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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The current package labeling of the I-Flow Elastomeric Pump does not reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.

This document, K040337, is a 510(k) premarket notification for a labeling change to the I-Flow Elastomeric Pump. It is not a study that proves the device meets acceptance criteria for a new device, but rather a notification to market an existing device with updated labeling based on a review of existing clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a new device evaluation is inherently not present in this type of submission.

Here's an analysis of what information can be extracted or inferred from the provided text, and where the requested information is absent due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

This information is not applicable/provided in this 510(k) submission. A 510(k) for a labeling change based on existing studies does not typically define new acceptance criteria for the device itself or report new performance data. The core of this submission is to demonstrate that the proposed labeling changes (referencing specific types of surgeries and benefits) are supported by already published clinical studies where the device was used according to its previously cleared indications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/provided for a new test set in this submission. The submission refers to "published clinical studies" that support the labeling changes. Details about the sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) of these individual published studies are not provided in this 510(k) summary. These details would be found within the referenced published studies themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided for a new test set in this submission. Similar to point 2, the ground truth for the results of the referenced published studies would have been established within those studies. This 510(k) is a regulatory filing summarizing the existence and relevance of those studies, not establishing new ground truth for a new device test.

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

Not applicable/provided. As explained above, no new test set was established as part of this 510(k) filing.

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 submission is for an elastomeric infusion pump, not an AI-assisted diagnostic device or a system involving human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. This submission is for an elastomeric infusion pump, not an algorithm.

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

Not applicable/provided directly by this document for a new test set. The ground truth (e.g., pain relief, decreased narcotic use) for the results of the "published clinical studies" would be defined within those studies themselves. The submission states that the labeling changes are supported by "published clinical studies in widely known and esteemed journals," implying that the outcomes and conclusions of those studies serve as the "ground truth" to support the new claims. These outcomes likely pertained to patient-reported pain levels, narcotic consumption, or other clinical measures.

8. The sample size for the training set

Not applicable. This submission is not about an AI/ML device that requires a training set. The "training" for the device's claims comes from the clinical evidence generated in the "published clinical studies," which are not referred to as a "training set" in this context.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this device and submission. The "ground truth" for the claims in the new labeling is established by the findings and conclusions of the referenced "published clinical studies."

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