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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 Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage 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 Introducer sheaths range in effective length from a nominal 12cm to a nominal 25cm. The Engage Introducer sheaths included in the scope of this submission range in sizes from 4-9F ACT (Active Clotting Time). Guidewire compatibility ranges from 0.035" to 0.038".

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 the St. Jude Medical Engage Introducer, focusing on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving a device meets specific performance metrics in the way a clinical trial or a machine learning algorithm validation study would.

This submission is for a medical device (an introducer catheter) that has undergone design modifications and asserts that these modifications do not alter its intended use or fundamental scientific technology. The review process for such a device primarily focuses on demonstrating that the modified device performs as safely and effectively as its predicate devices, rather than establishing new performance benchmarks with an AI component or complex diagnostic accuracy studies.

Therefore, many of the requested elements (like MRMC studies, standalone AI performance, ground truth for training sets, etc.) are not applicable to this type of device submission.

Here's a breakdown of the information that is available in the provided text, adapted to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that the device is "required to pass predetermined design performance criteria," but it does not list specific quantitative acceptance criteria or their corresponding reported performance values. Instead, it broadly states that the device passed various categories of tests:

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

The document states, "Based on passing verification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage Introducer, no additional animal or clinical data was deemed necessary."

This indicates that:

• Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing for this submission. The "test set" would refer to the specific units of the device subjected to the functional, packaging, sterilization, biocompatibility, and shelf life tests. The exact number of units tested for each category is not provided.
• Data Provenance: The tests are likely performed by the manufacturer (St. Jude Medical) as part of their design verification process, not from external clinical data. The data is internal to the company and would be considered prospective for these internal tests.

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

This is not applicable as the evaluation herein is not based on expert-adjudicated ground truth like in a diagnostic study. The "ground truth" for the engineering tests would be the established specifications and standards for the device's physical and functional properties.

4. Adjudication method for the test set

This is not applicable as there is no human adjudication of diagnostic outcomes or image interpretation. The "adjudication" for the engineering tests would be by technical personnel verifying compliance with specifications.

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

An MRMC study is not applicable to this device. This is a physical medical device (an introducer catheter), not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the functional, packaging, sterilization, biocompatibility, and shelf life tests, the "ground truth" is defined by predetermined design performance criteria and established industry standards for such medical devices, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable as there is no mention of an algorithm or AI system requiring a training set.

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

This is not applicable as there is no training set for an algorithm.

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