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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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