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The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alario® System module is specified in its respective submission.

The Alaris® System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris® PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris® System.

This document is a 510(k) premarket notification for an Alaris® PC Unit (Models 8000 and 8015). It details the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a device modification for the Alaris® PC Unit, specifically including "a faster processor, increased memory, and a color screen." The submission's core argument is one of substantial equivalence to a previously cleared predicate device (Alaris® PC Unit K051641).

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device "is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." This means the device is expected to perform at least as well as the predicate device in its intended function.

Since this is a 510(k) for a device modification and not a new diagnostic algorithm or AI, there are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the provided text. The performance is assessed by comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

This document is for a medical device modification (an infusion pump's control unit), not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical studies (e.g., patient data, images) are not applicable here. The evaluation is based on engineering and design changes, and comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. As noted above, this is for a medical device modification, not a clinical diagnostic algorithm requiring expert-established ground truth from a test set of patient cases.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as points 2 and 3.

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 not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" here is the performance and characteristics of the previous, cleared predicate device. The modified device's "truth" is established by demonstrating its equivalence to this predicate device in terms of function, safety, and effectiveness, as determined through engineering assessment against established standards and internal testing. No clinical "ground truth" from patient data is established or used in this specific regulatory submission for a device modification.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware modification for an infusion pump control unit, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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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.

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The Signature Edition® Infusion System (Models 710X and 720X) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The Signature Edition® Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission. The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products.

This document is a 510(k) premarket notification for a medical device (infusion pump), not a study report. Therefore, it does not contain information about acceptance criteria, study design, or device performance against specific metrics as requested.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a previously cleared device. It states:

• "The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission." (Page 0)
• "With the exception of the device modification presented in this submission, the Signature Edition® Infusion System is essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same." (Page 1)
• "A comparison of the technological characteristics of the Signature Edition® Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the modified Signature Edition® Infusion System is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." (Page 2)

Therefore, I cannot provide the requested information, as these details are not present in the provided text.

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The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

The subject of this 510(k) submission is the Signature Edition® Gold Infusion System, which is also known as the Alaris® SE Pump (collectively referred to herein as "SE Gold Pump"). This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003 (first submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission.

The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. Infusion pumps have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.

This document is a 510(k) premarket notification for the Cardinal Health Signature Edition® Gold Infusion System (Alaris® SE Pump). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific quantitative acceptance criteria through new clinical or performance studies.

Therefore, the provided text does not contain the information requested regarding acceptance criteria that would typically be found in a study demonstrating device performance for a novel or significantly modified device. The document explicitly states:

• "This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003"
• "With the exception of the device modification presented in this submission, the SE Gold Pumps are essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same."
• "The results of this comparison demonstrate that the modified SE Gold Pump is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered."

Since this is a substantial equivalence submission, studies with acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The "study" referenced is the comparison to the predicate device to establish substantial equivalence based on technological characteristics and intended use.

No information for the following points can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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