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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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