(84 days)
The device 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 monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.
The device is a multi-parameter monitor consisting of a color LCD touchscreen to display waveforms and numerics of monitored parameters, multi-parameter input unit (socket for input cables), and a removable battery pack. Options include a built-in thermal array recorder and network communication card. The device is software driven.
The provided document describes a 510(k) notification for the Nihon Kohden BSM-2300A Series Bedside Monitor. The primary focus of the performance testing section is on compliance with electrical safety, electromagnetic compatibility, and general functional specifications, rather than detailed clinical performance metrics for arrhythmia detection or specific vital sign monitoring accuracy.
Therefore, many of the requested elements regarding acceptance criteria for specific clinical performance, sample sizes for test sets with ground truth, expert adjudication, or MRMC studies are not available in the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized electrical and safety standards and internal product specifications.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 (Lead Wires and Patient Cables) | Device complies. |
| Compliance with applicable performance standards | Device is designed to and the completed testing showed it met the following standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Amendment 1 (1996-09), AAMI EC 12-27 (1994), IEC 60601-2-30 (1995-03), IEC 60601-2-34 (1994-12). |
| Biocompatibility of patient-contacting accessories | Disposable SpO2 probes use 3M Nonwoven Medical Tape (No. 1776), which was tested in accordance with ISO 10993. The manufacturer (3M) attests to the biocompatibility of adhesive materials within historically acceptable levels. |
| Environmental Testing (temperature/humidity stress, EMI/EMC) | Completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. |
| Safety Standards Testing | Completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. |
| Software Functionality | Product verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications. |
| Overall Safety and Effectiveness | No significant changes in function, biocompatibility, performance, or manufacturability compared to the predicate device that would affect the safety and effectiveness. (This is a statement of substantial equivalence, not a direct performance metric). |
| Arrhythmia Detection & Alarms | The document states the device is intended to monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. No specific performance metrics (e.g., sensitivity, specificity, accuracy) for arrhythmia detection are provided in the text. |
| Other Vital Sign Monitoring (HR, PR, SpO2, NIBP, IBP, Temp, CO2, Resp) | The document states the device is intended to monitor these parameters and generate alarms when a measured rate falls outside preset limits. No specific performance metrics (e.g., accuracy against a gold standard) for these parameters are provided in the text. |
Note: The provided text does not include specific numerical acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, or accuracy ranges for vital signs) nor corresponding reported numerical device performance for such criteria. The performance testing described is focused on engineering and safety standards compliance and internal product specifications.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for clinical performance. The document mentions "product verification and validation" for software and "completed testing" for environmental/safety, but no sample sizes for patients or data points are provided.
- Data Provenance: Not specified. Given the nature of the testing described (compliance with standards, software validation, environmental), it likely involved in-house engineering testing rather than patient data collected from a specific country. If patient data was used for validation of arrhythmia or vital signs, it is not mentioned.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. The document does not describe the establishment of ground truth for clinical performance using human experts. The testing described focuses on engineering and safety compliance.
4. Adjudication method for the test set
Not applicable/Not specified. There is no mention of clinical test sets requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bedside monitor with automated arrhythmia and vital sign detection/alarms, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance. The technology described predates widespread "AI" as we understand it in medical devices today.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The device itself is designed to perform monitoring, detect arrhythmias, and generate alarms without continuous human intervention. The testing described (compliance with standards, software functionality) would inherently evaluate the device's standalone performance against its specifications and the requirements of the standards. However, specific standalone performance metrics (e.g., sensitivity/specificity for arrhythmia without human review) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., IEC 60601-1, AAMI EC 12-27). For software, the ground truth would be the expected functional behavior defined in the product specifications.
8. The sample size for the training set
Not applicable/Not specified. This document is for a conventional medical device (bedside monitor) from 2001 and does not describe machine learning or AI models requiring training sets as typically understood in current contexts.
9. How the ground truth for the training set was established
Not applicable/Not specified, as no training set for a machine learning model is mentioned.
§ 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.