(150 days)
The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® System with MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Alaris® System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
As with the predicate device, the Alaris® System with MMS assists our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to a server and an existing infusion device (the Alaris® System). The wireless communication capability provides a "safety net" at the bedside to help reduce the number of programming errors at the point of care. It allows the Alaris® System to transmit and receive messages with the Alaris® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA;s), hospital monitoring systems and Hospital Information Management Systems (HIMS).
Here's an analysis of the provided text regarding the Alaris® System with MMS, focusing on acceptance criteria and study details.
Based solely on the provided document snippets, it is not possible to provide a table of acceptance criteria, reported device performance, or detailed study information typically associated with AI/ML device evaluations.
This document is a 510(k) summary for a Special 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device for modifications that do not raise new issues of safety or efficacy. It is explicitly stated: "The changes as described in this Special 510(k) pose no new issues of safety or efficacy."
Therefore, the information you're asking for (acceptance criteria, specific study results for performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is not present in this type of submission for this particular device.
This device is an infusion pump system with wireless communication capabilities, designed to automate programming and reduce manual steps. It is a traditional medical device, not an AI/ML device that would typically undergo the kind of performance validation studies you're inquiring about. The "MMS" stands for "Medication Management System," implying software for managing medication regimens, but not necessarily AI for diagnosis or treatment recommendations.
To directly address your request, here's what can be inferred from the document and why other information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable and not provided in the document. A Special 510(k) for changes that maintain substantial equivalence does not typically present new performance criteria and results beyond what was established for the predicate device. The focus is on demonstrating that the changes do not degrade performance or introduce new risks.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable and not provided. Performance studies with test sets in the context of AI/ML are not detailed because this is not an AI/ML device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable and not provided. "Ground truth" in the context of AI/ML for diagnostic or predictive tasks is not relevant here. The device automates infusion programming; its "accuracy" would be against a physician's order or internal calculations, not an expert panel.
4. Adjudication Method
Not applicable and 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
Not applicable and not provided. This is not an AI diagnostic/interpretive device; therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable and not provided. There's no "algorithm" in the AI/ML sense being evaluated independently. The device's function is to facilitate automated programming by "trained healthcare professional[s]".
7. The Type of Ground Truth Used
Not applicable and not provided.
8. The Sample Size for the Training Set
Not applicable and not provided. AI/ML training concepts are not relevant to this device's submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable and not provided.
Summary of Device and Acceptance Logic (based on the provided text):
- Device Name: Alaris® System with MMS (Medication Management System)
- Intended Use: To provide wired or wireless communication between the Alaris® System and external devices to automate programming of infusion parameters, decreasing manual steps. All data entry and validation are performed by a trained healthcare professional.
- Predicate Device: Alaris® System with MMS (a.k.a. Medley™ System with MMS) K030459
- Acceptance Logic (for this Special 510(k) submission): The device is substantially equivalent to its predicate device because it "has the same intended use, operating principles, method of operation, technology, materials and manufacturing processes." The changes described in this Special 510(k) "pose no new issues of safety or efficacy." This means the acceptance criterion for this specific submission was demonstrating that the modifications did not alter the fundamental safety and effectiveness already established for the predicate device. The "study" demonstrating this was likely a comparison of technical characteristics and an analysis showing that the changes (e.g., wireless communication capabilities) did not introduce new risks or alter the core functionality negatively.
In essence, this document is a regulatory approval for a non-AI medical device based on substantial equivalence, not a performance study report for an AI/ML system.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).