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The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system. The Valved Tearaway Introducer Generation II is designed to reduce blood loss and the risk of air intake but it is not a hemostasis valve. It is not intended to create a complete two way seal nor is it intended for arterial use.

The Medcomp Valved Tearaway Introducer is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Valved Tearaway Introducer consists of a peel-able introducer sheath which contains a "duckbill" seal to substantially minimize air/blood from entering or escaping when the dilator is removed. The dilator is comprised of a cylindrical tube with a locking hub; the sheath is also a cylindrical tube with a hub and valve. When the dilator is fully seated it snaps into the hub of the introducer sheath to prevent independent movement of either piece when in use. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The sheath and dilator when used in conjunction with an introducer needle and quidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheath's hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of Nylon-based Triax with Barium Sulfate for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.

The provided text describes a medical device submission (K124046) for a "Valved Tearaway Introducer Generation II." This submission is a Traditional 510(k), which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

The acceptance criteria and the study proving the device meets them are based on bench testing and biocompatibility testing, and a comparison to a predicate device. This is typical for a 510(k) submission for this type of device, which is not an AI/ML powered device. Therefore, many of the requested categories (like sample size for test sets, data provenance, number/qualification of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, or training set details) are not applicable to this type of medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "the proposed device exceeds all the testing criteria the predicate device was tested against" and "has comparable or improved results for many of the performance tests." However, explicit numerical acceptance criteria and specific performance results are not provided in the summary. The summary lists the types of tests conducted.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the summary. For bench testing of physical devices, the "sample size" would refer to the number of devices or components tested, which is not detailed here.
• Data Provenance: The studies are described as "Bench Testing" and "Biocompatibility Testing," implying laboratory-controlled experiments. There is no indication of human subject data, retrospective, or prospective studies involving patients.

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

• Not Applicable. This is a physical device, and the "ground truth" for its performance is established through standardized engineering and materials testing protocols, not expert clinical consensus on images or patient data.

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

• Not Applicable. As per point 3, there's no expert adjudication involved in bench testing of physical device characteristics.

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:

• Not Applicable. This device is a physical medical instrument, not an AI/ML-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

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

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

• Standardized Bench Test Measurements / ISO 10993 Compliance: For the performance tests (Air Leakage, Dilator Insertion/Extraction, Force at Break, Liquid Leakage), the "ground truth" is defined by the objective measurements obtained from the specified test protocols and compared against the performance of the predicate device (and implicit or explicit engineering specifications). For biocompatibility, the ground truth refers to adherence to the requirements of the ISO 10993 standard.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. As per point 8, there is no training set.

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