(116 days)
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.
| Feature/Metric | Acceptance Criteria (Not explicitly stated for GZ-140P, relies on predicate) | Reported Device Performance (Not provided for GZ-140P, relies on predicate/unseen attachment) |
|---|---|---|
| Arrhythmia Detection (AFib) | Assumed to meet performance of Nihon Kohden Afib Detection Program QP-039P (K152305) | Not detailed in this document. |
| NIBP Measurement (iNIBP) | Assumed to meet performance validated in clinical testing (Attachment 015) and similar to Welch Allyn Spot Ultra Vital Signs (K040490) | Not detailed in this document. |
| Other physiological data (ECG, Respiration, SpO2) | Assumed to meet performance of Nihon Kohden BSM-6000 Series Bedside Monitor (K080342) and GZ-120P/GZ-130P (K153707) | Not detailed in this document. |
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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in this document.
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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.
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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."
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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.
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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.
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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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.