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The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

Here is an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.

2. Sample size used for the test set and the data provenance

The provided text does not explicitly state a specific sample size for a "test set" in the context of clinical performance or diagnostic accuracy. Instead, the submission relies on:

• Non-clinical bench testing: This refers to laboratory-based evaluations of the device's technical specifications and performance against engineering requirements and established standards. The text does not detail the "sample size" of this type of testing (e.g., how many units were tested, how many times).
• Electrical safety and electromagnetic compatibility (EMC) testing: Performed on the devices to comply with standards like ANSI AAMI ES60601-1 and IEC 60601-1-2. No sample size is mentioned.
• Software verification and validation (V&V): This included unit, integration, and system-level testing based on software requirements. Again, specific "sample sizes" (e.g., number of test cases, patient data used for simulated testing) are not provided in this summary.
• Comparison to a predicate device (Nihon Kohden CSM-1901, K201949): The primary evidence for substantial equivalence is based on demonstrating that the subject devices (Life Scope G5 and G7) have identical intended use, indications for use, principles of operation, and performance specifications to the predicate, with minor differences explicitly addressed and deemed not to affect safety or effectiveness. The performance of the predicate device itself would have been established through its own clearance process, which likely included clinical and non-clinical data. However, for the subject devices, no new clinical studies with patient data (and thus no specific "test set" sample size or data provenance) beyond what the predicate relied upon are detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Given that no explicit "test set" with ground truth established by experts is described for the subject devices, this information is not provided in the text. The submission focuses on technical equivalence and compliance with standards rather than a new clinical study requiring expert-adjudicated ground truth.

4. Adjudication method for the test set

Since no specific test set requiring expert adjudication for ground truth is described, the adjudication method information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not mentioned or described in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device through technical comparison and compliance testing, not a comparative clinical study.

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

The document mentions "Multi-template software algorithm" for arrhythmia detection and "ECAPS12C" for ECG interpretation. This indicates that standalone algorithmic performance is part of the device's function. However, the document does not provide standalone performance metrics (e.g., sensitivity, specificity for arrhythmia detection or ECG interpretation) obtained from testing the algorithm in isolation. Instead, it states that "Software verification and validation testing were conducted," which would include testing of these algorithms. The performance is implicitly covered by the device's overall compliance with standards like ANSI/AAMI/EC57, which specifies testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms.

7. The type of ground truth used

For the software verification and validation, and potentially for the standards compliance (e.g., ANSI/AAMI/EC57 for ECG algorithms), the ground truth would likely be established through:

• Reference standards/simulated data: For technical specifications and algorithm testing, synthetic or pre-recorded standardized waveforms (e.g., from databases like MIT-BIH Arrhythmia Database) with known ground truth annotations are typically used.
• Predicate device performance: The "ground truth" for showing substantial equivalence is the established performance and safety profile of the predicate device itself.

The document does not explicitly state the specific type of ground truth used for any newly generated data for the subject devices, but it implicitly relies on established testing methodologies for medical devices and their components.

8. The sample size for the training set

The document does not provide information on the sample size for any training set. This is generally because the submission is for a medical device with established technological characteristics, not a novel AI/machine learning device that would typically involve a separate training phase with a distinct dataset size. The "Multi-template software algorithm" for arrhythmia detection suggests an algorithm developed or trained previously, but details of its training are not part of this 510(k) summary.

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

As no training set is described for the subject devices in this 510(k) summary, the method of establishing its ground truth is not provided. If the algorithms were previously trained, it would have been done during their initial development, likely using expert-annotated physiological data.

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