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The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.

Baxter's Multirate Infusor devices with attached PCM, are single-use disposable infusion pumps designed to deliver solution at a constant flow rate of 1-12mL/hr, depending upon the device configuration and settings, as well as allow for intermittent bolus doses of medication on patient demand.

The provided text describes a 510(k) notification for a device modification of the Baxter Healthcare Corporation Multirate Infusor with PCM. The focus of the submission is to demonstrate substantial equivalence to previously cleared devices, primarily through risk analysis and design verification testing.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification tests based on the result of risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate."

However, the specific acceptance criteria (e.g., flow rate accuracy, bolus volume precision, mechanical integrity) and the reported device performance values are not explicitly detailed in the provided text. The submission focuses on the process of verifying the modifications rather than presenting quantitative performance data.

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

The document mentions "design verification tests" were performed, but it does not specify the sample size used for these tests.

Regarding data provenance: The tests were conducted internally by Baxter Healthcare Corporation to verify the design modifications. The country of origin of the data is implicitly the United States, as Baxter Healthcare Corporation is a US-based company and the submission is to the FDA. The tests are prospective in nature, as they were performed specifically to verify the recent design modifications.

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

The concept of "experts" to establish ground truth is typically relevant for diagnostic devices that interpret signals or images. This document describes a modification to an infusion pump, which is a functional medical device. Therefore, the "ground truth" here would be objective engineering measurements and functional performance against specifications.

The document does not mention the use of external experts for establishing ground truth in this context. The verification would have been conducted by Baxter's internal engineering and quality teams.

4. Adjudication method for the test set

Given that the "ground truth" involves objective engineering measurements of device performance, an adjudication method (like 2+1 or 3+1 consensus commonly used in image analysis) is not applicable or mentioned in this context. Device performance is typically evaluated against defined engineering specifications and tolerances.

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 comparative effectiveness study is not applicable here. This type of study is used for medical devices, particularly diagnostic aids that involve human interpretation (readers) of cases. The Multirate Infusor with PCM is an infusion pump, a therapeutic device, and does not involve "readers" in the context of diagnostic interpretation.

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

This question is not applicable to this device. An infusion pump does not contain an "algorithm only" component or involve human-in-the-loop performance in the way a diagnostic AI would. Its performance is inherent to its mechanical and electronic design.

7. The type of ground truth used

The ground truth for this device's performance would be established through:

• Engineering Specifications: Pre-defined functional requirements and tolerances for flow rates, bolus volumes, safety mechanisms, material compatibility, and structural integrity.
• Measurement Standards: Adherence to recognized industry standards for device performance and safety (e.g., ISO, ASTM, or internal Baxter standards derived from such).
• Risk Analysis (FMEA): The document explicitly states that Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications. This process identifies potential failure modes and their effects, leading to verification tests designed to ensure these failures do not occur within acceptable limits.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train machine learning algorithms. The Multirate Infusor with PCM is a hardware medical device; its design and verification do not involve machine learning.

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

This question is not applicable for the same reasons as #8.

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