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The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

The modified Engage TR Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage TR Introducer is intended to provide easy access to the vascular system, while providing convenient temporary closure of the access port during catheter exchanges. The Engage TR Introducer range in effective length is from 7cm to 25cm. The Engage TR Introducer sheaths included in the scope of this submission range in sizes from 4-6F ACT (Active Clotting Time). In addition, the Engage TR Introducer has HPC coating on the sheath and it is compatible with 0.025" guidewires. The Engage device consists of two primary components: the Hemostasis sheath assembly and the dilator. The Hemostasis sheath assembly is the vessel access device and the dilator fits inside the sheath providing support. The dilator lumen is designed to provide a close fit to appropriately sized guidewire. At the proximal end of the Hemostasis sheath is a snap-lock hub which is equipped with a Hemostasis valve and side port with approximately 8 cm of tubing attached and ending with a 3-way stopcock. Some of the Engage devices are packaged with FDA cleared devices such as guidewires and needles.

The provided text describes a 510(k) submission for a medical device, the Engage TR Introducer. This submission primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study of acceptance criteria and performance as might be expected for a novel device or significant modification requiring clinical trials.

Therefore, many of the requested points, particularly those related to a clinical study (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, training set details), are not applicable or not provided in this document. The submission explicitly states that "no additional animal or clinical data was deemed necessary" due to the scope of modifications.

Here's the breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "predetermined design performance criteria" and "verification specification criteria," implying product testing, but does not provide details on sample sizes for these tests.
• Data Provenance: Not specified. These would be laboratory/engineering test data.

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

• Not Applicable. No clinical study was performed requiring expert ground truth establishment for a test set. Design performance criteria would likely be established by engineers and product development teams.

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

• Not Applicable. No clinical study was performed requiring adjudication of a test set.

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 is a medical device (introducer sheath), not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

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

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

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

• Not Applicable / Engineering Specifications. For the functional, packaging, sterilization, biocompatibility, and shelf-life tests, the "ground truth" would be established engineering and quality control specifications and industry standards for medical devices.

8. The sample size for the training set:

• Not Applicable. No machine learning or AI training set was used. This is a physical medical device.

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

• Not Applicable. No machine learning or AI training set was used.

Summary of the Study:

The "study" described in the 510(k) summary is a series of engineering and quality assurance tests ("functional, packaging, sterilization, biocompatibility, and shelf life tests"). These tests were performed to demonstrate that the modified Engage TR Introducer meets "predetermined design performance criteria" and "verification specification criteria," thus confirming its substantial equivalence to previously cleared predicate devices. The modifications were considered minor enough that no new animal or clinical data was required by the FDA for this submission. The core of the submission relies on the "substantially equivalent" principle, where the device's technical characteristics and intended use are compared to existing, legally marketed devices.

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