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The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.

The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or 0.038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.

The Dilator Adapter is a polyethylene bump extrusion that fits into a .035"-.038" compatible vessel dilator with an internal diameter-sized-- to an .018" guidewire.

Here's a breakdown of the acceptance criteria and study information for the Arstasis Dilator Adapter based on the provided text, formatted to address your specific questions.

Important Note: The provided text is a 510(k) summary document for a medical device. These types of documents are generally focused on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed statistical analyses often associated with AI/software performance studies. As such, information regarding AI-specific criteria (like MRMC studies, training set details, or complex ground truth establishment) is not present. The document focuses on performance testing of the physical properties and usability of the dilator adapter.

Acceptance Criteria and Reported Device Performance

Study Details

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

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 explicitly stated in the provided text for individual tests. The document refers to "the Dilator Adapter" and its "performance testing," implying sufficient samples were used for the various physical and bench tests.
   • Data Provenance: Not specified. The testing was likely conducted in a controlled lab environment. The document is for a US FDA submission, so the tests were likely performed or overseen in the USA.
   • Retrospective/Prospective: Not applicable in the traditional sense for this type of device. The testing described is a prospective evaluation of the manufactured device's physical properties and function on a bench model.

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):

   • This device is a physical medical tool, not an AI or diagnostic software. Therefore, the concept of "ground truth" established by human experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable.
   • The "ground truth" here is determined by engineering specifications, material standards (ISO11070-1998), and direct physical measurement/testing. For usability, it would involve qualified personnel performing the simulated procedures. The number and qualifications of individuals performing these tests are not detailed.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 refer to expert consensus processes for diagnostic interpretations, which is not relevant for this physical device testing. The results of the physical and mechanical tests are objective measurements against defined standards.

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 MRMC study was not done. This is a physical dilator adapter, not an AI or imaging diagnostic device where human reader performance would be a primary metric.

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

   • This is not an algorithm or AI device. "Standalone" performance as an algorithm is not applicable. The device itself is a standalone physical component designed to facilitate a medical procedure.

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

   • The "ground truth" for this device's performance testing is based on:
     • Objective Engineering Standards: Adherence to "ISO11070-1998 specifications for dilators" for tensile testing.
     • Defined Dimensional Specifications: Meeting pre-defined measurements.
     • Functional Performance Criteria: Acceptable insertion forces and overall usability as determined by bench model testing against performance expectations.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of machine learning for this physical medical device. The device's design is based on engineering principles and material science, not learned from data.

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

   • Not applicable, as there is no training set for this type of device.

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