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The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic. cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment, arrhythmia analysis, and SpHb for which the target populations are adult and pediatric only excluding neonates. The DS-8000 Series monitor can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients mav be in a clinic or other healthcare environment under the care of a physician.

The availability of DS-LAN connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with Fukuda Denshi Central Station Monitors.

Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N>O), oxygen concentration (0>), anesthetic agent concentration (AG), and Spirometry may be monitored individually or in any grouping required by the clinician.

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.

The Fukuda Denshi DynaScope Model DS-8000 Series 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 model DS-8500 is a modular monitor. The system consists of the main control unit (model: DSC-8510/DSC-8530), the display unit (model: LC-8019T/LC-8019TC/LC-8015T/LC-8015TC), the Super Unit (model: HS-8312N/HS-8312M), the HS Adapter (model: HSA-80) for the Super Unit attachment, the Input Box (model: IB-8004), the Expansion Modules (model: HM-800/HG-810/HG-820/HP-800) that plug into the input box, the Expansion Units (model:MGU-801P/MGU-802/ MGU-803/MGU-811P/MGU-812/MGU-813/HR-800), CO2 Gas Unit (model: HCP-800), and Gas Unit I/F (model: HPD-800). The main body of the system in designed so it can be remotely located from the display unit, the Super Unit, the Recorder Unit, and the Input Box.

There are two (2) types of the main units depending on the built-in display board configuration as follows.

• External Monitor Output (1ch) DSC-8510:
• External Monitor Output (1ch), Extended Display Monitor Output (2ch), DSC-8530: LAN (TCP/IP) IF (1ch)

There are four (4) types of the display units depending on the display size and filter as follows.

LC-8019T: 19 inches LC-8019TC: 19 inches with Circular Polarizing Filter LC-8015T: 15 inches LC-8015TC: 15 inches with Circular Polarizing Filter

The display unit contains a 15/19 inches diagonal, active matrix TFT color display and a clear touch screen. The 15/19"display is capable of presenting up to 20/28 waveforms.

The user interfaces, the touch screen panel, is located on the front of the display 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 display unit. The infrared remote-control command is also available (optional). The right side of the display unit contains two (2) Mouse/Keyboard Connection Connectors (PS/2 port).

The model DS-8200 is a modular monitor. The system consists of the Display Unit (model: LC-8210), the HS Adapter (model: HSB-80), the Base Unit (model: BS-8210), the Super Unit (model: HS-8312N/HS-8312M), CO2 Gas Unit (model: HCP-800), Gas Unit I/F (model: HPD-800), and the Recorder Unit (model: HR-800).

The Display Unit (LC-8210) contains a 10.2 inches diagonal, active matrix TFT color display and a clear touch screen. The 10.2"display is capable of presenting up to 14 waveforms. It also contains the Standby Switch, the Power Supply Indicator, and the Battery Charge LED on the bottom left of the front side, an alarm indicator, which alerts to alarm conditions, on the top, Telemeter Module (HLX) Insertion Slot (with the cover), one (1) CF Card Slot, one (1) CF Card Access Indicator, one (1) SD Card Slot, and one (1) SD Card Access Indicator on the right side, one (1) Display Unit Extension Cable Connector on the left side, and interface connector to the HS Adapter (HSB-80) on the rear side.

The HS Adapter (HSB-80) contains one (1) Display Unit Connector, the Display Unit Extension Cable Connector, the Operation Mode Change Switch (reserved), and the Battery Charge LED on the front side, one (1) module-LAN Connector on the right side, and the Super Unit Connector and the Battery Insertion Slot (with the cover) on the left side.

The Base Unit (BS-8210) contains the Power Supply Indicator, the Battery Charge LED, the Battery Insertion Slot (with the cover), and one (1) Serial Connector (COM1) on the front side, the AC Mains Input Connector, one (1) Serial Connector (COM2), one (1) External Monitor Connector, two (2) Status Input/Output Connectors, and one (1) DS-LAN Connector on the rear side, one (1) U-LINK Connector on the left side, and the HS Adapter Connector on the top.

The user interfaces, the touch screen panel, is located on the front of the display 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. The infrared remote-control command is also available (optional). An option battery, which is built in to the Base Unit (BS-8210) and/or HS Adapter (HSB-80), operation allows a patient to continue to be monitored during intra-hospital transport.

