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The Fukuda Denshi DS-5000 series Telemetry Monitoring System is indicated in those situations where centrally located hemodynamic monitoring (central station monitoring) of one or more patients cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g. ER, ICU or clinic). It is not intended for home use. This device is intended for Prescription Use Only

The Fukuda Denshi model DS-5000 series Telemetry Monitoring System consists of a series of interface devices which include a central transmitter receiver, an HLX-501 Multi-parameter transmitter, LX-5120 patient worn ECG/Respiration transmitters, and a Fukuda Denshi DS-5000 series Central Patient Monitor (K970585, K000746, K020084). The unit's are processor based software control devices. The receiver module can receive data for 4 or 8 patients and can be connected either directly or by local area network (LAN) to the DS-5000 series Central Patient Monitor. Each patient data when received at the central transmitter receiver is considered as a separate network node. Input signals are provided from the patient worn LX series transmitters or from the HLX-501 Multi-parameter transmitter when connected to a Fukuda Denshi DS-5000 series patient monitor.

Patient physiological data displays, controls, recordings and alarms are controlled from the Central Patient Monitor. Recordings can also be initiated from the bedside monitor or from the patient worn transmitters. System functions such as trending, arrhythmia and ST monitoring and data access are available to the user from the central monitor.

The HLX-501 multi-parameter transmitter may provide up to six waveforms and numeric data from the bedside monitor. Parameter monitored may include ECG, SpO2, Resp, BP, NIBP and Temp.

The patient worn LX-5120 transmitter provides monitoring of ECG and Respiration parameters.

The modified transmitter subject to this submission, the patient worn LX-5630 provides ECG and Respiration monitoring identically as the LX-5120 and adds SpO2 transmission through the integration of an Pulse Oximetry OEM module designed and manufactured by Konica Minolta Sensing Inc and cleared as the Minolta Pulseox-3 LI (K010413).

Acceptance Criteria and Device Performance:

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific sample size (number of patients or data points) for the "Verification and validation testing." The testing involved safety testing (electrical safety, EMC, radio telemetry) and pulse oximetry laboratory accuracy testing. The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. The testing aimed to confirm compliance with existing standards and predicate device performance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation. The testing focuses on technical performance and compliance with specifications and predicate device performance.

3. Adjudication Method for the Test Set:
Not applicable. The description does not involve a diagnostic interpretation or a need for adjudication among multiple reviewers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study focused on technical validation and comparison to a predicate device's established performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the testing described appears to be for standalone performance. The "Verification and validation testing" assessed the device's technical specifications, safety, and accuracy in transmitting and monitoring physiological data, and the accuracy of the integrated pulse oximeter module. This falls under the realm of evaluating the algorithm's and hardware's inherent performance.

6. Type of Ground Truth Used:
The ground truth for the technical and safety testing appears to be based on:
* Established specifications: Compliance with electrical safety, EMC, and radio telemetry standards.
* Predicate device performance data: Specifically, for pulse oximetry accuracy, the reference was the clinical testing results submitted with the Minolta PULSOX-3Li oximeter (K010413), which was a legally marketed and cleared OEM module.

7. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI. This device is described as a telemetry monitoring system with integrated hardware modules, not a machine learning-based diagnostic tool that would require a separate training dataset.

8. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning model is mentioned or implied for this device.

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