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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's cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi DS-5000 series 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

The DS-5000 Series Telemetry Monitoring System consists of the Fukuda Denshi model DS-5800N central monitor (K970585), the LW-5500N central telemetry receiver, the HLX-501 multiparameter transmitter, and the LX-5120 ECG/Respiration transmitter. The units are microprocessor based software controlled devices. The LW-5500N can receive data for 4 or 8 patients and can be connected to the DS-5800N central monitor either directly, or via local area network (LAN). The LAN communication specifications for the DS-5800N remain unchanged. Each patient whose data is received by the LW-5500N is considered as a separate network node. Input signals are provided from the HLX-501 multiparameter transmitter connected to a bedside monitor, or from the LX-5120 ECG/Respiration transmitter that is attached to the patient.

Patient physiological data displays, controls, recordings and alarms are controlled from the DS-5800N central monitor. Recording can also be initiated from the bedside monitor, or from the patient worn transmitter. System functions, such as trending, arrhythmia and ST monitoring, and data access are available to the user from the central monitor. No changes were made to the arrhythmia or ST measurement algorithms.

The addition of multiparameter telemetry with the HLX-501 is a new telemetry feature, providing up to six waveforms and numeric data from the bedside monitor to the central station, and is the most significant change.

The new system uses PLL synthesized tuning instead of crystal replacement to select a new telemetry channel. The new system incorporates digital FSK data transmission in the UHF band.

The provided text describes the Fukuda Denshi Model DS-5000 Series Telemetry Monitoring System, but it does not contain information related to acceptance criteria, device performance metrics, or a study that evaluates the device against such criteria.

The document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving the device meets them, as that information is not present in the provided text.

Based on the information provided, here's what can be extracted, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Not Available. The document does not define specific acceptance criteria (e.g., accuracy percentages, sensitivity, specificity for arrhythmia detection) nor does it report numerical device performance against such criteria. The testing section mentions compliance with safety and electrical standards but not functional performance metrics in the way you've described.

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

• Not Available. The document states "Laboratory testing was conducted to validate and verify the DS-5000 Series Telemetry Monitoring System and its components to meet all design specifications." However, it does not specify the sample size for any test set or the provenance of any data used for functional evaluation.

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

• Not Available. There is no mention of experts establishing ground truth for any test set, as a performance study of that nature is not detailed.

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

• Not Available. This information is not present.

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 Available. The device is a central telemetry monitoring system, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, an MRMC study or AI assistance efficacy is not applicable to this device as described.

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

• Partially Addressed, but not in the requested format. The document states, "No changes were made to the arrhythmia or ST measurement algorithms." This implies the arrhythmia and ST algorithms operate in a standalone manner within the device. However, it does not provide performance metrics from any standalone algorithm-only study. The "Testing" section focuses on safety, electrical standards, and system validation, not detailed algorithmic performance.

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

• Not Applicable/Not Available. Since no specific performance study with a test set and ground truth is described, this information is not provided. The testing mentioned is for compliance with regulatory and safety standards.

8. The sample size for the training set:

• Not Available. The document doesn't discuss a training set, as it describes a device using established algorithms rather than a newly developed machine learning model.

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

• Not Available. As there's no mention of a training set, this information is not provided.

Summary of available information related to "Testing":

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with established safety and electrical standards.

• Testing conducted: Laboratory testing to validate and verify the DS-5000 Series Telemetry Monitoring System and its components to meet all design specifications.
• Standards referenced:
  • FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket Notification submissions" Draft Guidance Document.
  • ANSI/AAMI ES1-1993, "Safe Current Limits for Electromedical Apparatus."
  • ANSI/AAMI EC13-1992, "Cardiac Monitors, Heart Rate Meters, and Alarms."
  • FCC certification for telemetry systems.
  • UL 2601-1, CSA 22.2, and AAMI standards for electrical safety.
• Other validations: Hazard analysis performed for system components and software, and testing conducted to validate the system's overall operation.
• Conclusion of testing: The test results confirm that the device is designed to meet the specified standards and objectives, demonstrating that it is safe and effective and performs as well as or better than the legally marketed predicate device(s).

In essence, the 510(k) summary provides evidence of compliance with regulatory and safety standards, and equivalence to existing devices, but not a detailed clinical performance study with acceptance criteria as you've requested.

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