Search Results

The Nihon Kohden Vital Sign Telemeter GZ-140P is 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. GZ-140P transmits electrocardiogram (ECG), respiration data, blood oxygen saturation (SpO2) and non-invasive blood pressure (NIBP). 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 device can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screen and generate alarms without transmitting the data to other Nihon Kohden monitor.

The device is intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups, with the exception of NIBP measurement which is not intended for use on neonates.

The Nihon Kohden Vital Sign Telemeter GZ-140P is mainly used as a telemetry system within a medical facility. The device transmits patient's vital signs (ECG, SpO2, respiration, and blood pressure) 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 and used as a temporary simple monitor.

The provided text describes the Nihon Kohden Vital Sign Telemeter GZ-140P and its substantial equivalence to predicate devices, but it does not contain the specific details required to complete all sections of your request related to acceptance criteria, device performance, and study methodology for an AI/algorithm-based device in the way you've outlined.

The document discusses the device's function (monitoring and transmitting physiological data), its indications for use, and a comparison of its technological characteristics to predicate devices. It mentions that the atrial fibrillation detection algorithm is the same as a previously cleared device (QP-039P, K152305) and that the iNIBP (Inflation Mode) measurement was "validated in the clinical testing (Attachment 015)". However, Attachment 015 and its contents are not provided in this text.

Therefore, I cannot extract specific quantitative acceptance criteria or detailed study results (like sample sizes, expert qualifications, or MRMC study details) for the GZ-140P's arrhythmia detection or NIBP measurement from the provided FDA 510(k) summary letter.

Here's what I can extract and what is missing based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a readily extractable table format for features like arrhythmia detection accuracy or NIBP measurement precision for the GZ-140P itself. It relies on substantial equivalence and reference to previously cleared algorithms/devices.

What is mentioned:

• Atrial Fibrillation Detection Algorithm: "is exactly same as that of Nihon Kohden Afib Detection Program QP-039P (K152305)." This implies that the performance of K152305 serves as the reference.
• iNIBP (Inflation Mode) Measurement: "was validated in the clinical testing (Attachment 015)." The details of this validation, including performance metrics and acceptance criteria, are contained within Attachment 015, which is not provided.

Study Details (Based on available information and inferences)

As the document is a 510(k) summary, it focuses on substantial equivalence rather than a full clinical study report for this specific device's de novo performance. The details you've requested are typically found in the full submission or predicate device's documentation.

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

   • Test Set Sample Size: Not specified for the GZ-140P directly. The iNIBP validation was done via "clinical testing (Attachment 015)," but sample size is not stated here.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical testing implies prospective collection for that specific validation, but full details are missing.

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

   • Not specified in this document. This would be part of the "clinical testing (Attachment 015)" or the study for K152305.

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

   • Not specified in this document.

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:

   • Not indicated. This device is primarily a physiological data acquisition and transmission system with integrated algorithms (like AFib detection). The text does not describe an AI assistance role for human readers or an MRMC study. The AFib detection is a standalone algorithm.

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

   • Yes, implicitly for the AFib detection algorithm. The document states, "The atrial fibrillation detection algorithm is exactly same as that of Nihon Kohden Afib Detection Program QP-039P (K152305)." This implies that the standalone performance of QP-039P was already established and used as justification.
   • Not explicitly detailed for NIBP or other measurements beyond mentioning "clinical testing."

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

   • Not specified in this document. For physiological measurements like NIBP, ground truth is typically established by reference measurement devices or highly trained clinicians following specific protocols. For arrhythmia detection, it's typically expert-adjudicated ECG tracings.

7. The sample size for the training set:

   • Not specified. Given that the AFib algorithm is a previously cleared one (K152305), its training would have predated this submission. No information on training data for the GZ-140P itself is provided.

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

   • Not specified. This pertains to the development of the QP-039P algorithm or other internal algorithms; details are not in this summary.

In summary, this 510(k) summary relies on demonstrating substantial equivalence to predicate devices and previously cleared algorithms rather than presenting a de novo, detailed performance study for the GZ-140P's integrated functions. The key details about quantitative performance and study methodologies (especially for the atrial fibrillation detection and iNIBP validation) are either assumed based on prior clearances or are contained in referenced attachments not included here.

Ask a specific question about this device

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.

Ask a specific question about this device