(266 days)
Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.
Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices. When Central Station is connected with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the Central Station can:
• Admit and discharge patients on the Nihon Kohden network.
• Display and manage compatible devices' real-time patient clinical data, vital signs, alarms and waveforms.
• Review and trend data calculated by connected Nihon Kohden devices.
• Store and transfer historical clinical data for the connected systems.
• Print patient data.
Central Station is intended for use in professional medical facilities by trained medical personnel.
Central Station is software only product that is installed on a Commercial Off the Shelf (COTS) Computer.
Central Station displays waveforms data and numerical data from a connected bedside monitor, vital sign telemeter, or multiple patient receiver unit on the screen.
Central Station is a network device, intended to provide remote patient monitoring to medical personnel. Central Station displays a list of measured values and a trend graph. Numerical data and various waveforms are color-coded for each parameter. Central Station also has the function of displaying an alarm.
Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment.
The provided document is a 510(k) clearance letter for the "Central Station" device. This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific performance acceptance criteria and study results in the same way as a full clinical trial report or a detailed design validation report would.
The document states:
- "Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices."
- "Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment."
- "The results of the substantial equivalence assessment, taken together with non-clinical bench testing, software verification, and validation demonstrate that the Central station does not raise concerns regarding its safety and effectiveness compared to its predicate device and operates in accordance with claimed indications for use."
Given these statements, the "Central Station" device is essentially a display, recording, and communication hub. It does not perform diagnostic algorithms or make independent judgments that would typically necessitate the kinds of detailed performance metrics (like sensitivity, specificity, or reader agreement) that are usually established through extensive multi-reader, multi-case (MRMC) studies with expert ground truth. Its primary function is to accurately display and relay data processed by other Nihon Kohden devices.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific device (Central Station) would primarily revolve around:
- Software Verification and Validation (V&V): Ensuring the software correctly displays, records, and transmits data as designed, and that all features (admit/discharge, trend display, printing, network communication) function as intended without errors.
- Non-Clinical Bench Testing: Confirming interoperability with compatible devices, accuracy of data display, alarm relay, and network functionality.
- Cybersecurity Compliance: Meeting regulatory requirements for cybersecurity.
The document explicitly states that "The software documentation was prepared following the FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (released June 14, 2023), specifically for an Enhanced Documentation Level." and "Verification testing was conducted at the system integration level to confirm that the device software fulfills its requirements and that safety and security risk mitigations, where applicable, were effective. Additionally, system-level testing was carried out to show that the software addresses user needs. All unit, integration, and system-level tests successfully met the test protocols."
Based on the provided text, it is not possible to extract the specific quantitative performance metrics (like sensitivity, specificity, or effect sizes for human readers) that would be relevant for a device performing complex data processing or diagnostic functions. The document emphasizes substantial equivalence and basic functional verification, not advanced AI/diagnostic performance validation.
However, I can infer the spirit of typical acceptance criteria and how a device like this would be proven to meet them, guided by the information provided.
Inferred Acceptance Criteria and Device Performance for "Central Station"
Given the device's stated function (display, record, print, and relay data without processing it for diagnosis or alarm judgment), the acceptance criteria would focus on functional correctness, data integrity, interoperability, and system reliability, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Functional Performance | 1. Data Display Accuracy: All physiological data (waveforms, numerics, alarms) received from connected compatible devices are accurately and synchronously displayed. | "Display and manage compatible devices' real-time patient clinical data, vital signs, alarms and waveforms." "Numeric data and various waveforms are color-coded for each parameter." Implied: Accuracy of display confirmed via functional tests against known inputs from connected devices. |
| 2. Data Recording & Storage: Historical clinical data, trends, and events are accurately stored and retrievable for the specified durations/files. | "Store and transfer historical clinical data for the connected systems." Review history data storage (e.g., Trendgraph: 120 hours, Arrhythmia recall: 1,500 files, Event list: 10,000 files). Implied: Storage and retrieval validated against specified capacities and data integrity checks. | |
| 3. Printing Functionality: Patient data can be accurately printed, including specified parameters like patient info, waveforms, and trends. | "Print patient data." Ability to print various review windows (Trend, Full Disclosure, Arrhythmia Recall, etc.). Implied: Printing validated for completeness and accuracy of generated reports. | |
| 4. Patient Management: Functions for admitting, discharging, pausing, and transferring patients within the network operate correctly. | "Admit and discharge patients on the Nihon Kohden network." Support for Admit, Discharge, Pause, Transfer functions (within one CS, between CSs, manual/auto entry). Implied: Workflow and data handling for patient management validated. | |
| 5. Alarm Relay: Alarms generated by connected bedside monitors are accurately received and displayed/mimicked by Central Station. | "Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor... Central Station itself does not have the function to perform alarm indication judgment." Implied: Alarms from connected devices are correctly received and presented as per design. | |
