(508 days)
The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiology and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.
The ARC System software is intended to be used by healthcare professionals for the following purposes:
- · To remotely consult, regarding a patient's status
- · To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care
- · To create and manage Patient Prioritization Rules
- · To access Patient Prioritization information
WARNING:
- Rx Only.
- · Do not use the ARC System as an active patient monitoring.
- · Do not use the ARC System to replace any part of the hospital's device monitoring.
- · Do not rely on the ARC System software as the sole source of patient status information.
The ARC ICU Information System is intended to provide the Intensive Care Unit (ICU) with clinical decision support, workflow management, interoperability and device connectivity. The system receives near real-time data from medical devices in the ICU and presents them on a single dashboard to provide secondary clinical decision support. Patient vitals from ventilators, monitors, pumps, smart beds, IoT sensors etc. are connected to the ARC Box. From the ARC Box, data is propagated through the ARC software, and displayed on a central monitoring system, the ARC DS. The data is available on remote monitoring devices, such as a mobile device or physician tablet. The ARC System is composed of a physical hardware component (ARC Box), which interfaces with the ICU medical devices, and the ARC System Software components.
Decision support algorithms, treatment protocols and applications used within ARC System do not come with a predefined procedure or standard. A skilled health care professional can use ARC System to create and define a healthcare workflow dynamically on the basis of an individual hospital, clinic or physician. ARC ICIS is a Web-based and Cloud Ready system that is built on IoMT and BigData technologies. It is intended to provide reliable and secure access to patient information.
ARC Box is a vendor-neutral connectivity solution that retrieves patient data from different device makers and transfers this data, via serial ports and/or ethernet ports, to a central dashboard. It is built on IoT for secure and quick communication between medical devices while gathering rich data. It temporarily stores data in the event of unexpected circumstances such as power outage or server failure and transfers saved data to ARC ICIS to be visualized for Clinical Decision Support.
This document is a 510(k) Premarket Notification from Ordinatrum Solutions to the FDA for their ARC Intensive Care Information System (ARC System). It aims to demonstrate substantial equivalence to a predicate device (K142106 - Decision Health Patient Dashboard).
However, the provided text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it mentions "Performance testing to demonstrate substantial equivalence" and "Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications," but it does not provide a table of acceptance criteria, the reported device performance against those criteria, or a detailed breakdown of methodology (sample sizes, expert involvement, ground truth establishment, or an MRMC study). The human factors usability study is mentioned, but it is not framed as a study to prove the device meets specific functional or performance acceptance criteria for, for example, patient prioritization rule accuracy or remote data review.
Therefore, I can only extract limited information from the provided text based on your request.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that "Performance testing... demonstrated that the ARC System meets its specifications" but does not list these specifications as explicit acceptance criteria with corresponding performance data.
2. Sample sizes used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for performance testing.
- A human factors usability study was conducted with "30 typical users (15 intensivists and 15 critical care nurses)." This is a sample size for a usability study, not for a core performance test (e.g., accuracy of rule-based algorithms).
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document does not describe the establishment of a "ground truth" for evaluating the performance of its rule-based algorithms or data display. The human factors study involved "typical users" (intensivists and critical care nurses), but their role was in a usability study, not in establishing a ground truth for algorithm performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
An MRMC study is not mentioned or implied. The device is an "intensive care information system" for aggregating, displaying, and managing patient information, and allowing healthcare professionals to define rule-based algorithms for notifications. It is not an AI-assisted diagnostic imaging tool where an MRMC study would typically be conducted to assess reader improvement. The warning explicitly states: "Do not use the ARC System as an active patient monitoring. Do not use the ARC System to replace any part of the hospital's device monitoring. Do not rely on the ARC System software as the sole source of patient status information." This suggests its role is primarily data aggregation and rule-based notification, not AI-driven diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states, "Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications." This implies that various technical tests were performed without direct human-in-the-loop interaction for the specific functions being tested (e.g., data connectivity, data propagation), but it doesn't specify an "algorithm only" performance study in the context of diagnostic accuracy. Given the device's function (rule-based algorithms defined by healthcare professionals, not pre-defined AI algorithms for diagnosis), a standalone "algorithm only" performance evaluation in the typical sense (e.g., for diagnostic accuracy) is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided.
8. The sample size for the training set:
The document does not mention a training set. The ARC System appears to be a rule-based system where healthcare professionals define the rules, rather than a machine learning/AI system that would require a distinct training set.
9. How the ground truth for the training set was established:
Since a training set is not mentioned, the method for establishing its ground truth is also not applicable or provided.
Summary of Device and Performance Information Mentioned (but lacking specific detail on meeting acceptance criteria):
- Device Name: ARC Intensive Care Information System (ARC System)
- Intended Use: Aggregating, displaying, and managing physiology and other patient information. Collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. Allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.
- Purposes for Healthcare Professionals: Remotely consult on patient status; remotely review near real-time patient data, waveforms, and alarms to aid clinical decisions; create and manage Patient Prioritization Rules; access Patient Prioritization information.
- Testing Conducted:
- Performance testing to demonstrate substantial equivalence.
- Unit, integration, security, vulnerability, and system level testing (stated to have demonstrated that the ARC System meets its specifications).
- Human factors usability study (30 typical users: 15 intensivists, 15 critical care nurses).
- Conclusion: The manufacturer asserts that the testing demonstrated substantial equivalence to the predicate device and that differences do not raise significant new questions of safety or effectiveness.
To reiterate, the provided text is a standard FDA 510(k) summary focusing on substantial equivalence to a predicate device. It highlights that testing was done to meet specifications but does not provide the granular detail about set acceptance criteria and the results of specific performance evaluations against those criteria, which you requested.
§ 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).