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The Arrow Diatek TM Cannon Catheter TM is indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. The Cannon Catheter™ is inserted percutaneously and is preferentially placed into the internal jugular vein. Alternately, this catheter may be inserted into subclavian vein, although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Cannon Catheter™ is intended for use in adult patients.

Device Description

The Arrow Diatek Cannon Catheter consists of a double-lumen catheter with a detached connector assembly. This allows the catheter tip to be precisely placed within the vein, similar to single lumen, dual catheters. After the catheter has been positioned, the proximal end of the catheter is tunneled retrograde to the exit site. The connector assembly is then fastened to the proximal end of the catheter using a compression sleeve and compression cap.

AI/ML Overview

The provided document for K022662 is a 510(k) summary for the Arrow Diatek™ Cannon Catheter™. This document describes a medical device and its intended use, rather than an AI/ML powered device. As such, the specific criteria requested for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or available in this submission.

The "Testing" section of the document states: "The catheter has been physically tested by both internal and outside laboratories for a wide range of criteria as well as in comparison to the predicate device. Examples include dimensional comparisons, tensile tests, pressure/flow characteristics, ISO luer conformance, ISO 10555-1 conformance, flex tests, and recirculation."

The acceptance criteria for a physical medical device like a catheter would typically involve meeting predefined specifications for these physical and performance characteristics.

Here’s a table summarizing the available information in the context of your request, while acknowledging the limitations due to the device type:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance / Evaluation	Notes on Specific Criteria
Physical Testing	The catheter undergone physical testing by both internal and external laboratories.	Specific quantitative acceptance values (e.g., "tensile strength > X N", "pressure/flow within Y-Z range") are not provided in this summary.
Dimensional Comparisons	Compared to predicate device.	No specific dimensions or comparison results are detailed.
Tensile Tests	Performed.	No specific tensile strength values or acceptance thresholds are detailed.
Pressure/Flow Characteristics	Performed.	No specific pressure/flow values or acceptance thresholds are detailed.
ISO Luer Conformance	Performed.	Indicates conformity to relevant ISO standards, but specific results are not provided.
ISO 10555-1 Conformance	Performed.	Indicates conformity to relevant ISO standards for sterile, single-use catheters, but specific results are not provided.
Flex Tests	Performed.	No specific flex test results or acceptance thresholds are detailed.
Recirculation	Performed.	No specific recirculation rates or acceptance thresholds are detailed.
Comparison to Predicate Device	Testing included comparisons to the predicate device.	The nature and outcome of these comparisons (e.g., non-inferiority, equivalence for specific metrics) are not detailed.

Regarding the other requested information (2-9):

Since this is a submission for a physical medical device (hemodialysis catheter) and not an AI/ML-powered device, the following points are not applicable or not provided in the document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for physical device testing as described. Testing would involve a number of physical units, not a "test set" of data in the AI/ML sense. Data provenance regarding "country of origin" or "retrospective/prospective" is also not relevant here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical device testing is established by engineering specifications, validated test methods, and performance against known standards, not by expert consensus on clinical data.
Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on engineering specifications, material properties, and performance standards (e.g., ISO standards) for mechanical, fluid dynamics, and biocompatibility properties.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the K022662 submission outlines the physical and performance testing conducted for the Arrow Diatek™ Cannon Catheter™, asserting its substantial equivalence to a predicate device based on these engineering-focused evaluations rather than clinical study data or AI/ML performance metrics.

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