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The Segue ™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.

The Segue ™ Infusion Catheter is a single lumen, over-the-wire device designed to locally deliver fluids into the peripheral (non-coronary, non-cerebral) vasculature

Here's an analysis of the provided information regarding the Segue™ Infusion Catheter, specifically addressing the acceptance criteria and study details based on the given text.

It's important to note that the provided 510(k) summary (K955534) for the Segue™ Infusion Catheter focuses on pre-market notification for a Class II medical device. For such devices, particularly those that are not complex AI/ML-driven diagnostic tools, the "acceptance criteria" and "study" are typically geared towards demonstrating substantial equivalence to a predicate device and ensuring the device meets engineering specifications for safety and basic functionality, rather than clinical performance metrics often seen in AI/ML performance studies.

Therefore, many of the questions directly related to AI/ML device performance metrics (like sensitivity, specificity, AUC, sample size for test sets, ground truth establishment by experts, MRMC studies, or training set details) are not applicable or not provided in this type of 510(k) submission.

Analysis of Acceptance Criteria and Study for Segue™ Infusion Catheter

1. Table of Acceptance Criteria and 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):

• Sample Size: Not specified for the physical testing. For the animal studies, the "sample size" (number of animals) is not provided.
• Data Provenance: The physical testing is laboratory-based, likely conducted internally by the manufacturer. The animal studies were conducted to assess placement and thrombus accumulation; details on the type of animals, country of origin, or if they were retrospective or prospective are not provided. Given the nature of medical device pre-market testing, these would typically be prospective studies.

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

• Not Applicable. This device is an infusion catheter, an interventional device, not an AI/ML diagnostic tool. Its performance is assessed through engineering tests and animal studies, not through expert-labeled diagnostic data.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging, which is not relevant here. The "results were within product engineering and marketing specifications" implies internal verification processes, rather than external expert 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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

• No. This is not an AI/ML algorithm. Its "standalone" performance is measured by its physical properties and functionality.

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

• The "ground truth" for this device's acceptance is based on:
  • Engineering Specifications: Predefined numerical ranges and pass/fail criteria for physical tests (e.g., bond strength, flow rate).
  • Biocompatibility Standards: Compliance with established ISO or other regulatory standards for material biocompatibility.
  • Visual/Observational Assessment in Animal Studies: Observing successful placement and absence of adverse events like thrombus accumulation.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set."

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

• Not Applicable. This is not an AI/ML device that requires a "training set."

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