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The Multi Drip™ Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an intraoperative site for postoperative pain management. Infusions may also be administered percutaneously.

The Multi Drip™ Infusion Catheter is designed to be used with the Alpha Infusion Pump (K021964) to deliver a continuous infusion of medication to a patient at a predetermined flow rate. It is a sterile, non-pyrogenic, single use device for use in the hospital or by an ambulatory patient. Except for the size of the exit ports and the closed distal end of the catheter, the Multi Drip Infusion Catheter is identical in construction and operation to the previously cleared Alpha Cath Infusion Catheter series (K021964). Like the Alpha Cath Infusion Catheter, the proximal end of the Multi Drip™ Infusion Catheter has a stainless steel needle attached to it for insertion of the catheter into the outflow septum of the Alpha Infusion Pump. The flow rate of the fluid delivered from the Alpha Infusion Pump through the catheter is determined by the preset delivery pressure of the pump and the internal diameter and length of the micro-bore PVC tubing forming the catheter. The Multi Drip™ Infusion Catheters are available in a range of lengths and flow rates identical to the Alpha Cath Infusion Catheters. Both catheter series are packaged in individual Tyvek pouches and sterilized by gamma irradiation.

The provided document is a 510(k) summary for a medical device (Multi Drip™ Infusion Catheter) seeking substantial equivalence to existing devices. It does not describe a clinical study in the typical sense (e.g., comparing human readers with and without AI assistance). Instead, it focuses on demonstrating that the new device performs equivalently to previously cleared predicate devices through engineering tests and comparisons of design and materials.

Here's a breakdown of the information requested, based on the provided text:

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

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

• Sample Size: The document states that "Multi Drip™ Infusion Catheters are 100% tested for flow rate, as are the Alpha Cath Infusion Catheters, prior to release." This implies that every manufactured unit undergoes this specific test. For the flow distribution through ports, the statement "flow was achieved through at least 4 of the 6 holes present in all catheters" suggests that the testing of flow distribution was conducted on a sufficient number of catheters to make this generalization about "all catheters," although a specific sample size for this test is not explicitly given.
• Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Advanced Infusion, Inc. The document does not specify country of origin for the data or whether it is retrospective or prospective, but it's presumed to be prospective testing of their own manufactured devices.

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

• This document describes performance testing of a medical device against engineering specifications and comparison to predicate devices, not a study involving human experts establishing ground truth for a test set in the context of diagnostic accuracy or AI performance. Therefore, this information is not applicable to this submission.

4. Adjudication method for the test set

• Given the nature of the testing described (physical and flow rate performance of a catheter), there is no mention of an adjudication method as would be used in expert consensus for diagnostic accuracy. The performance criteria are objective measurements. Therefore, this information is not applicable to this submission.

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

• A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This document describes the safety and effectiveness of a physical medical device (infusion catheter), not a diagnostic algorithm or AI system that assists human readers.

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

• This question is not applicable as the device is a physical infusion catheter, not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for the performance of the Multi Drip™ Infusion Catheter is based on engineering specifications, objective physical measurements (like outer diameter, length, breaking strength, bond strength), and functional test results (flow rate accuracy, flow distribution through ports). The comparison to predicate devices also serves as a benchmark for "equivalent performance." It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. The sample size for the training set

• This document does not describe a machine learning or AI model, thus there is no training set in this context.

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

• As there is no training set for a machine learning model, this question is not applicable.

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