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This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.

Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:

• Percutaneous Introducer only, or
• Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire

A description of each individual component is provided below:

Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.

18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.

Syringe
The 10ml syringe design allows for insertion into the needle.

Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.

The provided text describes a 510(k) summary for a medical device, the Teleflex Medical Percutaneous Introducer and Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device meeting specific acceptance criteria in the manner typically associated with an AI/algorithm-driven device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable as this submission pertains to a traditional medical device, not an AI medical device.

Here's the information that can be extracted and a summary of why other points are not relevant based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to performance testing with pre-determined acceptance criteria, and it met all acceptance criteria. However, it does not provide an explicit table of these criteria or specific quantitative results for each. It lists general categories of tests.

Study Proving Device Meets Acceptance Criteria:

The study consisted of "a full battery of performance testing." The document does not provide a specific name or detailed protocol for this study but indicates it was conducted by Teleflex Medical OEM.

Non-Applicable Information for this Device (as per the provided text):

Since this is a submission for a traditional medical device (percutaneous introducer kit) and not an AI/algorithm-driven device, the following points are not directly addressed or are not relevant to this type of 510(k) submission based on the provided document:

• Sample size used for the test set and the data provenance: Not applicable. Performance testing for this type of device typically involves laboratory-based tests on device samples, not patient data in the context of an AI model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
• Adjudication method for the test set: Not applicable.
• 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 is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and standards it must meet (e.g., material strength, dimension tolerances).
• The sample size for the training set: Not applicable. This device does not use an AI model that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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