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The Nihon Kohden Vital Sign Telemeters GZ-120P and GZ-130P are intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. Both GZ-120P and GZ-130P transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO₂) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor.

The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

The Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P is mainly used as a telemetry system within a medical facility. The device transmits patient's vital signs (ECG, SpO2*, respiration, pulse waveform) and alarm information via wireless LAN connection to the central monitoring station. The device can be configured to display the patient's vital signs on the screen and generate alarms for use as a temporary simple monitor. *SpO2 is for GZ-130P only.

The provided text describes the Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P and details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel algorithm's performance. The document focuses on regulatory approval based on safety, essential performance, and equivalence to existing devices.

Therefore, many of the requested categories regarding algorithm-specific performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a hardware device with monitoring capabilities, not an AI/algorithm-driven diagnostic/decision-support tool.

However, I can extract information related to the device's general performance and the types of tests conducted for its regulatory approval.

Here's the information based on your request, with an emphasis on what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the context of an algorithm's diagnostic accuracy. Instead, it refers to compliance with safety and performance standards.

Implicit "Acceptance Criteria" (Compliance with Standards) and "Reported Performance" (Validation of Compliance):

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

The document does not specify a "sample size" in terms of number of patients or physiological recordings for evaluating performance of an algorithm. The testing described is primarily related to engineering and regulatory compliance of the device itself (hardware, software, communication protocols). Therefore, data provenance is not discussed in terms of country of origin or retrospective/prospective collection as there isn't patient data being evaluated for a diagnostic algorithm.

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

Not applicable. This document describes the regulatory clearance for a vital sign telemeter, which transmits physiological data (ECG, respiration, SpO2) and generates alarms. It does not involve a diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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. The device is a monitor and telemeter, not an AI-assisted diagnostic tool that would involve human readers and their improvement with AI assistance.

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

The document does not describe a standalone algorithm performance study. The device itself performs functions like arrhythmia detection and alarm generation, but these are inherent to the monitor's functionality, not a separate "algorithm" requiring a standalone performance study. Its performance for these functions is indicated as being "equivalent to the predicate device."

7. The Type of Ground Truth Used

Not applicable in the context of an algorithm's diagnostic accuracy. The "ground truth" here would relate to the accuracy of the physiological measurements themselves against calibrated standards, and the proper functioning of alarms as per specifications and standards. This is implied by the "Test Summary" and "Standards compliance testing" sections.

8. The Sample Size for the Training Set

Not applicable. This device is not described as having an AI algorithm that requires a training set of data.

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

Not applicable for the reasons stated above.

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The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied.

The device is not to be used in the presence of flammable anesthetic agents or other iqnition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate intra-hospital transport. The HAMILTON-G5's pneumatics deliver gas -- while its electrical systems controls pneumatics, monitors alarms and distributes power. The user interface consists of a LCD-display with touch screen, keys, and a press-and- turn knob.

The HAMILTON-G5's new software version 2.30, includes a pulse oximetry function for continuous, non-invasive oxygen saturation monitoring (SpO2).

Volume targeting in the HAMILTON-G5 is now supported by a new ventilation mode, called the Volume Support mode (VS). It is a flow-cycled, volume targeted, and pressure-regulated mode.

The Volume Support (VS) mode is designed for spontaneously breathing patients. It provides support to patient-initiated breaths so as to deliver the desired tidal volume (V+), at a level appropriate to the patient's efforts. This mode allows the ventilator to change the support in response to changing patient conditions and inspiratory effort levels. To achieve this volume, the device decreases support when the patient's breathing activity increases or, conversely, increases support when the patient's inspiratory effort decreases.

Here's an analysis of the acceptance criteria and study information for the HAMILTON-G5 device, based on the provided document:

The document is a 510(k) summary for the HAMILTON-G5 ventilator, specifically for an updated version (SW 2.30) that includes a pulse oximetry function and a new Volume Support (VS) ventilation mode. It focuses on demonstrating substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it describes compliance with recognized standards and uses qualitative statements of "substantial equivalence" for the new features.

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or a number of test cases. The testing appears to be primarily bench testing (waveform performance, communication integrity) and compliance with standards rather than clinical trials with patient populations.
• Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing mentioned (waveform testing per ASTM F1100-90, software V&V) is likely performed in a lab or simulate environment. The country of origin of the device manufacturer is Switzerland.

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

• This information is not provided in the document. The document describes compliance with engineered performance standards and internal verification/validation, not the establishment of ground truth by human experts for a test set.

4. Adjudication Method for the Test Set:

• This information is not provided as the testing described does not involve expert adjudication of a test set in the way a clinical study or diagnostic imaging study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done. This document is for a medical device (ventilator) seeking 510(k) clearance, which typically relies on
  bench testing and substantial equivalence to predicates, not comparative effectiveness studies of human readers with vs. without AI assistance. The device itself is not an AI diagnostic tool.

