Search Results

Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the 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 systems display or may be printed on the system's recorder.

The DS-8100N/8100M provides monitoring of ECG (Up to 7lead), heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, and parameters in combination of invasive blood pressure (IBP) (max. 2ch.), temperature (max. 4ch.), and cardiac output (max. 1ch.) using the multiparameter connector. In addition, the DS-8100M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The DS-8100N for SpO2 measurement utilizes a technology of an OxiMax N-600x Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K060576. The DS-8100M for SpO2, SpCO, SpMet, and SpHb measurement utilizes a technology of a Masimo RADICAL 7 Pulse CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K110028. All parameter connectors are on the front panel and are labeled on the left side of the main unit. By connecting the optional CO2 Gas Unit (HCP-800/HCP-810) or Gas Unit I/F (HPD-800/HPD-810) to the AUX Connector on the rear side of the main unit, it provides monitoring of carbon dioxide concentration (CO2) The CO2 Gas Unit (HCP-800/HCP-810) that utilizes Oridion Medical 1987 Ltd. technology "Microstream"" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800/HPD-810) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the main unit with serial communication protocol for CO2 monitoring.

The DS-8100N/8100M is a self-contained monitor, which includes a 10.2 inch TFT color LCD display which can display up to 14 waveforms and up to 14 numeric displays. The user interfaces, the touch screen panel, is located on the front of the main unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the main unit. The infrared remote-control command is also available (optional). By attaching the optional Recorder Unit (HR-800) or Recorder/Expansion Port Unit (HR-811), a dot matrix thermal printer, on the bottom of rear of the main unit, it provides hard copy recordings of all monitored parameters and can print up to three (3) waveforms simultaneously. In addition, the Recorder/Expansion Port Unit (HR-811) contains the Analog Output Connector that outputs the ECG and BP waveforms, including the ORS SYNC output signal, VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor. By attaching the Expansion Port Unit (CU-810) on the bottom of rear of the main unit, it provides the VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor or connects to the laser printer as general LAN.

Additional standard features include DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (#K970585), through a built in Ethernet LAN, and a wireless connection using the optional telemetry transmitting module (Model: HLX-801) and a wireless bidirectional communication using the optional Bidirectional Wireless Communication Module (Model: HTC-702) allow remote monitoring when combined with Fukuda Denshi Central Station Monitors. An option battery operation allows a patient to continue to be monitored during intra-hospital transport.

The DS-8100N/8100M is small and lightweight at 3.5 kg. The physical dimensions of the device are 300 mm (W) x 265 mm (H) x 75 mm (D).

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is a multi-parameter patient monitor. The provided document doesn't detail specific acceptance criteria and the associated study results for each parameter within the device. Instead, it offers a general statement that the device has undergone "extensive safety, environmental and performance testing" to ensure all functional and performance specifications are met. It also states that OEM engineering test facilities confirmed the performance and functional specifications for their supplied modules.

The conclusion asserts that the device is "as safe and effective and performs as well as the legally marketed predicate devices" based on "laboratory testing, validation, and risk analysis." This implies a comparative study against predicate devices and adherence to various safety and performance standards, rather than proving performance against predefined quantitative acceptance criteria with specific metrics.

Here's a breakdown of the available information based on your request, even though specific quantitative acceptance criteria are not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the provided text for each parameter (ECG, NIBP, SpO2, etc.), a table cannot be fully constructed with precise numbers. The document generally states that "all functional and performance specifications were met."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "various performance tests" and "OEM engineering test facility" testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily technical and performance-based against established standards and predicate device performance, not reliant on expert clinical interpretation for ground truth.

4. Adjudication Method

The document does not describe any adjudication method. This is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is a patient monitor, and its evaluation would generally focus on the accuracy of its physiological measurements against reference standards, rather than the improvement of human reader performance with AI assistance. The document focuses on performance specifications and equivalency to predicate devices.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was implicitly done for various parameters (e.g., SpO2, CO2, ECG performance) by testing against relevant standards (e.g., ANSI/AAMI EC13 for ECG, ISO 9919 for pulse oximeters). The document states: "Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications were met." This refers to the device's ability to accurately measure and display physiological data.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Reference standards/simulators: This is typical for physiological monitors, where the device's measurements are compared against highly accurate reference instruments or simulated physiological signals.
• Performance of predicate devices/OEM modules: The document explicitly states the device utilizes technologies "incorporated into previously cleared devices and OEM manufactured module" and that performance was confirmed by OEM test facilities. This implies comparison against the established performance of those components.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient monitor that measures physiological parameters, not an AI/ML device that requires a large dataset for training a diagnostic algorithm. The algorithms for signal processing and measurement in patient monitors are typically deterministic or based on established physiological models, not machine learning that would involve a "training set."

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as the device is not described as using machine learning that requires one), the document does not describe how ground truth for a training set was established.

