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e Med's Microfuse Membrane Infusion Catheter is a nondilatation over-the-wire device intended for the localized infusion of therapeutic solution(s) in the coronary vasculature through a microporous membrane. The catheter is intended to be coaxially tracked over a guidewire to access a subselective infusion region in the coronary vasculature. The technique, rate of administration, duration of infusion, and appropriate sizing of the membrane to the arterial diameter is determined by the operating physician. The infusion solution should be used in accordance with the manufacturer's instructions for use.

The Microfuse Membrane Infusion Catheter is a non-dilatation, over-thewire infusion device designed for localized delivery of solutions through a microporous membrane. The membrane gently "sweats" solution through its many pores. The device can accommodate a coronary guidewire.

This 510(k) submission for the Microfuse Membrane Infusion Catheter does not contain detailed acceptance criteria and study data on device performance in the way a typical medical device clinical trial report would. Instead, it relies on a declaration of "substantial equivalence" to predicate devices. Therefore, I cannot provide a table of acceptance criteria vs. reported device performance, or details about patient data, expert involvement, or MRMC studies.

Here's an analysis of what is present in the document related to device validation:

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

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

• Not Applicable. The document refers to "Functional and safety testing" but does not specify a test set in terms of patient data or clinical samples. It appears to be bench testing or in-vitro testing. There is no information about data provenance (country of origin, retrospective/prospective).

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 submission does not describe a study involving expert readers or the establishment of ground truth by experts in the context of clinical performance evaluation.

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

• Not Applicable. No adjudication method is described as there are no expert readings or clinical evaluations requiring reconciliation.

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 device is a catheter, not an AI-assisted diagnostic tool. An MRMC study would not be relevant in this context.

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

• Not Applicable. This is a physical medical device (catheter), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

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

• Not explicitly stated in detail. The document mentions "functional and safety testing" and "conformance to product specification." This suggests that the ground truth for these tests would likely be based on established engineering specifications, mechanical test standards, and potentially in-vitro performance metrics, rather than clinical outcomes or pathology from patients.

8. The sample size for the training set

• Not Applicable. This device is a physical catheter, not a machine learning algorithm that requires a training set.

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

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

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