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The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets.

The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities

The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with optional accessories. The optional accessories are identified as follows:

• Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
• Agilia Duo - two-channel accessory designed to power two Agilia infusion pumps.
• Agilia USB Cable - intended to connect the Agilia SP infusion pump to a PC for serial communication.

The provided document describes the FDA 510(k) clearance for the Agilia SP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic or clinical outcomes.

Therefore, many of the requested detailed points regarding acceptance criteria and performance against a test set (especially those related to AI/MRMC studies, ground truth establishment, and expert adjudication) are not applicable directly to this type of device clearance and the information provided in this document.

However, I can extract information related to the acceptance criteria for the non-clinical performance of the infusion pump and the methods used to prove that performance.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating equivalence in technical specifications and safety/performance characteristics. The most direct mention of a performance criterion is for flow rate accuracy.

Note: The document states "Detailed flow rate accuracy disclosed in the labeling." This implies the acceptance criteria for the subject device are met by its reported performance of ±3% under most conditions, which is presented as being "similar" to the predicate, with the subject device apparently exceeding the predicate's reported accuracy.

2. Sample size used for the test set and the data provenance

The document specifies non-clinical testing for product requirements, human factors, and reliability. It mentions "Design verification and validation testing" and "Device reliability activities, testing and statistical analysis."

• Sample Size: The specific sample sizes for these non-clinical tests (e.g., number of pumps tested for flow rate accuracy, number of reliability tests) are not detailed in this summary document.
• Data Provenance: The tests are described as "non-clinical testing" and performed by the manufacturer (Fresenius Kabi AG, Germany/USA). This indicates they were prospective, laboratory-based tests conducted by the company for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device clearance. Infusion pumps are mechanical/electronic devices, and their performance is evaluated against engineering specifications, not human expert interpretation of data like in an AI/imaging device. The "ground truth" for flow rate, for example, is established by precise measurement equipment and engineering standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions (e.g., in radiology studies). This documentation describes non-clinical engineering and performance testing.

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

This question is not applicable. The Agilia SP Infusion System is an infusion pump, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study is irrelevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. There is no "algorithm" in the sense of an AI or diagnostic algorithm being evaluated for standalone performance. The device's "standalone" performance refers to its functional operation as an infusion pump, which was verified through non-clinical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-clinical performance (e.g., flow rate accuracy, alarms, mechanical sensors, electrical safety), the "ground truth" is established by:

• Engineering Specifications and Standards: Compliance with recognized standards such as AAMI TIR 101 2021 (for flow rate and bolus accuracy), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8 (for electrical safety and EMC), and IEC 62366-1 (for human factors/usability).
• Design Inputs and User Needs: The device was tested to confirm it "met user needs and design inputs."
• Risk Analysis: Residual risks were determined to be acceptably low using "industry-standard risk analysis practices."

8. The sample size for the training set

This question is not applicable. As a physical infusion pump (not an AI/machine learning device), there is no "training set." The device is designed, manufactured, and verified/validated against engineering principles and standards, not trained on data.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this device.

Summary of what the document does describe regarding proving device performance:

The document outlines a comprehensive set of non-clinical tests performed to demonstrate the safety and effectiveness of the Agilia SP Infusion System and its substantial equivalence to the predicate device (Alaris System with Guardrails Suite MX). These tests primarily involved:

• Verification testing of product requirements: Ensuring the device meets its specified design inputs.
• Human factors engineering testing: Evaluating the user interface and safety for critical tasks according to IEC 62366-1.
• Reliability testing: Confirming the device meets its reliability goals over its expected lifetime.
• Flow rate and bolus accuracy testing: Conducted following AAMI TIR 101 2021.
• Software verification and validation: Per FDA guidance (May 2005).
• Electrical Safety (IEC 60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) testing.
• Cybersecurity testing: Adhering to FDA Cybersecurity Guidance (October 2014, December 2016).

The "acceptance criteria" for these tests are implicitly that the device performs according to its design specifications, meets relevant international standards (e.g., IEC, AAMI), and demonstrates safety and effectiveness comparable to the predicate device (or better, as seen with flow rate accuracy). The safety assurance case framework provides an overarching structure for these demonstrations.

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