Infinity Central Station Wide version VG5.0

This document is a 510(k) Premarket Notification from the FDA granting clearance for the Infinity Gateway Suite (VF9.1.1) from Draeger Medical Systems, Inc. It primarily addresses cybersecurity updates and other software improvements to an existing device.

Based on the provided text, the device is software only and does not involve AI/ML capabilities or diagnostic imaging. Therefore, most of the requested information regarding acceptance criteria, study methodologies (like multi-reader multi-case studies, standalone performance), ground truth establishment, expert adjudication, and sample sizes for training/test sets is not applicable in the context of typical AI/ML medical device submissions.

Here's a breakdown of the relevant information from the document as it pertains to the device's performance given its nature:

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

Since this is a software update primarily focused on cybersecurity and feature removal/modernization, traditional performance metrics like sensitivity, specificity, or accuracy (as seen in diagnostic AI devices) are not presented. The acceptance criteria relate to the successful implementation of the software updates and ensuring the device still functions as intended.

• ANSI AAMI ISO 14971:2019 (Risk Management)
• ANSI AAMI IEC 62304:2015 (Software Life Cycle Processes)
• ANSI AAMI IEC 62366-1:2020 (Usability Engineering) |

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

• Sample Size for Test Set: Not explicitly stated in terms of patient data or specific number of test cases, but the document mentions "All test cases were determined to meet their respective requirements," implying a set of defined test cases were executed.
• Data Provenance: Not applicable in the context of patient data as this is a software update for network communication and data exchange, not a device that processes or analyzes patient-derived data for diagnostic purposes. The testing is functional and performance testing of the software itself. The document does not specify country of origin for testing, nor whether it was retrospective or prospective, as these are not relevant to this type of software update.

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 is not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of software. The "ground truth" here is the expected behavior and functional requirements of the software, verified through standard software V&V processes.

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

• This is not applicable. Adjudication is typically used for ambiguous cases in clinical data annotation (e.g., differentiating between expert opinions on an image). For software functional testing, results are typically binary (pass/fail) based on predefined requirements.

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 is not applicable. The Infinity Gateway Suite is a data exchange and remote viewing software, not an AI/ML diagnostic or assistive device that would be used by human "readers" (e.g., radiologists, pathologists) to interpret medical images or data. Therefore, an MRMC study is irrelevant to this device.

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

• The device is a "standalone" algorithm in a sense that it performs its functions (data exchange, remote viewing) automatically. However, "standalone performance" usually refers to the diagnostic accuracy of an AI model on its own. Since this device doesn't perform diagnoses or predictions, this concept isn't directly relevant in the typical sense for AI. Its performance is about its functionality and interoperability.

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

• This is not applicable in the clinical sense. The "ground truth" for this software is its documented functional and cybersecurity requirements, against which the software's performance is verified.

8. The sample size for the training set:

• This is not applicable. The Infinity Gateway Suite is described as a software suite with specific functionalities (HL7 interface, Pager interface, data exchange, etc.) and cybersecurity updates. It is not an AI/ML model that undergoes a "training" phase with a dataset.

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

• This is not applicable for the same reason as point 8.

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Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:

• · Pulse rate
• · Respiration rate
• · Movement
• · Skin temperature

Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest.

Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

The Biofourmis Everion+ (G2) is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for patient monitoring.

The system is comprised of the following components:

• . Wearable device with multiple sensors
• . Secure cloud environment with an API
• Charger with accessories
• . Armband

The Everion+ G2 wearable is battery-operated with integrated sensors and wireless transceiver. The device is reusable and considered multi-patient use. After a healthcare professional (HCP) prescribes a device to a patient, they can clean the device according to the accompanying documentation for normal expected wear and buildup on the device. When the patient no longer needs the device for remote monitoring, the device can be returned to the HCP and undergo a low-level disinfection process, so it can be prescribed to a new patient.

The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The patient contacting components primarily involved in permanent contact are the bottom device housing and the armband. The wearable continuously gathers multiparameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver. When not in range, the collected data is stored on the Everion+ G2 wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from the cloud storage or integrated into a third-party application for monitoring.

I am sorry, but the provided text from the FDA 510(k) submission does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets them.

Specifically, the document lists:

• Indications for Use for the Biofourmis Everion+ (G2) for continuous monitoring of pulse rate, respiration rate, movement, skin temperature, and blood oxygen saturation (SpO2) in adults (18+) at rest in hospital or home environments.
• A Summary of Non-Clinical Tests indicating that the device met applicable standards for electrical, mechanical, thermal safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2, ANSI IEEE C63.27, AIM 7351731), packaging (ISTA 3A), biocompatibility (ISO 10993-1), and cleaning/disinfection (ISO 17664-2).
• A Summary of Animal & Clinical Studies mentions that SpO2 accuracy was assessed by comparing the device to arterial blood samples analyzed by CO-Oximetry, aiming for a root-mean-square (RMSE) comparison of no greater than 3.5% difference over a range of 70-100% SaO2, in accordance with ISO 80601-2-61 and FDA Guidance. It also mentions validation of skin temperature accuracy with laboratory test data per ISO 80601-2-56.

However, the document does not provide:

1. A table of specific acceptance criteria and the reported device performance for each vital sign, outside of the SpO2 RMSE target.
2. Sample sizes used for the test set (clinical studies) for SpO2, and other parameters like pulse rate, respiration rate, movement, or skin temperature. It only broadly mentions "multiple subjects."
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts and their qualifications for establishing ground truth.
5. Adjudication method.
6. Whether an MRMC comparative effectiveness study was done, or any effect size of human readers improving with AI assistance.
7. Whether a standalone (algorithm only) performance was done.
8. Type of ground truth for all parameters (beyond CO-Oximetry for SpO2, and "corresponding FDA cleared reference devices" generally).
9. Sample size for the training set.
10. How the ground truth for the training set was established.

