Search Results

The Fukuda Denshi model DS-5300 Patient Monitor provides a simple and reliable method to display and document the continuos hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients: neonate, pediatric, and adult; mav be located in a hospital ICU, CCU, OR, ER, recovery, or other critical care unit. The DS-5300 can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician. Parameters such as ECG, respiration, noninvasive or invasive blood pressures, temperature, pulse oximetry, and cardiac output may be monitored individually or in any grouping required by the clinician. This device is not intended for home use.

The DS-5300 Patient Monitor System is meant to acquire and monitor physiological signals from patients located within a healthcare facility. The system is designed to be used in an ICU, CCU. OR, ER, or Recovery areas of a hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric, and trend data from these patients are available to the clinician on the system's display or it may be printed on the system's recorder. The basic system consists of the main control unit, the display unit and the input box connected to the main unit via fiber optic cable to reduce electrical artifact and noise. The main body of the system can be remotely located from the display unit and input box for increased flexibility. Small, lightweight, but powerful in its application of technology, the DS-5300 patient monitoring system is flexible and easy to use. Incorporation of high speed RISC (reduced instruction set computing) microprocessors, a 9.4 inch TFT color LCD display and a high quality, analog touch screen has made the DS-5300 a unique and versatile patient monitor. The die cast aluminum body eliminates the need for a cooling fan and provides a light, strong body. Use of low power, high speed, flash memory allows for easy upgradeability through a standard PCMCIA compatible IC card. Physiological parameters are monitored through the use of flexible parameter modules that are easily inserted or removed from the input box.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Fukuda Denshi model DS-3300 Patient Monitor) rather than providing extensive details about specific acceptance criteria and detailed study results for each function. Therefore, some of the requested information cannot be fully extracted.

Here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for all functions. Instead, it states that the device was tested to meet various design specifications and standards. For certain modules (NIBP, Pulse Oximetry, Arrhythmia/ST Level), it mentions that the results are presented in tabular and graphic format in an unprovided appendix.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size:
  • For NIBP, Pulse Oximetry, and Arrhythmia/ST Level sections, the document states "The results of this testing is presented in tabular and graphic format in the appendix" or "in tabular format in the appendix," but the specific sample sizes (number of patients, number of measurements, etc.) are not provided in the excerpt.
  • No information on test set sample sizes for other tests like electrical safety or environmental testing.
• Data Provenance: Not specified in the provided text. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not specified. The document mentions testing against standards and protocols (e.g., AAMI, Nellcor protocols), but it does not describe the involvement of human experts in establishing a ground truth for testing the device's diagnostic performance.

4. Adjudication Method for the Test Set:

• Not specified. Given the lack of information on expert-established ground truth, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The provided text does not describe an MRMC study comparing human readers with and without AI assistance. The testing described is primarily for device performance against established standards and safety requirements. The device is a "Patient Monitor," and its algorithms are based on "Fukuda Denshi algorithms that have been in use and are part of the standard Fukuda Denshi software library," suggesting existing, validated algorithms rather than a novel AI system requiring human-AI comparative studies for this submission.

6. Standalone Performance Study:

• Yes, implicitly. The various performance tests (NIBP, Pulse Oximetry, Arrhythmia/ST Level) conducted according to recognized standards (ANSI/AAMI, Nellcor protocols) are evaluating the algorithm's performance in a standalone capacity (i.e., the algorithm's output is being compared to the output dictated by the standard or protocol, not against a human's interpretation of data from the device). The device is a patient monitor, designed to "display and document" physiological observations, so its primary function is standalone measurement and display.

7. Type of Ground Truth Used:

• Expert Consensus/Standard Reference: For NIBP, Pulse Oximetry, and Arrhythmia/ST Level, the ground truth is implicitly defined by the referenced industry standards and testing protocols (e.g., ANSI/AAMI SP10 for NIBP, Nellcor's protocol for pulse oximetry, AAMI ECAR-1987 for arrhythmia). These standards typically define methods for generating known, accurate physiological signals or for comparing device measurements against highly accurate reference devices (which could be considered a form of "expert consensus" in their development and validation).
• Design Specifications & Safety Standards: Many of the other tests (environmental, electrical safety) use compliance with established safety and performance standards as their ground truth.

8. Sample Size for the Training Set:

• Not provided. The document states that the algorithms are "based on Fukuda Denshi algorithms that have been in use and are part of the standard Fukuda Denshi software library." This suggests the algorithms were developed and potentially trained (if applicable to the algorithm type) prior to this specific device, but no details about any training sets are given. Given the 1996 date, "AI" as we understand it now was not prevalent, and "algorithms" likely refer to more traditional signal processing and detection methods.

9. How the Ground Truth for the Training Set Was Established:

• Not provided. As the training set details are absent, the method for establishing its ground truth is also not mentioned.

Ask a specific question about this device