| Interoperability & Connectivity | 1. Compatible Device Connection: Successful and stable connection to all specified Nihon Kohden bedside monitors, telemetry receivers/transmitters. | Compatible with NK Bedside Monitors (BSM: 1700, 3000, 6000, G9, G5, G7), Vital Signs Monitor (SVM-7200), NK Telemetry (GZ-120/130/140), Multiple Patient Receiver/Transmitters (ORG-9700/9100, ZS-940, ZM-520/521/530/531), Central Monitor (CNS-6201/6801/2101). Max 32 connections. Implied: Connectivity and data exchange verified through testing with all listed compatible devices. |
| 2. Network Communication: Reliable communication via NET-9/LS-NET protocol within the Nihon Kohden network. | "Network: Yes (NK Network)." "Communication protocol: NET-9/LS-NET communication." Implied: Network communication validated for stability, data integrity, and compliance with protocol. | |
| Software Quality & Reliability | 1. Software Functionality: All software features operate as per specifications without critical errors or crashes. | "Verification testing was conducted at the system integration level to confirm that the device software fulfills its requirements... All unit, integration, and system-level tests successfully met the test protocols." Implied: Comprehensive software V&V confirmed functional correctness and absence of defects. |
| 2. Cybersecurity: Device adequately mitigates cybersecurity risks and complies with relevant guidance. | "Cybersecurity information has been provided in line with the FDA's 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' guidance document, dated September 27, 2023." "Interoperability-related risk management activities are included in Cybersecurity Risk Management activities." Implied: Security testing confirmed adherence to cybersecurity standards. | |
| Risk Management | 1. Safety & Effectiveness: Risks associated with interoperability, anticipated users, and foreseeable misuse are adequately addressed. | "The CENTRAL STATION has been designed and verified through a risk analysis that considers the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation." Implied: Risk analysis documented and mitigation verified, ensuring the device does not raise new safety/effectiveness concerns compared to the predicate. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data for diagnostic algorithms, because the device doesn't perform diagnostic processing. The "test set" for this device would be a collection of test cases covering all functional requirements, interoperability scenarios with different compatible devices, alarm conditions (relayed), data storage limits, network loads, and user interaction flows. The document mentions "system integration level" and "system-level testing" and that "all unit, integration, and system-level tests successfully met the test protocols." This implies a comprehensive set of non-clinical, bench-level tests.
- Data Provenance: Not applicable in the sense of clinical patient data (e.g., from specific countries, retrospective/prospective studies), as the device does not process primary patient data for diagnosis. The data used for testing would be simulated, generated, or derived from compatible Nihon Kohden monitor outputs in a lab setting to verify the Central Station's display and communication functions.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable in the traditional sense for diagnostic AI. The ground truth for this device's performance would be the expected output based on its functional specifications and the known inputs from the connected Nihon Kohden devices. For example, if a connected monitor transmits an HR of 70 bpm, the ground truth is that the Central Station must display 70 bpm. These "ground truths" are established by engineering design specifications, not human expert consensus on clinical findings.
- Experts Involved: Software engineers, quality assurance engineers, subject matter experts on the physiological monitoring systems, and potentially clinical users for usability and workflow testing. Their qualifications would be in device design, software development, testing, and clinical application.
4. Adjudication Method for the Test Set
- Not Applicable in the context of clinical interpretation adjudication (e.g., 2+1 radiologist consensus). Adjudication in this context would be internal to the software development and testing process:
- Test Pass/Fail Criteria: Predetermined pass/fail criteria for each test case.
- Bug/Defect Resolution: Issues found during testing are logged as bugs, investigated by engineers, and resolved, followed by retesting.
- Verification Sign-off: Test leads or design engineers review test results and formally sign off on the successful completion of verification.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, not performed for this device. An MRMC study is relevant for AI systems that assist human readers in making diagnostic decisions (e.g., radiologists reading X-rays with AI assistance). The Central Station device does not perform any such diagnostic assistance; it merely displays data from other (likely already cleared) devices. Its function is analogous to a monitor or a remote display unit, not a diagnostic AI.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This device does not have a "standalone algorithm" that performs diagnostic or data processing functions independently. Its function is entirely dependent on receiving data from other compatible Nihon Kohden devices.
7. Type of Ground Truth Used
- Functional Specifications and Truth from Connected Devices: The ground truth for this device is based on its functional design specifications (e.g., "display received data," "store data for X hours," "print Y parameters") and the verified output from the connected Nihon Kohden bedside monitors and telemetry systems. It's about data integrity and display accuracy, not clinical outcomes or pathology.
8. Sample Size for the Training Set
- Not Applicable. This device is described as "software only product" that "does not perform any data processing on the data received," and "Central Station itself does not have the function to perform alarm indication judgment." This strongly implies it is a rule-based or deterministic system, not a machine learning/AI system that requires a "training set" in the common sense (i.e., for learning patterns from data for prediction or classification). Therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, there is no corresponding ground truth establishment process for a training set.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).