The HS-8312N/HS-8312M Super Unit provides monitoring of ECG (Up to 12lead), heart rate, respiration (RESP), non-invasive blood pressure (NIBP), pulse rate (PR), arterial oxygen saturation (SpO>), plethysmograph, and up to six (6) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using three (3) multiparameter connectors. In addition, the HS-8312M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The NIBP measurement for the HS-8312N/M utilizes the NIBP module that is the exact same technology and algorithm as approved in the Fukuda Denshi Model DS-7000 Series Patient Monitor and provides the 510(k) #K083697. And the 12-Lead ECG monitoring provides the 12-Lead ECG analysis function using the 12-Lead ECG analysis software module that is the same as that used in the Fukuda Denshi CardioMax model FX-4010 Multi Channel Electrocardiograph, 510(k) #K981066. The HS-8312N for SpO2 measurement utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) #K021090. The HS-8312M for SpO2, SpCO. SpMet, and SpHb measurement utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The NIBP Start /Stop Key with indicator, which lights during NIBP measuring, BP Zero Balance Key with indicator, which lights during BP zero balancing, Alarm Silence Key with indicator, which lights during the alarm silence condition, and Power Supply Indicator are located on the top of the front panel. And all parameter connectors are on the front panel and are labeled. The left side of the unit contains the Analog Output Connector that outputs the ECG and BP waveforms, including the QRS SYNC output signal. To connect the Super Unit to the Main Unit, the HSA-80 HS Adapter (for DS-8500)/HSB-80 HS Adapter (for DS-8200) is required.

The HCP-800 CO2 Gas Unit or HPD-800 Gas Unit I/F provides monitoring of carbon dioxide concentration (CO2) by connecting to the AUX Connector on the front of the Super Unit. The CO2 Gas Unit (HCP-800) that utilizes Oridion Medical 1987 Ltd. technology "Microstream" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the Super Unit with serial communication protocol for CO2 monitoring.

The HM-800 Multi Module provides monitoring of up to four (4) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using two (2) multiparameter connectors, which are on the front panel and are labeled. The Power Supply Indicator and BP Zero Balance Key with indicator, which lights during BP zero balancing, are located on the top of the front panel.

The HG-810/MG-820 SpO2 Module provides monitoring of arterial oxygen saturation (SpO2), plethysmograph, and pulse rate (PR). The HG-810 also provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The MG-810 utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The HG-820 utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K021090. And the SpO2 connector is on the front panel and is labeled and the Power Supply Indicator is located on the top of the front panel. In addition, in conjunction with the Super Unit. it provides monitoring of two (2) different sites of arterial oxygen saturation (SpO2). In case of HG-810 in conjunction with the HS-8312M, the monitoring of two (2) different sites of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb) is also available.

The HP-800 Multiport Module contains two (2) Status Input/Output Connectors for serial communications with the external device and one (1) Analog Input Connector, which 2 channels of inputs are available, to input analog signal from the external device. All connectors related to connection with the external devices are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel.

The IB-8004 Input Box provides the expansion monitoring by plugging the Expansion Modules, such as HM-800, HG-810/MG-820, and HP-800, into. There are four (4) slots for Expansion Module plug-in. Within one (1) DS-8500 system, the connectable number of Input Box is up to two (2), so the plugging of up to eight (8) Expansion Modules is available.

The MGU-800 series (MGU-801P/MGU-802/MGU-803)/ 810 series (MGU-811P/MGU-812/MGU-813) Multigas Unit provides monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG). It utilizes a technology of the sidestream multigas analyzer manufactured by ARTEMA Medical AB. and previously cleared under 510(k) # K053234 by Mindray. Depending on the following model type of the Multigas Unit, the measurable gas parameters are as follows.

MGU-801P/MGU-811P: CO2, N2O, O2, and AG
MGU-802/MGU-812: CO2, N2O, and AG
MGU-803/MGU-813: CO2, and N2O

In addition, the MGU-810 series (MGU-811P/MGU-812/MGU-813) provides monitoring of spirometry that utilizes the respiratory mechanics analyzer and flow sensor, manufactured by ARTEMA Medical AB, which is similar to a technology previously cleared under 510(k) # K062754 by Datascope. All connectors related to measurement are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel.