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

• This question is not directly applicable in the context of this device. The HAMILTON-G5 is a ventilator, a physical device with embedded software and functions. The new features (VS mode, SpO2) are integrated functionalities of the device. The "standalone performance" of these functions (e.g., the SpO2 calculation itself) is established by using previously cleared OEM components and by verifying their integration into the HAMILTON-G5, not as a separate, algorithm-only performance assessment like that for a diagnostic AI.

7. The Type of Ground Truth Used:

• The "ground truth" for the new functionalities would be established by:
  • Engineering Specifications / Reference Devices: For the Volume Support mode, the "ground truth" for its performance is derived from the established performance characteristics and waveforms defined by the ASTM F1100-90 standard and comparison to the MAQUET Servo-i predicate device.
  • Calibration & Known Standards: For the SpO2 function, the "ground truth" for oxygen saturation and pulse rate values would come from the calibrated performance of the OEM pulse oximeter systems (Masimo, Nihon Kohden) and ensuring these values are accurately transmitted and displayed by the HAMILTON-G5.
  • Regulatory Standards: Overall safety and electromagnetic compatibility ("ground truth" for compliance) are established by fulfilling the requirements of the cited IEC standards.

8. The Sample Size for the Training Set:

• Not applicable. This document describes a medical device undergoing 510(k) clearance, not an AI or machine learning model that requires a "training set" in the conventional sense. The device's software (SW 2.30) is developed and verified through engineering processes, not by training on a dataset.

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

• Not applicable, as there is no "training set." The software development and verification process would involve testing against validated specifications and expected outputs based on engineering principles and regulatory standards.

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The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.

The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.

The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005). Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).

The provided text is a 510(k) summary for the Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station. The submission is for a software change to an existing predicate device, primarily allowing the central nurse station itself to perform alarm determination, which was previously handled exclusively by the telemetry receivers/transmitters.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, or alarm-related performance). Instead, it relies on substantial equivalence to a predicate device and general validation of software and hardware operation.

The "device performance" reported is largely that the device operates according to design specifications and that the non-clinical tests (electromagnetic, environmental, safety, and performance) verified proper operation.

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (e.g., patient data for arrhythmia detection). The studies mentioned are primarily non-clinical: electromagnetic, environmental, safety, and general performance testing, as well as design validation. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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. Since the submission focuses on a software change to an existing device and relies on non-clinical testing and substantial equivalence, there is no indication of expert-established ground truth for a clinical test set.

4. Adjudication method for the test set

This information is not provided. No clinical test set with human-adjudicated ground truth is described.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a central nurse station for physiological monitoring and alarm generation, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The document states that "Arrhythmia detection is a function of the telemetry receivers/transmitters" and "Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters." This implies that the device (or its components) performs alarm determination algorithmically and automatically. However, the exact performance metrics of this standalone algorithmic detection (e.g., sensitivity, specificity, positive predictive value for arrhythmia detection) are not provided in this summary. The summary focuses on the functionality of the alarm determination rather than its specific performance characteristics.

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

Given the nature of the device (physiological monitor and alarm system) and the type of information provided, the ground truth for "performance testing" and "design validation" would likely involve:

• Engineering specifications and test protocols: Verification that the device functions as designed against pre-defined engineering requirements (e.g., alarm triggers correctly at set limits, data display is accurate).
• Simulated physiological signals: For testing arrhythmia detection and alarm generation, simulated ECG signals with known arrhythmias would likely be used.

However, the document does not explicitly detail the type of ground truth used beyond "design specifications" and verification of "proper operation." There is no mention of ground truth established through expert consensus on clinical data, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. The document describes a software change to an existing device, not the development of a new algorithm that would typically involve a separate training set.

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

This information is not provided, as there is no mention of a training set.

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The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.

The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual beside monitor.

The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit.

This product will be available for use by medical personnel on all patient populations with a medical facility.

The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medial professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510K K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).

The new device receives a small subset (non-invasive telemetry parameters) all of the same information as the predicate device, i.e., receives physiological signal from telemetry transmitters/receivers from ORG 9700 Multiple Patient Receiver signal simultaneously, receives and displays physiological information. generates audible and/or visual alarm indictors when an alarm violation is detected by the telemetry units, stores waveforms for review and printing as full disclosure, stores tabular and graphical trending data for review and printing, provides network communications using commercially available LAN/WAN products, provides remote data access through NetProse access software and records and prints physiological patient data.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study proving the device meets them, as requested in your prompt.

The document discusses the regulatory submission for the NIHON KOHDEN NKUS LAB PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION, focusing on its substantial equivalence to a predicate device. It briefly mentions "design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications" and that the device "was subjected to electromagnetic, environmental, safety and performance testing procedures." However, it does not provide details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone performance study was done.
• The type of ground truth used for any evaluations.
• Sample size for training sets or how ground truth was established for them.

The device's description clarifies that "Arrhythmia detection and alarm determination are functions of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510K K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005)." This indicates that the core arrhythmia detection logic resides in separate, previously cleared devices, and the Central Nurse Station primarily displays and records data from these units.

Therefore, I cannot fulfill your request for details on acceptance criteria and study proving their achievement from the provided text.

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