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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-7000/7000M 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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