(197 days)
The Nihon Kohden CSM-1901 Bedside Monitor is 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 alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, enflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit.
The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
The Bedside monitor CSM-1901 is a device which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU, HCU, NICU and an emergency room. This bedside monitor is placed near the patient and is intended to display patient's vital signs. This device can also be connected to other external patient monitoring devices. In addition, this device can communicate patient's data to a central monitoring station via network to monitor multiple patients.
Here's an analysis of the provided text regarding the Nihon Kohden CSM-1901 Bedside Monitor, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details compliance with recognized standards and internal testing protocols. It does not contain specific, detailed acceptance criteria in quantitative terms (e.g., sensitivity, specificity for arrhythmia detection) or a robust clinical study with detailed performance metrics like one might find for a novel AI device or a PMA submission. Therefore, some sections below will indicate that the information is not present in the provided document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (Summary) |
|---|---|
| Arrhythmia Detection & Alarming: | Functions as intended to generate visible and/or audible alarms when an arrhythmia exists. |
| Physiological Data Monitoring: (HR, SpO2, NIBP, IBP, Temp, BIS, CO, FiO2, CO2, EtCO2, Resp. Rate, Anesthetic Agents/Gases) | Continuously monitors, displays, and records physiological information for all listed parameters. |
| Alarm Generation: | Generates audible and/or visual alarms when a measured rate falls outside preset limits. |
| Patient Populations: | Available for use on all patient populations (adult, neonate, infant, child, adolescent). |
| Display Features: | Enhanced display features including improved resolution, increased number of traces, increased number of sweep speeds, and moving trace capability. |
| Connectivity/Interoperability: | Connects to external monitoring devices and communicates data to a central monitoring station. Includes an interface to the AE-918P EEG monitor Neuro Unit. |
| Storage Capacity: | Increased storage capacity for Arrhythmia Recall Files. |
| Electrical & EMC Safety: | Complies with ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2007-03, and other relevant IEC 60601 series standards (as listed). |
| Alarm Systems: | Complies with IEC 60601-1-8:2012-11. |
| Software Functionality: | Software unit testing, integration testing, system verification (GUI), and system validation completed. |
| Substantial Equivalence: | Demonstrated substantial equivalence to the Nihon Kohden BSM-9100A Bedside Monitor, with differences being minor and not raising safety/efficacy concerns. |
Missing Specific Quantitative Acceptance Criteria: The document does not provide specific quantitative acceptance criteria for the performance of arrhythmia detection (e.g., minimum sensitivity or specificity targets for specific arrhythmia types), or for the accuracy and precision of physiological measurements against a gold standard. The performance is generally stated as "functions as intended" or "complies with standards."
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient data or physiological recordings used for clinical performance evaluation. The testing described is primarily in the context of engineering verification and validation (software, electrical safety, EMC, etc.).
- Data Provenance: Not applicable, as no specific patient data test set is described.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. The document describes engineering and systems testing, not a clinical trial involving expert-labeled ground truth.
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Adjudication Method for the Test Set:
- Not applicable. No clinical test set with adjudicated ground truth is described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done (or at least not reported in this 510(k) summary). The device is a "bedside monitor" with integrated detection algorithms, not an AI-assisted diagnostic tool that augments human interpretation in a comparative reader study context.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no such study was conducted or reported.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence, standalone performance was assessed though not in the form of a detailed clinical "study" with specific performance metrics for individual algorithms. The device's integrated arrhythmia detection and physiological measurement algorithms are designed to operate independently to generate alarms and display data. The testing mentioned (software unit testing, integration testing, system verification, system validation) would cover the standalone functionality of these algorithms and systems against their specifications. However, specific performance metrics (e.g., for arrhythmia detection accuracy against a recognized benchmark dataset like MIT-BIH) are not
detailed in this summary.
- Yes, in essence, standalone performance was assessed though not in the form of a detailed clinical "study" with specific performance metrics for individual algorithms. The device's integrated arrhythmia detection and physiological measurement algorithms are designed to operate independently to generate alarms and display data. The testing mentioned (software unit testing, integration testing, system verification, system validation) would cover the standalone functionality of these algorithms and systems against their specifications. However, specific performance metrics (e.g., for arrhythmia detection accuracy against a recognized benchmark dataset like MIT-BIH) are not
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Type of Ground Truth Used:
- For the engineering and systems testing, the "ground truth" would be established by:
- Defined specifications: Software units and system functions were tested against their intended design and functional requirements.
- Standardized test signals/simulators: Electrical and EMC tests, and possibly some physiological parameter accuracy checks, would use calibrated test equipment and signals representing known conditions.
- Compliance to standards: The ground truth for safety and performance would be the requirements laid out in the cited IEC and ANSI/AAMI standards.
- Predicate device comparison: Functional equivalence was likely established by comparing the new device's behavior to the predicate device under similar test conditions.
- For the engineering and systems testing, the "ground truth" would be established by:
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Sample Size for the Training Set:
- Not applicable. The document does not describe the use of machine learning or AI in a way that requires a "training set" for model development. This seems to be a traditional medical device employing established signal processing and rule-based algorithms. Therefore, there's no mention of a training set.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set is mentioned for AI/ML model development.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.