The HR-800 Recorder Unit, a dot matrix thermal printer, provides hard copy recording s of all monitored parameters and can print up to three (3) waveforms simultaneously. On the top of the front panel, the Power Supply Indicator, Print Key with indicator, which lights during printing, and Paper Feed Key with indicator, which lights during paper feeding, are located. The Open/Close Lever to open/close the paper holder is located on the right upper part of the front of the unit.

Additional standard features include the DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors.

The provided text is a 510(k) premarket notification for a patient monitor and does not contain the detailed clinical study information typically found for devices with specific performance claims related to diagnostic accuracy (like computer-aided detection/diagnosis systems).

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is a physiological monitoring device that measures various parameters. The 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of conducting new clinical trials to prove efficacy, the manufacturer demonstrates that their device is as safe and effective as devices already on the market, usually by showing it has the same technological characteristics and meets established performance standards.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert ground truth, and comparative effectiveness studies are not explicitly present in this document because the device's approval hinges on demonstrating equivalence through testing to standards and internal verification rather than de novo clinical performance studies for AI algorithms.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria or quantitative performance metrics in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it states that the device was subjected to "extensive safety, environmental and performance testing" to ensure "all functional and performance specifications were met." This implies the acceptance criteria were compliance with a range of standards and internal functional specifications.

Reported Device Performance (Implicit): The device is considered to perform "as well as the legally marketed predicate devices" because it incorporates identical technology or modules from previously cleared devices and complies with relevant standards.

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

• Sample Size: Not specified. The testing mentioned refers to "final testing for the device" and "host tested at the previously noted OEM engineering test facility," which typically involve engineering verification and validation on a limited set of test inputs or simulated data, rather than a large patient-based test set for performance claims.
• Data Provenance: Not specified, but given the nature of the device (physiological monitor), testing would likely involve simulated physiological signals and possibly a small number of human subjects for usability and basic functionality, not large-scale retrospective or prospective patient data for algorithm performance validation.

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

This level of detail about expert-established ground truth is not applicable to this type of submission. The device is a physiological monitor, where parameters like ECG, heart rate, or blood pressure are measured directly using established sensor technologies, and their accuracy is typically validated against known reference standards or other calibrated devices, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC study is not applicable. This device is a monitor, not an AI-assisted diagnostic tool that interprets or provides clinical recommendations for human readers. It provides raw and processed physiological data. The document does not mention any AI components that would assist human readers in interpretation or diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device itself is a standalone physiological monitor. Its performance is evaluated on its ability to accurately measure and display physiological parameters. The "algorithms" mentioned (e.g., NIBP, 12-Lead ECG analysis software, SpO2) are components embedded in the device, and their performance is considered based on their prior clearance or established standards for those specific modules. No specific "algorithm-only" performance study distinct from the device's overall function is described.

7. The Type of Ground Truth Used:

For physiological measurements, the ground truth would typically be:

• Reference Standards: Calibrated instruments for known values (e.g., blood pressure cuffs calibrated against a mercury manometer, ECG simulators generating known waveforms).
• Predicate Device Comparison: Comparing measurements from the new device to those from a legally marketed predicate device.
• Pathology/Outcomes Data: Not typically used for a physiological monitor of this type.

The document states that the new device's NIBP measurement utilizes the "exact same technology and algorithm" as a previously approved monitor, and the 12-Lead ECG monitoring uses the "same" software module as a previous device. This implies that the ground truth for these components was established during the clearance of those predicate devices, likely through comparison to reference standards or established clinical methods.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physiological monitor built from established technologies and previously cleared modules. It does not describe a machine learning or AI model that requires a distinct "training set" in the context of contemporary AI/ML device development. The underlying algorithms for parameters like ECG analysis or pulse oximetry are fixed and well-understood.

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

Not applicable, as there is no mention of a distinct training set for an AI/ML algorithm within the context of this 510(k) submission. The ground truth for the components of the device (e.g., 12-Lead ECG analysis) would have been established during the development and clearance of those original component technologies, likely through extensive testing against known physiological signals and clinical validation studies at that time.

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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.

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The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.

The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and down arrow) on the front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.

This is a summary of the acceptance criteria and study information based on the provided text.

