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Use of the Fukuda Denshi model DS-7141 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, STlevel and yentricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature, pulse oximetry and/or CO2. 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-7141 is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7141s also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The DS-7141 Portable 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-7141 to be used to rouito, 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-7141 is an addition to the DS-7100 Series Patient Monitor Line up. (K032290). It is the same as the predicate devices in that it uses identical hardware and software which allows for the monitoring of EEC, RESP, SpO2m BP, NIBP and Temp. It additionally includes identical telemetry capabilities as the predicate. The DS-7141 adds EtCo2 monitoring capability to the DS-7100 series of Portable Patient Monitors by the integration of a MediCO2 MicroStream TM module which was designed and manufactured by Oridion and previously cleared under 510(k) (K964239).

The DS-7141is a 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 provided text describes a 510(k) submission for the Fukuda Denshi DS-7141 Portable Patient Monitor, focusing primarily on its equivalence to previously cleared devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table for the DS-7141 itself, beyond general "performance specifications" being met. The core of this submission relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.

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

The document does not specify a distinct "test set" with a defined sample size in the context of clinical data for algorithmic performance. The testing described is more aligned with product verification and validation (safety, environmental, performance specifications, and adherence to standards) rather than a clinical trial evaluating algorithmic accuracy against a ground truth dataset in the typical sense of AI/ML device testing.

The provenance of data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as it does not appear to be a study of patient data.

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

Not applicable. This submission is about a patient monitor with integrated components, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of output to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No. The document makes no mention of an MRMC study or any studies involving human readers, with or without AI assistance. The device is a patient monitor, not an interpretive AI system for imaging or other complex data.

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

Not explicitly a "standalone" algorithmic study in the modern sense. The "host testing" of the integrated MediCO2 MicroStream™ module at the OEM facility would evaluate its performance specifications in isolation before integration, which could be considered a form of standalone testing for that specific component. However, this is for a physiological measurement device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

• Engineering Specifications and Benchmarks: For parameters like accuracy of measurements (ECG, SpO2, NIBP, Temp, EtCO2), stability, and response times.
• Standardized Test Conditions: Environmental testing (temperature, humidity, vibration), electrical safety tests.
• Reference Devices: Performance of integrated modules (e.g., EtCO2) would be compared to known accurate reference devices or established functional standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML algorithm that would have a "training set" in the context of machine learning model development.

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

Not applicable, as there is no described training set for an AI/ML algorithm.

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