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The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads.

The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This document describes the FDA 510(k) clearance for the CPS Locator 3D Plus Delivery Catheter, a medical device. Based on the provided text, the device is a percutaneous catheter used for introducing various types of catheters and pacing or defibrillator leads. The clearance is based on its substantial equivalence to a predicate device (CPS Locator 3D Delivery Catheter, K230363).

However, the provided text does not contain any information about an AI/ML-based device or any study that would typically be described with the requested criteria (e.g., sample sizes, expert adjudication, MRMC studies, ground truth establishment, training sets). The acceptance criteria mentioned are related to engineering and biological performance of a physical medical device (catheter) rather than the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on this document. The document describes a traditional medical device clearance, not an AI/ML software clearance.

**If your intention was to ask about the acceptance criteria and supporting studies for a physical medical device as described in the document, here is the information: **

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance tests conducted, implying these tests have acceptance criteria which the device met ("passed the following tests"). Specific quantitative acceptance criteria (e.g., "leak rate must be < X ml/min") and exact reported performance values are not detailed in this summary, but the general categories of testing are listed.

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample sizes for any of the performance tests. Given this is a physical medical device, the "data provenance" would refer to the characteristics of the test units themselves (e.g., manufacturing lot, material specifications) rather than typical software data provenance like country of origin or retrospective/prospective data. This information is not provided.

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

This information is not applicable or provided for a physical device clearance where performance is typically measured through engineering tests and adherence to standards, not human expert interpretation for "ground truth."

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

This information is not applicable or provided for the type of testing described (engineering performance tests).

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:

This information is not applicable or provided. The device is a physical catheter, not an AI/ML software tool that assists human readers.

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

This information is not applicable or provided. The device is a physical catheter, not an algorithm.

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

For the engineering and physical performance tests, the "ground truth" would be established by the defined specifications, engineering tolerances, and regulatory standards (e.g., ISO, ANSI/AAMI standards). For biocompatibility, it's compliance with established biological safety profiles and regulatory guidance. No "expert consensus," "pathology," or "outcomes data" is explicitly mentioned for establishing ground truth for these performance tests.

8. The sample size for the training set:

This information is not applicable or provided. The device is a physical catheter; there is no "training set" in the context of an AI/ML algorithm.

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

This information is not applicable or provided.

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