This submission describes a telemetry transmitter (Fukuda Denshi Model LX-7230KM/7230N) which is an interface device that transmits physiological data (ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate) from a patient to a central monitor. The core technology (ECG and Respiration measurement) is the same as the predicate device (LX-5630, [K033711](https://510k.innolitics.com/search/K033711)). The SpO2 measurement function integrates OEM modules from Konica Minolta (PULSOX-300/300i, [K053419](https://510k.innolitics.com/search/K053419)) and Nellcor (N-600x Pulse Oximeter, [K060576](https://510k.innolitics.com/search/K060576)), without modification to these modules or their sensors. The submission focuses on demonstrating substantial equivalence to the predicate device and the previously cleared OEM SpO₂ modules rather than presenting new clinical study data with specific performance metrics.

Acceptance Criteria and Device Performance

The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the Fukuda Denshi Model LX-7230KM/7230N Transmitter. Instead, the claim for substantial equivalence is based on the device incorporating identical fundamental technology for ECG and Respiration measurement as a predicate device and utilizing pre-cleared, unmodified SpO₂ modules whose performance has already been established and accepted by the FDA.

The "reported device performance" indicated is that the device "demonstrates that this device is as safe and effective as and performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." This implies that the device meets the performance standards already established for the predicate device and the incorporated OEM SpO₂ modules.

Study Details

The provided text describes a 510(k) submission seeking substantial equivalence for a medical device by demonstrating that its core technology is the same as a predicate device and that its SpO2 components are pre-cleared, unmodified OEM modules. Therefore, the "study" described is not a new clinical trial with specific performance endpoints, but rather a set of tests to confirm the new device's functionality and safety consistent with its predicate and incorporated components.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a patient-based sample size. The document mentions "extensive safety, environmental and performance testing" and "various performance tests." For the SpO2 modules, it states they were "host tested at the previously noted OEM engineering test facility."
   • Data Provenance: Not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be internal validation ("laboratory testing, validation and risk Analysis") and OEM engineering testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission relies on technical equivalence to established, cleared devices and modules rather than new ground truth establishment by experts for a new dataset.

3. Adjudication method for the test set: Not applicable. There is no mention of an adjudication process for expert consensus on a test set.

4. 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 applicable. This device is a telemetry transmitter and does not involve AI or human interpretation of medical images or data requiring an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed as a "standalone" performance study in the context of an algorithm. The device itself is a standalone transmitter. Its performance is demonstrated through its hardware and software functionality as an interface for physiological data, relying on the established performance of its component parts (ECG/Respiration from predicate, SpO2 from OEM modules).

6. The type of ground truth used: The "ground truth" for this submission is based on the performance established for:

   • The predicate device (Fukuda Denshi model LX-5630 Transmitter, K033711) for ECG and Respiration measurement.
   • The pre-cleared OEM SpO₂ modules (Konica Minolta "Pulsox-300/300i" K053419 and Nellcor "OxiMax N-600x Pulse Oximeter" K060576).
     The ground truth is implicit in the regulatory clearance of these prior devices and modules.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for an algorithm. The device's functionality uses established physiological measurement technologies.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.

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Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) 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), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. 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-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series 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-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) 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. An optional Battery Pack operation allows the DS-7210/7210M to be used to monitor patients during intra-hospital transport. 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-7000 Series Patient Monitor allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, temperature, invasive blood pressure (IBP), and cardiac output. This subject modified DS-7000 Series Patient Monitor extended the NIBP measurement target populations from adult and pediatric to adult. pediatric, and neonatal and the DS-7210/7210M of the DS-7000 Series includes ECG 12 Lead monitoring.

The DS-7000/7000M of the DS-7000 Series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG), which utilizes Criticare Systems technology (K012059), by using the option Multigas Unit (MGU-701/MGU-702) . And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. No new functions for the options are being added and are not the subject of this submission for the DS-7000/7000M.

This subject modified DS-7210/7210M of the DS-7000 series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), which utilizes Oridion Medical 1987 Ltd. technology "Microstream"" (K060065), by using the option CO2 measurement unit (MGU-722). Or, by using the option Mainstream CO2 interface Unit (MGU-721), the Capnostat 5 Mainstream CO2 Sensor (K042601) manufactured by Respironics Novametrix, LLC. is allowed to connect to the DS-7210/7210M with serial communication protocol for CO2 monitoring. And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 5 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored.

For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature.

The DS-7000 Series Patient Monitor is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 (for DS-7000/7000M) or 14 (for DS-7210/7210M) waveforms and up to 20 (for DS-7000/7000M) or 16 (for DS-7210/7210M) numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys (only DS-7000/7000M), or infrared remote-control command (optional). Additional standard features of the DS-7000 Series Patient Monitor include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions.

