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The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain management. Routes of administration include intravenous, subcutaneous and epidural.

The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural.

The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management.

The indications for use include hospital, alternate care, ambulatory and home environments.

The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow generated by the pressurized bladder. The pre-attached administration set may incorporate any of the following components:
• Y-tubing for multi-site delivery (single or dual)
• Air and particulate eliminating filter
• Flow Restrictor
• Luer Connector

The pump may be sold as a kit with additional devices or accessories such as the following: catheter, introducer needle, syringe, and E-clip.

This is a 510(k) summary for a medical device called the I-Flow Elastomeric Pump, which is used for infusion of medications. The document describes the device, its intended use, and compares it to predicate devices. It also states that "All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria, thereby demonstrating substantial equivalence to the predicate devices."

However, this document does not provide specific acceptance criteria or detailed study results. It only mentions that testing was conducted and met the acceptance criteria. It also mentions a simulated use study for human factors but doesn't provide details on its results in terms of concrete performance metrics.

Therefore,Based on the provided text, I cannot extract the detailed information requested regarding the acceptance criteria and study proving the device meets those criteria. The document states that testing was performed and met acceptance criteria, but it does not specify what those criteria are or present the results of the studies in a quantifiable manner.

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document states: "All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria," but it does not specify what those design requirements or acceptance criteria were (e.g., a specific percentage for flow rate accuracy). It also does not report the actual device performance numbers for these tests.

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

• Cannot be provided. The document mentions "non-clinical data and tests" and a "simulated use study of human factors," but it does not disclose the sample sizes for these tests or the data provenance.

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)

• Not applicable / Cannot be provided. This device is an elastomeric infusion pump, not an AI/imaging device requiring expert ground truth for interpretation. The document does not mention any expert review or ground truth establishment in this context.

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

• Not applicable / Cannot be provided. Similar to point 3, this is not relevant for a physical medical device's performance testing described here.

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 is not an AI-assisted device.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. For a physical device like an infusion pump, "ground truth" would relate to its physical performance metrics (e.g., actual flow rate against specified flow rate), not diagnostic interpretation. The document doesn't detail how these performance metrics were verified beyond stating they "met the design requirements and acceptance criteria."

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary asserts that the device underwent various non-clinical tests (flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) and a human factors study, and that these met the design requirements and acceptance criteria. However, it does not provide the specific numerical acceptance criteria or the actual performance results from these tests. It acts as a summary rather than a detailed report of the testing.

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