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Use of the DS-5700 is indicated in those situations where centrally located hemodynamic monitoring of one or more patient's cardiovascular condition is desired and those patients are currently monitored at bedside by a Fukuda Denshi DS-5000 series bedside monitor. Use of this device is indicated only in a medically supervised healthcare environment. It is not for home use.

Device Description

The DS-5700 is a microprocessor based software controlled device. The system consist of a central station includes a freestanding 18 inch color LCD display. Up to 16 patients can be centrally monitored simultaneously from the ICU,CCU or other areas of the hospital. Input signals are provided by Fukuda Denshi series patient monitoring equipment that have been submitted under separate 510(k) filings, The DS-5700 is a true central station. All data is provided by external sources, Fukuda Denshi 5000 series patient monitoring equipment, for presentation and printout at central. The DS-5700 will act as a remote keypad for the bedside monitors, utilizing the touch screen capability of the LCD display, mouse or optional keyboard. The central station will act as a LAN administrator for monitors connected to the Fukuda Denshi patient monitoring LAN and display data from any sixteen of up to 64 bedside monitors. The DS-5700 will present alarm information, ECG analysis and any other hemodynamic data acquired and processed by the bedside monitors.

AI/ML Overview

The Fukuda Denshi DYNASCOPE DS-5700 is a central station monitor intended for the evaluation of the cardiovascular system. It receives data from Fukuda Denshi DS-5000 series bedside patient monitors via an Ethernet LAN and presents it for display and/or printout. The device is intended for use in hospital environments to monitor up to 16 patients simultaneously.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Design Specifications	Overall Design Specifications: The device must meet all design specifications.	"Laboratory testing was conducted to validate and verify that Fukuda Denshi Dynascope model DS-5700 Central Station Monitor meet all design specifications..." The conclusion states: "...this device is as safe, as effective and performs as well or better than the legally marketed predicate device..."
Environmental Testing	All environmental testing identified in the FDA's DCRND November 1993 "Reviewers Guidance Document for Premarket Notification Submissions."	Testing "consisted of all environmental testing identified in the FDA's DCRND November 1993 'Reviewers Guidance Document for Premarket Notification Submissions'."
Electrical Safety	Safe Current Limits: Adherence to "Safe current limits for electromechanical devices" and ANSI/AAMI EC13 Cardiac monitors, health rate meters and alarms.
Electrical Shock Risk: Mitigation of electrical shock to the user, including excessive electrical chassis leakage current.
Standards Compliance: Designed to meet UL 2601, CSA 22.2, and AAMI standards for electrical safety for medical equipment.	The device "demonstrated that it was in compliance with these standards and that it meet it device specifications."
Accuracy/Misdiagnosis	Data Acquisition, Display, and Printer Output: Adequate design to prevent inaccurate diagnostic data.
Software Design: Adequate software design to prevent inaccurate diagnostic data.
The device aims to provide accurate diagnostic information, as misdiagnosis is identified as a risk if data acquisition, display, printer output, or software design is inadequate.	"The design of the DS-5700 has taken into account all the above risk [including misdiagnosis due to inadequate design of data acquisition, display, printer output, and software]." The device is deemed "as safe, as effective and performs as well or better than the legally marketed predicate device..."
Overall Operation	System hazard analysis and validation of the system's overall operation.	"...a hazard analysis of the system and software was performed and testing was conducted to validate the systems overall operation."
Substantial Equivalence	The device must be "as safe, as effective and performs as well or better than the legally marketed predicate device, Fukuda Denshi model DS-5800 NXMB, K000746." This implies that it meets or exceeds the performance standards of the predicate device across all relevant safety and effectiveness metrics.	"The conclusions drawn from the laboratory testing the Fukuda Denshi model DS-5700 Central Station Monitor demonstrates that this device is as safe, as effective and performs as well or better than the legally marketed predicate device, Fukuda Denshi model DS-5800 NXMB, K000746."

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the test set.
- Data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The testing is referred to as "Laboratory testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is hardware and software validation against specifications and safety standards, not a clinical trial with expert-established ground truth.
Adjudication method for the test set:
- This information is not applicable/not provided. The testing described is primarily technical validation and verification, not diagnostic performance evaluation requiring adjudication of interpretations.
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, an MRMC comparative effectiveness study was not done. The device (Fukuda Denshi DYNASCOPE DS-5700) is a central station monitor, not an AI-assisted diagnostic tool for human readers. It collects and displays data from bedside monitors.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone testing was done. The "Laboratory testing" described involves validating and verifying that the device (system and software) meets design specifications and safety standards, and validating its overall operation. This would involve evaluating the algorithm's performance in processing and displaying data independently. The document states a "hazard analysis of the system and software was performed and testing was conducted to validate the systems overall operation."
The type of ground truth used:
- The ground truth in this context is defined by design specifications, industry standards (UL 2601, CSA 22.2, AAMI, ANSI/AAMI EC13), and FDA guidance documents (FDA's DCRND November 1993 "Reviewers Guidance Document for Premarket Notification Submissions," "Safe current limits for electromechanical devices"). The device was tested to ensure compliance with these established technical and safety benchmarks. The predicate device's performance also serves as a benchmark for "substantial equivalence."
The sample size for the training set:
- This information is not provided and is likely not applicable. The device is a monitor, not a machine learning model that requires a training set in the conventional sense. Its "intelligence" is based on microprocessors and software controlling data display and alarm functions, not adaptive learning from data.
How the ground truth for the training set was established:
- This information is not provided and is not applicable, as there is no mention of a training set for a machine learning model.

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