The DS-7000/7000M of the DS-7000 Series is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260mm (H) x 179mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138mm (H) x 82mm (D). No weight and physical dimensions are being changed and are not the subject of this submission for the DS-7000/7000M.

The subject modified DS-7210/7210M weight is 9.9 kg. The physical dimensions of the device are 310mm (W) x 351mm (H) x 245mm (D). The option CO2 measurement Unit (MGU-722) weight is 260g and Mainstream CO2 interface unit (MGU-721) weight is 200g. The both physical dimensions of the device are 141.5mm (W) x 41mm (H) x 79mm (D).

For the DS-7000 Series option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D). No weight and physical dimensions are being changed and are not the subject of this submission.

The provided text describes the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.

The document primarily focuses on:

• Description of the device: Its features, monitored parameters, and intended use.
• Predicate device comparison: Stating that it incorporates identical technology and is substantially equivalent.
• Safety and environmental testing: Mentioning compliance with various general and individual safety standards, and EMC standards.
• Conclusion: Reiterating that it's as safe and effective as predicate devices based on laboratory testing, validation, and risk analysis.

However, it lacks the specific quantitative data, sample sizes, ground truth establishment methods, or expert qualifications that would be detailed in a robust clinical or performance study report.

Therefore, I cannot populate the requested table and answer many of the specific questions directly from the provided text.

Here's a breakdown of what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Answers to Specific Questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified. The document only mentions "various performance tests" and "final testing."
• Data provenance: Not specified. The text indicates "laboratory testing" and testing at an "OEM engineering test facility." This suggests internal testing, but no details on patient data, if any, are provided. It does not mention if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The document describes compliance with technical standards and performance specifications, not diagnostic accuracy requiring expert ground truth in a clinical setting.

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

• Not applicable. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical studies, which is not described here.

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, an MRMC comparative effectiveness study was not done. This device is a patient monitor, not an AI-assisted diagnostic tool. The submission focuses on device safety and performance as a monitoring system.

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

• Not applicable in the context of an "algorithm only" study. The performance testing mentioned is for the integrated patient monitor system.

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

• For a patient monitor, the "ground truth" for performance testing typically refers to validated reference standards or simulated physiological signals that mimic real patient data with known values (e.g., a calibrated simulator for vital signs, or direct physical measurement for electrical safety parameters). The document does not explicitly state the specific type of ground truth used, but it would be based on these established engineering and physiological reference systems.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would have a separate "training set."

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Use of the Fukuda Denshi DynaScope Model DS-7000/7000M 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), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. 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-7000/7000M is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000/7000M 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-7000/7000M 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-7000/7000M allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), and cardiac output. By using the option Multigas Unit (MGU-701/MGU-702), the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), which utilizes Criticare Systems technology (K012059), oxygen concentration (O2), and anesthetic agent concentration (AG) are also possible. And, by using the option Unit (HU-71/HU-72/HU-73), blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. For the SpO2 measurement monitoring, the DS-7000 utilizes a Nellcor technology (K021090) and the DS-7000M utilizes a Masimo one (K033296).

The DS-7000/7000M is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 waveforms and up to 20 numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys, or infrared remote-control command (optional).

Additional standard features include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions.

The DS-7000/700M is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260 mm (H) x 179 mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138 mm (H) x 82 mm (D). The option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D).

Here's an analysis of the provided text regarding the Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor.

Based on the provided document, specific acceptance criteria and a detailed study proving the device meets these criteria in terms of analytical or clinical performance are NOT explicitly detailed.

The submission focuses heavily on substantial equivalence to predicate devices and adherence to various safety and performance standards rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to testing and general claims of performance:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria and corresponding reported device performance values (like sensitivity, specificity, accuracy for specific physiological measurements) are not provided in this 510(k) summary. The document focuses on demonstrating that the device is "as safe and effective and performs as well or better than the legally marketed predicate devices."

The "performance testing" mentioned generally refers to ensuring "all functional and performance specifications were met," which implies internal validation against design requirements, but these specific requirements are not listed publicly in this summary.

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

This information is not provided in the document. The text 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 suggests internal validation, but details on sample size or data provenance (e.g., country of origin, retrospective/prospective) are absent.

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

This information is not provided. Given the nature of a patient monitor, ground truth typically involves direct physiological measurements or calibration standards. However, the document does not elaborate on how "ground truth" was established for any performance testing.