The provided text focuses on demonstrating substantial equivalence to predicate devices and general compliance with regulatory standards, rather than a detailed breakdown of specific performance study results against defined acceptance criteria for each monitored parameter.

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The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.

The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.

The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.

The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):

• Pulse rate
• Oxygen saturation
• Temperature
• Movement

The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):

• Respiration rate.

The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:

• Non-invasive blood pressure
• Lung function & spirometry
• Weight

The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.

The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor.

The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.

The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.

Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.

The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).

The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The Corsano CardioWatch 287-2 System's acceptance criteria and studies are detailed below, primarily focusing on Pulse Rate, SpO2, Respiration Rate, and Skin Temperature.

1. Table of Acceptance Criteria and Reported Device Performance

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The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• Movement

The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of:

• · Respiration rate
• · Non-invasive blood pressure
• · Lung function & spirometry
• · Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.

The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the Current Health System, focusing on an age range extension. While it mentions the device's intended use and compares it to a predicate device, it explicitly states that "no animal or clinical performance data is included" (Page 11) and that "The performance of the modification is identical to the predicate and previously cleared device in terms of technical specification and safety." (Page 11).

Therefore, there is no study described that proves the device meets specific acceptance criteria through performance data, sample sizes, expert involvement, or ground truth establishment. The submission relies on the existing clearance of the predicate device for its performance claims.

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The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can:

• · Admit and discharge patients on the Nihon Kohden network.
• · Display and manage compatible devices' real-time patient clinical data.
• Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected.
• · Review and trend data calculated by connected Nihon Kohden devices.
• · Store and transfer historical clinical data for the connected systems.
• · Print patient data.

The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

The CNS-2101 central monitor is a central monitoring device designed to support medical personnel to provide medical care to multiple patients at the same time. It acquires vital sign data from multiple monitoring devices such as bedside monitors and displays the acquired data such as ECG and pulse rate on the screen as well as informing alarms.

The CNS-2101 can communicate with other devices through a network connection. The CNS-2101 can acquire vital sign data directly from multiple monitoring devices (e.g., bedside monitors) connected to Nihon Kohen Monitoring device network or using multiple patient receivers and transmitters, or by a combination of both methods. The parameters to monitor on the central monitor can be changed as necessary by selecting a monitoring device such as a bedside monitor or transmitter and changing the parameter settings for that device.

The CNS-2101 is designed to be installed in a location outside the patient environment such as a nurse's station for central monitoring.

The provided text is a 510(k) summary for the Nihon Kohden CNS-2101 Central Monitor. This document focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not present specific acceptance criteria with numeric performance values or detailed performance study results in the way typically found for AI/ML-driven devices with diagnostic or prognostic claims.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document states that the device was tested according to international and FDA-recognized consensus standards to verify and validate its functionality and technical characteristics. However, specific performance metrics (e.g., sensitivity, specificity, accuracy) are not listed for the CNS-2101.

2. Sample size used for the test set and the data provenance: This information is not provided. The testing described is verification and validation (V&V) against design specifications and consensus standards, not clinical performance testing with patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and therefore not provided. "Ground truth" in the context of diagnostic accuracy is not relevant to the described V&V testing of a central monitoring system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and therefore not provided.

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 and therefore not provided. The CNS-2101 is a central monitoring system that displays data from other devices; it does not utilize AI to assist human readers in interpretation or diagnosis.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable and therefore not provided. The CNS-2101 is a networked multi-patient monitoring system, not a standalone diagnostic algorithm. It displays data from already cleared bedside monitors and telemetry systems. It "does not perform any data processing on the data received from the Nihon Kohden compatible devices."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable and therefore not provided, as the testing relates to the functional performance and safety of the system rather than diagnostic accuracy against a specific condition.

8. The sample size for the training set: Not applicable and therefore not provided. The document describes a central monitoring system, not an AI/ML device that requires training data.

9. How the ground truth for the training set was established: Not applicable and therefore not provided.

Summary of available information regarding performance:

• Acceptance Criteria: Not explicitly defined with performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied by adherence to recognized consensus standards for medical electrical equipment, software lifecycle, risk management, usability, electromagnetic compatibility, and alarm systems.
• Study Proving Device Meets Acceptance Criteria: Non-clinical verification and validation testing was conducted on the CNS-2101 based on the following standards and guidance:
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • IEC 62304:2006/A1:2015 Medical device software - Software life cycle processes
  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • ANSI/AAMI/IEC 62366-1:2015 Medical devices -Part 1: Application of usability engineering to medical devices.
  • Various FDA guidance documents related to software validation, cybersecurity, interoperable medical devices, off-the-shelf software, EMC, and human factors.
• Reported Device Performance: The document states that "All function in the CNS-2101 have been validated by the FDA-recognized consensus standards, therefore, the validity of the results can be ensured." It also notes that "Tests conducted within the software development cycle demonstrate that communication between the CNS-2101 and the Nihon Kohden 510(k)-cleared monitoring devices is robust and stable enough to exchange accurate physiological data in real time."

In essence, the document confirms that the CNS-2101 complies with relevant safety and performance standards for its intended function as a central monitoring system, without requiring a clinical validity study involving comparison to a "ground truth" or expert adjudication for diagnostic accuracy.

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Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:

• Pulse rate
• Respiration rate
• Movement
  The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring.
The system is comprised of the following components:

• Wearable device with multiple sensors
• Secure cloud environment with an API .
• Charger with accessories .
• Armband .
  The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver.

Here's a breakdown of the acceptance criteria and study information for the Everion+ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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