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The FOUNTAINTM Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient

This device is a 4 French infusion catheter and system.

The provided text describes a 510(k) premarket notification for the FOUNTAIN Infusion Catheter and Occluding Guide Wire. This is a notification of substantial equivalence to a predicate device, not a study that establishes acceptance criteria through new performance data. Therefore, many of the requested details about acceptance criteria, full device performance, and study methodology are not present in the provided document.

However, I can extract the information that is available and clarify what is missing.

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

Missing Information: Specific quantitative acceptance criteria (e.g., burst pressure, flow rates, etc.) are not provided in this document. The document primarily states that testing was performed and the device was found acceptable or comparable to the predicate.

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

• Sample Size: Not specified for functional or biocompatibility testing.
• Data Provenance: Not specified. The context is a 510(k) submission to the FDA (USA).
• Retrospective/Prospective: Not specified. The functional and biocompatibility tests would typically be laboratory (in-vitro) studies.

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: This type of information is generally relevant for AI/software device studies or clinical studies involving expert interpretation, which is not the nature of this 510(k) premarket notification. The tests described are functional and biocompatibility tests.

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

• Not Applicable: Adjudication methods are typically used in clinical studies or studies where expert consensus is needed to establish ground truth from ambiguous data. The testing described (functional, biocompatibility) does not involve this kind of adjudication.

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: An MRMC comparative effectiveness study was not done. This is a conventional medical device, not an AI/software device. The document explicitly states: "Clinical testing was not performed on the subject catheter due to the similarities to the predicate device."

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

• No: This is a physical medical device (catheter and guide wire), not an algorithm or AI. Standalone performance for an algorithm is not applicable.

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

• Functional Testing: The "ground truth" for functional testing would be the pre-defined engineering specifications and performance benchmarks (e.g., material strength, flow rates).
• Biocompatibility Testing: The "ground truth" for biocompatibility is established by the methods and endpoints defined in international standards (ISO 10993-1) and FDA guidance (G95-1) for evaluating biological responses to medical device materials.
• No Clinical Ground Truth: As clinical testing was not performed, there is no clinical outcomes data, pathology, or expert consensus on clinical findings.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."

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

• Not Applicable: (See point 8).

Summary of Device and Study presented in the 510(k) document:

The 510(k) document describes the FOUNTAIN Infusion Catheter and Occluding Guide Wire. The submission aimed to demonstrate substantial equivalence to a predicate device (5 French FOUNTAINTM Infusion Catheter Occluding Guide Wire, K974067, and K991619 Fountain Infusion System).

The primary "study" cited to support this equivalence is:

• Functional testing (In-vitro): Performed to evaluate the device's integrity and performance. The document states that based on these results, the device was deemed "safe and effective and is acceptable in design and construction for its intended use." Specific details on the nature or results of this testing are not provided beyond this general statement.
• Biocompatibility testing: Performed on the predicate 5 French Fountain Infusion Catheter according to ISO 10993-1-1994 and FDA G95-1. The conclusion was that the device was "biocompatible, nontoxic and acceptable for its intended use." Crucially, the 4 French catheter (the subject of this 510(k)) was not independently tested for biocompatibility but was deemed biocompatible because it is "manufactured from the same materials as the predicate device."
• Clinical Testing: No clinical testing was performed for this 510(k) submission, relying instead on the similarities to the predicate device.

In essence, this 510(k) relies on a demonstration of technological equivalence and material equivalence to a previously cleared predicate device, supported by in-vitro functional testing and leveraging the predicate's biocompatibility data due to shared materials. It does not present new, extensive clinical study data or involve AI/software performance evaluation.

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