4. Adjudication Method for the Test Set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or indicated in the document. This type of study is more common for diagnostic imaging AI rather than for patient monitoring devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study for an algorithm is not explicitly detailed in this document in the way it would be for a diagnostic AI. The device itself is a "patient monitor," implying continuous, standalone measurement of physiological parameters. However, the performance metrics (e.g., accuracy of HR measurement, SpO2 accuracy) are not presented as results of a formal standalone study with acceptance criteria.

The information suggests that the performance of component technologies (like SpO2, multigas) relies on their previous FDA clearances as separate OEM modules which would have undergone their own standalone validation (e.g., Nellcor, Masimo, Criticare).

7. Type of Ground Truth Used

The type of ground truth used for testing is not explicitly stated. For a patient monitor, ground truth would typically involve:

• Direct physiological measurements from reference instruments.
• Calibration standards for accuracy of sensors (e.g., temperature probes, blood pressure cuffs).
• Simulated physiological signals for testing algorithms like arrhythmia detection.

The document mentions that testing ensured "all functional and performance specifications were met," which would imply comparison against a form of ground truth or established standards, but the specific methodologies are not described.

8. Sample Size for the Training Set

This information is not provided. Patient monitors primarily apply established physiological measurement principles and algorithms rather than sophisticated machine learning models that require large "training sets" in the AI sense. While there might be internal algorithm development and tuning, the concept of a "training set" as it applies to deep learning AI is not relevant here, and therefore, no sample size is mentioned.

9. How Ground Truth for the Training Set Was Established

As the concept of a "training set" in the AI sense is not directly applicable to this type of device based on the provided information, the method for establishing ground truth for a training set is not discussed or provided.

Summary of Device Performance and Evidence from the Document:

While specific quantitative acceptance criteria are missing in this public summary, the document asserts that the device meets regulatory requirements through:

• Substantial Equivalence: The primary strategy detailed is demonstrating substantial equivalence to several legally marketed predicate devices (Fukuda Denshi DS-5300, DS-7141, Nellcor OxiMax N-560, Masimo SET RAD 5, Criticare 8500). This implies that the new device's performance is considered comparable to these cleared devices, which would have themselves met their own performance criteria upon clearance.
• Compliance with Standards: The device has been tested to assure compliance with a comprehensive list of general safety, individual product-specific (e.g., ECG, NIBP, SpO2), and EMC standards (UL60601-1, IEC series, ANSI/AAMI series, ISO series). Meeting these standards implies specific performance benchmarks for various physiological parameters (e.g., accuracy requirements for blood pressure, heart rate, SpO2). However, the specific results against these standards are not presented in this summary.
• OEM Module Reliance: Several key functions (SpO2, multigas) utilize previously cleared OEM modules from Nellcor, Masimo, and Criticare. The performance of these modules would have been validated during their own original 510(k) clearances.
• Internal Performance Testing: "Final testing for the device included various performance test ... to insure that all functional and performance specifications were met." This refers to internal company testing against their own design specifications.
• Risk Analysis and Validation: The conclusion states that the device draws from "laboratory testing, validation and risk Analysis" to demonstrate safety and effectiveness.

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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 cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi 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. This device is intended for Prescription Use Only

The Fukuda Denshi model DS-5000 series Telemetry Monitoring System consists of a series of interface devices which include a central transmitter receiver, an HLX-501 Multi-parameter transmitter, LX-5120 patient worn ECG/Respiration transmitters, and a Fukuda Denshi DS-5000 series Central Patient Monitor (K970585, K000746, K020084). The unit's are processor based software control devices. The receiver module can receive data for 4 or 8 patients and can be connected either directly or by local area network (LAN) to the DS-5000 series Central Patient Monitor. Each patient data when received at the central transmitter receiver is considered as a separate network node. Input signals are provided from the patient worn LX series transmitters or from the HLX-501 Multi-parameter transmitter when connected to a Fukuda Denshi DS-5000 series patient monitor.

Patient physiological data displays, controls, recordings and alarms are controlled from the Central Patient Monitor. Recordings can also be initiated from the bedside monitor or from the patient worn transmitters. System functions such as trending, arrhythmia and ST monitoring and data access are available to the user from the central monitor.

The HLX-501 multi-parameter transmitter may provide up to six waveforms and numeric data from the bedside monitor. Parameter monitored may include ECG, SpO2, Resp, BP, NIBP and Temp.