Ask a specific question about this device

The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoqlobin (SpO2) and pulse rate. It is also indicated for continuous noninvasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.

Capnostream®20p is to be operated by qualified healthcare personnel only. The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20p HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The HiFi capnography software feature, presented in this submission, is intended to enable measurement of airway CO2 for infant/neonatal patients during high frequency oscillatory ventilation (HFOV) and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

Here's an analysis of the acceptance criteria and study information for the Capnostream® 20p with HiFi CO2 monitoring, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance for the Test Set

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was performed on a "lung simulator system."
• Data Provenance: The testing was conducted on a "lung simulator system," indicating it was not performed on human subjects. This suggests a controlled laboratory environment rather than retrospective or prospective clinical data from a specific country of origin.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Not applicable as the ground truth was established through a "lung simulator system" rather than expert interpretation of biological data. The "ground truth" would be the known, controlled CO2 and respiratory rate inputs of the simulator.

4. Adjudication Method for the Test Set

• Not applicable. Since the testing was done on a lung simulator, comparison would have been to the known, programmed values of the simulator, not requiring expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a measurement instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting output. The study focused on the accuracy of the device's measurements.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The performance testing on the lung simulator system assessed the algorithm's (Capnostream20p with HiFi) ability to accurately measure CO2 and detect breaths independently of human interpretation.

7. Type of Ground Truth Used (Test Set)

• The ground truth used was the known, controlled parameters established by the "lung simulator system." This would include the programmed CO2 concentrations and respiratory rates (both passive and spontaneous).

8. Sample Size for the Training Set

• The document does not explicitly state a training set sample size. Given the nature of a capnograph/pulse oximeter, its core algorithms are typically based on physiological models and physical principles (e.g., infrared absorption for CO2). While there might be internal tuning or calibration processes that could be considered "training" in a broad sense, it's not described as a machine learning model with a distinct training dataset in the same way as an image recognition AI. The focus is on the validation of the HiFi software feature.

9. How the Ground Truth for the Training Set was Established

• Not explicitly described in the document. As mentioned above, for this type of device, "training" might not involve a distinct ground truth dataset in the way a modern AI algorithm would. Its development would likely rely on physical laws, engineering specifications, and possibly internal testing to refine signal processing and detection algorithms within the device.

Ask a specific question about this device

The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

This is a 510(k) summary for Philips SureSigns VS3 and VS4 vital signs monitors, describing modifications to add additional measurement capabilities. The provided text, however, does not contain information about specific acceptance criteria or a detailed study proving the device meets said acceptance criteria with numerical performance data. It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

Therefore, I cannot fulfill all parts of your request with the provided information.

However, based on the information available, here's what can be extracted:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table or numerical format. The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence," implying that the devices met pre-defined specifications. However, the exact criteria and corresponding performance metrics are not detailed.

• Sample Size for Test Set and Data Provenance: This information is not explicitly stated in the provided text.

• Number of Experts and Qualifications: This information is not mentioned in the provided text.

• Adjudication Method: This information is not mentioned in the provided text.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was done. The device is a vital signs monitor, which typically involves direct measurement rather than interpretation by multiple human readers in the way an AI-assisted diagnostic tool might.

• Standalone (Algorithm Only) Performance Study: The document mentions that the new features are achieved by using OEM modules that are "FDA cleared under Kxxxxxx." This implies that the performance of these modules as standalone components was already established in their respective clearances. For instance, for CO2 measurement, the Oridion microMediCO2 OEM module was cleared under K094012; for SpHb, RRa, and Masimo SpO2, the Masimo Rainbow SET Radical 7R CO-Oximeter was cleared under K100428; and for Temporal Temperature, the Exergen TemporalScanner Thermometer was cleared under K011291. The QuickNBP mode is described as based on the "same algorithm that provides the regular NBP measurements" in the existing devices. Therefore, while not explicitly called a "standalone study," the reliance on previously cleared, established technologies suggests that their standalone performance has been demonstrated.

• Type of Ground Truth Used: Not explicitly stated for the overall device's performance. However, for the OEM modules incorporated, their original clearances would have involved appropriate ground truth methods for each physiological parameter (e.g., direct measurement for temperature, arterial blood gas analysis for SpO2 calibration, etc.).

• Sample Size for Training Set: This information is not applicable as the document describes hardware modifications incorporating existing, cleared OEM modules and leveraging existing algorithms. It does not mention the development or training of new algorithms that would require a distinct training set.

• How Ground Truth for Training Set Was Established: Not applicable given the nature of the device modifications.

In summary, the provided text primarily focuses on the substantial equivalence argument for modifications to existing vital signs monitors by integrating previously cleared OEM modules and leveraging existing algorithms. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, expert involvement, or adjudication methods that your request entails for a newly developed AI/diagnostic device.

Ask a specific question about this device