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The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges.
The Introducer Sheath and Dilator is used for percutaneous introduction of catheters and guide wires.

The introducer set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.

The provided text describes a 510(k) premarket notification for an "Introducer Sheath and Dilator" (K971165). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI performance are not applicable to this 510(k) submission.

Here's an breakdown of the available information:

Description of the Device and its Intended Use:

The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges. The set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the submission. 510(k)s for devices like this typically don't include a table of performance metrics and acceptance criteria in the same way a new, high-risk device might. The "performance" is implicitly deemed acceptable if it is substantially equivalent to predicate devices that are already on the market and considered safe and effective.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided. Clinical studies with test sets, as understood in the context of performance metrics and AI, were not part of this 510(k) submission. The substantial equivalence was likely based on design comparisons and perhaps bench testing, but specific sample sizes for a "test set" are not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not provided. Ground truth in the context of a 510(k) equivalence claim usually refers to the established safety and effectiveness of the predicate devices already on the market, rather than a new "ground truth" being established for the submitted device through expert review of a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a formal test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not performed or reported. This type of study is more common for diagnostic imaging AI devices, not for an introducer sheath and dilator.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study as would be conducted for an AI algorithm was not performed or reported. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of legally marketed predicate devices. The submission states: "The proposed introducer dilator has been shown to be substantially equivalent to Cook's Peel-Away® Introducers and to B. Braun's Tearaway Introducer." This means the predicate devices' historical performance and acceptance served as the benchmark.

8. Sample Size for the Training Set:

This information is not applicable/not provided. This device is not an AI algorithm, so there is no training set in that sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided for the same reason as above.

In summary: K971165 is a 510(k) premarket notification for an introducer sheath and dilator. Its "acceptance criteria" were met by demonstrating substantial equivalence to existing, legally marketed predicate devices (Cook's Peel-Away® Introducers and B. Braun's Tearaway Introducer). The submission text does not detail specific performance metrics, clinical study results, or AI-related evaluations that would typically include the requested information. The FDA's letter confirms that based on the provided information, the device was found substantially equivalent and could proceed to market.

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