The patient worn LX-5120 transmitter provides monitoring of ECG and Respiration parameters.

The modified transmitter subject to this submission, the patient worn LX-5630 provides ECG and Respiration monitoring identically as the LX-5120 and adds SpO2 transmission through the integration of an Pulse Oximetry OEM module designed and manufactured by Konica Minolta Sensing Inc and cleared as the Minolta Pulseox-3 LI (K010413).

Acceptance Criteria and Device Performance:

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific sample size (number of patients or data points) for the "Verification and validation testing." The testing involved safety testing (electrical safety, EMC, radio telemetry) and pulse oximetry laboratory accuracy testing. The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. The testing aimed to confirm compliance with existing standards and predicate device performance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation. The testing focuses on technical performance and compliance with specifications and predicate device performance.

3. Adjudication Method for the Test Set:
Not applicable. The description does not involve a diagnostic interpretation or a need for adjudication among multiple reviewers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study focused on technical validation and comparison to a predicate device's established performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the testing described appears to be for standalone performance. The "Verification and validation testing" assessed the device's technical specifications, safety, and accuracy in transmitting and monitoring physiological data, and the accuracy of the integrated pulse oximeter module. This falls under the realm of evaluating the algorithm's and hardware's inherent performance.

6. Type of Ground Truth Used:
The ground truth for the technical and safety testing appears to be based on:
* Established specifications: Compliance with electrical safety, EMC, and radio telemetry standards.
* Predicate device performance data: Specifically, for pulse oximetry accuracy, the reference was the clinical testing results submitted with the Minolta PULSOX-3Li oximeter (K010413), which was a legally marketed and cleared OEM module.

7. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI. This device is described as a telemetry monitoring system with integrated hardware modules, not a machine learning-based diagnostic tool that would require a separate training dataset.

8. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning model is mentioned or implied for this device.

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Use of the Fukuda Denshi Model DS-7100 series Portable 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 and or invasive blood pressure, temperature and pulse oximetry. 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-7100 series is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7100 is also indicated where a hard copy record of the physiological parameters, the alarmed conditions or the trended values may be required.

The DS-7100 Series Patient Monitor is a pre-configured monitor meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU. CCU. OR or recovery areas of the hospital or clinic. An optional Battery Pack Operation allows the DS-7100 series to be used to monitor patients during intra-hospital transport. 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 systems recorder.

The DS-7100 series consist of two models. The base model DS-7010L allows for the monitoring of ECG, RESP, SpO2, BP NIBP and Temp. Model DS-7101LT offers all the monitoring features of the base model and adds an integrated WMTS 600 MHz telemetry transmitter, which uses the same basic design and control mechanism which was previously cleared, for use with the predicate device, as the Fukuda Denshi DS-5000 series telemetry model HLX-501 (K980728)

The DS-7100 series are self contained monitors which include an 8.4 inch TFT color LCD display which can display up to 6 waveforms. All input operation is performed on the monitors touch screen controls. Additional standard features include an Ethernet LAN for connection to Fukuda Denshi Central Stations, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously and an alarm pole feature on the top of device that alerts to alarm conditions through 9 corresponding flashing patterns.

The device is small and lightweight at 5.2 kg. The physical dimensions of the device are 260mm (W) x 264 mm (H) x 196 mm (D). Because there is no need for a cooling fan operation is extremely quite. The AC power supply includes the battery charger for the optional battery operation to allow intra-hospital transport of patients. Use of low power, high speed flash memory allows for easy software upgrades though a standard PMCIA compatible IC card.

The provided text is a 510(k) summary for a medical device (Fukuda Denshi DS-7100 Series Portable Patient Monitor) being modified. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's description and intended use.

Crucially, this document does NOT contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

510(k) submissions, especially "Special 510(k)" for device modifications, often refer to performance standards and specifications that the device meets, but they don't always detail the specific studies and acceptance criteria in the summary document intended for public release. The focus of this type of submission is typically on showing that the modified device performs as safely and effectively as its predicate, adhering to existing performance specifications rather than establishing new ones through a detailed performance study described in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The document states that any safety issues for software-controlled medical devices are either "the same issues already addressed by the predicate devices or are addressed the system hazard analysis, or in the system validation." This implies that the current submission relies on previous clearances and internal validation documentation rather than presenting new, detailed performance study data in this summary.

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