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The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

The Fountain ValveTip Infusion Catheter is intended to administer infusions of various therapeutic solutions into peripheral vasculature of a patient. The Fountain ValveTip Infusion Catheter has infusion holes at the distal end. These infusion holes allow for passage of thrombolytic fluid. The infusion segment of the catheter is indicated by two radiopaque marker bands. These marker bands can provide the user the means for positioning the infusion length at a desired location with the blood vessel.

The Fountain ValveTip Infusion Catheter uses a valve at the distal tip to seal the catheter to facilitate flow through the catheter and spray distribution through the infusion holes. The valve allows the catheter to track over a 0.035" guide wire to facilitate placement of the catheter. The Fountain ValveTip Catheter is available in 4 and 5 French including usable lengths from 45 cm to 135 cm and infusion segments length from 5cm to 50 cm. The usable length and Infusion lengths are the same as the predicate device configuration and will have same functional infusing characteristics.

This device is provided with the following Merit device which is already marketed in the US (Class II Exempt):
• AccessPLUS™ Hemostasis Valve

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fountain ValveTip Infusion Catheter, structured according to your request.

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical trial or AI model validation. As such, some of the information you requested (especially regarding AI model performance, human reader studies, and detailed ground truth adjudication for an AI device) is not present in this type of document because the device described is a physical medical catheter, not an AI/software as a medical device (SaMD).

Therefore, many sections of your request will be answered with "Not Applicable (N/A)" or "Not specified in the provided document" because the context is a physical device, not an AI system.

Device: Fountain ValveTip Infusion Catheter

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

For a physical medical device like a catheter, "acceptance criteria" and "performance" are typically related to engineering specifications and conformity to standards rather than AI model metrics. The document references various ISO and ASTM standards and internal bench testing.

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

For a physical device, "test set" refers to the physical samples tested.

• Sample Size: Not specified quantitatively for each test in the provided summary. It states "Performance testing... was conducted." Typically, engineering tests involve a sufficient number of units to demonstrate statistical confidence or meet regulatory batch release requirements, but exact numbers are not detailed here.
• Data Provenance: N/A for data provenance in the context of a dataset for an AI model. For a physical device, the "data" comes from bench tests and biocompatibility studies performed on manufactured devices.

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

N/A. This is a physical medical device (catheter), not an AI/SaMD. "Ground truth" for a physical device is established through validated laboratory tests, engineering measurements, and standardized biological assessments, not expert consensus on images or diagnostic outcomes.

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

N/A. Not applicable to physical device 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

N/A. This device is not an AI/SaMD. No MRMC study was performed or is relevant for this type of device.

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

N/A. This device is a catheter, not an algorithm.

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

For a physical medical device, "ground truth" for performance is defined by:

• Established ASTM/ISO standards: Compliance with predefined physical, mechanical, chemical, and biological properties.
• Engineering specifications: The device's design parameters (e.g., French size, usable length, valve performance) must meet internal specifications.
• Biocompatibility testing against a predicate device or historical data: Bio-reactions are assessed against known safe limits or compared to predicate device performance.

8. The sample size for the training set

N/A. There is no "training set" in the context of a physical medical device that isn't incorporating machine learning.

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

N/A. Not applicable as there is no training set for this device.

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The Squirt™ Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.

The Squirt™ is a fluid delivery system, designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature. The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given as a part of the thrombolysis treatment regimen. The catalog number for the Squirt™ is FDS100. The Squirt™ is packaged sterile, nonpyrogenic and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067.

This document is a 510(k) summary for the "Squirt™ Fluid Delivery System" from Merit Medical Systems, Inc. It details the device's description, intended use, and a comparison to predicate devices, focusing on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document concerns a 510(k) submission for a physical medical device, the "Squirt™ Fluid Delivery System," which is a fluid delivery system for thrombolytic agents. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria for a new clinical study. Therefore, a table of acceptance criteria and reported device performance, as one would see for a diagnostic AI device, is not applicable in this context.

Instead, the submission primarily relies on:

• Technological Characteristics Comparison: Showing that the materials and functional features are similar to predicate devices.
• Predicate Device Equivalence: Asserting that the device is substantially equivalent to legally marketed predicate devices, which implies it will perform similarly and safely.

The key performance aspect mentioned is "repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given." However, the document does not provide quantitative acceptance criteria (e.g., +/- 0.05 ml accuracy, X% repeatability) or specific study results for these performance metrics. The equivalence to existing devices is the primary "performance" argument.

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

• Not Applicable: This 510(k) summary does not describe a clinical study with a "test set" and "data provenance" in the way one would for an AI diagnostic algorithm. The primary "test" is an assessment of substantial equivalence to existing predicate devices. The document does not provide details of any specific performance testing on human subjects or patient data.
• The safety and effectiveness are established through comparison of design, materials, and intended use with established legally marketed devices (AngioDynamic® Pulse*Spray® Pulsed Infusion System, Merit Medical Medallion™ Syringe, Merit Medical Check Relief Valve).

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

• Not Applicable: As there is no described test set requiring ground truth establishment by experts for performance evaluation, this question does not apply.

4. Adjudication method for the test set:

• Not Applicable: As there is no described test set, no adjudication method is mentioned.

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:

• No: This is a 510(k) submission for a physical medical device (fluid delivery system), not an AI diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• No: This is for a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

• Not Applicable: Ground truth, in the context of diagnostic performance, is not discussed as this is a medical device clearance based on substantial equivalence. The "truth" here is essentially the recognized safety and performance profile of the predicate devices.

8. The sample size for the training set:

• Not Applicable: This is a 510(k) submission for a re-categorization of a physical medical device, not an AI or machine learning algorithm requiring a training set.

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

• Not Applicable: As there is no training set for an algorithm, this question does not apply.

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