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The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.

Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.

The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

This document is a 510(k) summary for the submission of a Reinforced Catheter Introducer System (RCIS) by Thomas Medical Products, Inc. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

The provided document does not outline specific numerical acceptance criteria or quantitative performance metrics typically found in a study for a diagnostic AI device. Instead, it focuses on qualitative technological characteristics and claims substantial equivalence to predicate devices based on these features. The "acceptance criteria" here are implicitly the shared technological characteristics with the predicate devices.

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

This document describes a medical device (catheter introducer system), not an AI/diagnostic software. Therefore, there is no "test set" in the context of AI performance evaluation, and thus no information on sample size, data provenance, or data type for such a test set. The evaluation is based on a comparison of device features.

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. As noted above, this submission is for a physical medical device, not an AI/diagnostic software that requires expert-established ground truth.

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

Not applicable. This submission is for a physical medical device, not an AI/diagnostic software.

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 document is for a physical medical device, not an AI product. No MRMC study or comparative effectiveness study comparing human performance with and without AI assistance would be conducted for this type of submission.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

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

Not applicable. For a physical medical device like a catheter introducer, "ground truth" would relate to its physical properties, biocompatibility, sterility, and mechanical performance, which are evaluated through engineering tests, material analysis, and pre-clinical/clinical studies (though no full clinical study report is part of this 510(k) summary). The document indicates evaluation of "similar technological characteristics, and indications for use."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no AI/machine learning aspect, there is no training set and no ground truth establishment for it.

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