(207 days)
Use of the DS-5800N is indicated in those situations where centrally located secondary hemodynamic monitoring is desired of patients that are currently primarily monitored at bedside by a Fukuda Denshi DS-5000 series bedside monitor. The DS-5800N is indicated where information from the DS-5000 series bedside monitor would include any or all of the following parameters: ECG, respiration, invasive and/or non-invasive blood pressures, temperature, pulse oximetry or cardiac output. Use of this device is indicated only in a medically supervised healthcare environment. It is not intended for home use.
The DS-5800N is a microprocessor based software controlled device. This central station monitor incorporates a 15 inch color CRT display. Up to eight patients can be centrally monitored simultaneously from the ICU, CCU, or other areas of the hospital. Input signals are provided by Fukuda Denshi 5000 series patient monitoring equipment that have been submitted under separate 510(k) filings. The DS-5800N is a true central station. All data is provided bv external sources. Fukuda Denshi 5000 series patient monitoring equipment, for presentation and printout at central. The DS-5800N will act as a remote keypad for the bedside monitors, utilizing its built in touch screen or optional keyboard. The central station will act as the LAN administrator for monitors connected to the Fukuda Denshi patient monitoring LAN and display data from any eight of up to 48 bedside monitors. The DS-5800N will present alarm information, ECG analysis, and other hemodynamic data acquired and processed by bedside monitors. The DS-5800N does not perform any of these functions. The DS-5800N is used to announce and control arrhythmia alarm information from the bedside.
This document describes the Fukuda Denshi Model DS-5800N Central Station Monitor, a device intended for hospital environments to centrally monitor up to eight patients simultaneously.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing quantitative acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) and corresponding reported performance metrics for the DS-5800N device's functionality as a central station monitor.
Instead, the acceptance criteria are implicitly defined by compliance with established safety standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Safety | - Electrical Safety: Compliance with UL 601, CSA 22.2, and AAMI standards for electrical safety for medical equipment. Prevention of excessive electrical chassis leakage current to prevent arrhythmias. | - "The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment." |
- "The device has been tested demonstrate compliance with these standards and to verify that the device does meet all specifications." |
| Effectiveness/Functionality | - Substantial Equivalence: Performance and safety are "as well as or better than" the predicate device (FUKUDA DENSHI model DS-3300, K894628). - Design Specifications: Meet all design specifications.
- System Validation: Overall system validation confirmed through testing in a simulated environment. | - "The conclusions drawn from the laboratory testing... demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device."
- "Laboratory testing was conducted to validate and verify... met all design specifications." |
| Software Integrity | - Hazard Analysis: Software hazard analysis conducted. - Validation: System validation performed. Adherence to software development process and quality assurance procedures. Functional requirements met and system specifications fulfilled. | - "Addressing safety issues... addressed... in the systems hazard analysis and in the system validation."
- "I hereby certify that the attached software development process and quality assurance procedures were adhered to and that all testing performed demonstrates that the functional requirements were met and that the system specifications were fulfilled." |
| Environmental | - Environmental Testing: All environmental testing identified in FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. | - "This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 'Reviewer Guidance Document for Premarket notification Submissions' Draft Guidance Document." |
| Data Integrity | - Prevention of Misdiagnosis: Adequate design of data acquisition, display, and printer output circuitry/program to prevent inaccurate diagnostic data. Adequate software design to prevent inaccurate diagnostic data. | - "The design of the DS-5800N has taken into account all the above [risks, including misdiagnosis]." (This is a design claim, not a measurement of performance). |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that "Laboratory testing was conducted to validate and verify the FUKUDA DENSHI DynaScope model DS-5800N Central Station Monitor met all design specifications". However, it does not specify a "test set" in terms of patient data or clinical cases for evaluating performance metrics. The testing described focuses on compliance with standards and equivalence to the predicate device in a simulated environment.
Therefore:
- Sample size for the test set: Not specified in terms of patient data or case numbers. The testing appears to be a systems-level and compliance-based evaluation rather than a clinical performance study on a particular dataset.
- Data provenance: Not applicable, as the document does not describe the use of specific clinical data (retrospective or prospective, country of origin) for performance evaluation. The testing was described as "laboratory testing" and testing "in a simulated environment."
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. The study is described as "laboratory testing" and "testing in a simulated environment" for compliance with engineering and safety standards, and for functional equivalence. It does not involve establishing ground truth from clinical experts for diagnostic accuracy, as the device primarily presents data acquired and processed by bedside monitors.
4. Adjudication Method for the Test Set
This information is not provided and is likely not applicable given the nature of the described testing (laboratory, simulated environment, compliance with standards, functional equivalence).
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a Central Station Monitor, which primarily displays and manages data from other patient monitors. It does not perform "AI" or diagnostic functions that would involve human readers interpreting output for improved performance. The device itself "does not perform any of these functions [alarm information, ECG analysis, and other hemodynamic data acquired and processed by bedside monitors]."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself is a "microprocessor based software controlled device" that acts as a central station to display data from other monitors. It's not an algorithm that performs standalone analysis or diagnosis. Its performance is evaluated fundamentally as a system displaying and transmitting data, and being safe, rather than a diagnostic algorithm. Therefore, a standalone algorithmic performance study in the typical sense was not performed, as the device's primary function is aggregation and display, not independent diagnostic computation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of clinical ground truth (expert consensus, pathology, outcomes data) for the evaluation of the DS-5800N. The testing focused on:
- Compliance with electrical safety and environmental standards.
- Verification that the device "met all design specifications."
- Substantial equivalence to the predicate device's central station function.
- Validation of software functionality and adherence to development procedures.
The "ground truth" implicitly refers to the correct functioning of the system according to its design specifications and regulatory standards, rather than diagnostic accuracy against a clinical gold standard.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset in the modern sense. It is a software-controlled electronic device for data display and management.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.