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The Cook Turbo-Flo® HD Acute Hemodialysis Catheter is intended for acute hemodialysis, apheresis and hemofiltration. It is intended for percutaneous insertion into the subclavian, jugular or femoral veins. The device is a short-term use catheter (less than 30 days).

The Cook Turbo-Flo® HD Hemodialysis Catheters are short-term, 12 Fr., hydrophilically coated, radiopaque polyurethane central venous catheters with two independent, non-communicating lumens. Lengths of 15, 20 and 25 cm are available based on the anatomical needs of the patient. Various components may be included that are associated with placement of the device.

Here's a breakdown of the requested information based on the provided document:

The provided document is a 510(k) summary for the Cook Turbo-Flo® HD Acute Hemodialysis Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information (especially points 2-9 related to AI/algorithm studies) is not applicable or not found in this type of regulatory submission.

However, I can extract the relevant information from the document that aligns with your request for device performance and the study that proves it meets criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way one might see for an AI diagnostic device. Instead, it lists various tests conducted to ensure reliable design and performance, concluding that the results support substantial equivalence to the predicate. The implicit acceptance criterion for each test is that the device performs comparably to or within acceptable limits for a hemodialysis catheter.

Study Details:

The "study" described here is a series of bench and possibly non-clinical (e.g., in vitro, animal) tests conducted on the Cook Turbo-Flo® HD Acute Hemodialysis Catheter to demonstrate its safety and effectiveness relative to a legally marketed predicate device (K993933, Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue).

• Type of Study: This is not a clinical trial or an AI algorithm performance study. It is a design verification and validation study comprised of various engineering and biological tests typical for medical device clearance via the 510(k) pathway.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided summary. These would typically be a statistical sample of devices for the bench tests.
• Data Provenance: Not specified, but generally refers to in-house laboratory testing (Cook Incorporated, USA).
• Retrospective or Prospective: These are prospective tests performed on newly manufactured devices.

3. 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. This type of information is irrelevant for bench testing of a physical medical device. Ground truth for these tests is established by objective physical and chemical measurements against design specifications and industry standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies. For physical device performance, results are typically objective measurements.

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

• No. This is not an AI device.

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

• No. This is not an AI device.

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

• The "ground truth" for the tests listed (tensile, flow rate, burst pressure, etc.) are objective physical and chemical properties and measurements against established engineering specifications, industry standards, and biocompatibility criteria.

8. The sample size for the training set

• Not Applicable. This is not an AI device. There is no "training set" in the context of this 510(k) submission.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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