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These Coaxial Dilator Sets are intended to introduce up to a 0.038 in. guidewire or catheter into the vascular system following a small gauge needle stick

The Coaxial Dilator Set (Micro-Introducer) assembly consists of an inner dilator within a slightly shorter outer sheath which is connected to the inner dilator using a spin-lock type connector. The inner and outer dilators are made from radiopaque material so they are visible under fluoroscopy. The design of the subject device, Coaxial Dilator Set (Micro-Introducer) is unchanged from the current line of Coaxial Dilators (K000737). The subject and current marketed predicate devices are identical with the exception of the addition of an optional depth marker, optional outer hub & sheath material and additional lengths.

The provided text is a 510(k) premarket notification for a medical device called the "Coaxial Dilator Set (Micro-Introducer)". This document outlines the manufacturer's claim that their new device is "substantially equivalent" to an existing, legally marketed predicate device.

It is crucial to understand that this document describes a traditional medical device (a physical dilator set) and not an AI/software-based device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and biocompatibility testing performed to demonstrate that the new physical device performs comparably to the predicate device and is safe for its intended use.

Here's an interpretation based on the provided document, but tailored to the context of a traditional medical device. Many of your requested points are irrelevant for this type of submission.

Acceptance Criteria and Device Performance for the Coaxial Dilator Set (Micro-Introducer)

Since this is a submission for a traditional medical device (Coaxial Dilator Set) and not an AI/software device, the "acceptance criteria" relate to engineering specifications, performance tests, and biocompatibility, rather than algorithmic metrics. The "study" refers to the bench tests and biocompatibility tests conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of tests conducted, implying that the device met internal Galt Medical Corp. requirements and international standards. Specific numerical acceptance criteria and reported results are not provided in this public summary. They would typically be detailed in the full submission.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated, as these are engineering and chemical tests, not clinical studies with "test sets" in the AI sense. Samples would have been specimens of the device.
• Data Provenance: The tests were conducted internally by Galt Medical Corp. ("Design testing was conducted according to protocols based on international standards and Galt Medical requirements."). This is laboratory bench testing and biocompatibility testing, not human subject data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This relates to human expert review for clinical data, which is not part of this type of submission for a physical device where "ground truth" is established by direct measurement (e.g., tensile strength, dimensions) and laboratory analysis (e.g., biocompatibility assays).

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical image or data review by multiple experts for AI ground truth establishment. For physical device testing, results are typically objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. MRMC studies are for evaluating the performance of diagnostic devices, often AI-assisted. This is a physical interventional device, not a diagnostic one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

• Bench Test Results: Direct physical measurements (e.g., force, dimensions) against engineering specifications.
• Biocompatibility Assay Results: Laboratory test outcomes (e.g., cell viability, chemical analysis) against established international standards (ISO 10993-1).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI or machine learning device. The design and manufacturing process for the physical device are based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

In summary: The provided document is a 510(k) submission for a conventional medical device. The "acceptance criteria" are implied by the list of tests performed, which confirmed the device's functional integrity, dimensions, material properties, and biocompatibility, demonstrating its substantial equivalence to a predicate device. The "study" refers to the bench and biocompatibility testing conducted in a laboratory setting.

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