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The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via 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 Acute Hemodialysis Catheter Set/Tray is a short-term, 12 Fr, radiopaque polyurethane central venous catheter with two independent, noncommunicating lumens. Lengths of 15, 20, and 25 cm are available based on the anatomical needs of the patient.

This FDA 510(k) summary describes a medical device, a hemodialysis catheter, and its substantial equivalence to a predicate device. It does not contain information about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested.

However, I can extract the information provided about the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and frame it as if it were describing a device's performance against acceptance criteria, using the available data. It's important to note that this is an analogy and not a direct fit for explaining an AI/ML device's validation.

Here's an interpretation based on the provided text, modified to fit the requested format for a device validation, specifically focusing on the "Validation testing" mentioned.

The document describes the Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray and its validation testing, which ensures reliable design and performance. The primary change from the predicate device (K122091) is the removal of a hydrophilic coating, and the validation tests were conducted to demonstrate that this modification does not impact safety or effectiveness.

1. Acceptance Criteria and Reported Device Performance

The device underwent "Validation testing" to ensure reliable design and performance. The acceptance criteria and reported performance for specific parameters were as follows:

Study Details:

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

   • Sample Size: The document states "When tested in an animal model that simulates clinical use." It does not specify the exact number of animals used for the validation testing.
   • Data Provenance: The study was conducted retrospectively or prospectively cannot be determined from the document. The country of origin for the animal model data is not specified.

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

   • This document describes a physical medical device and its performance in an animal model, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for an AI/ML study. The evaluation likely involved veterinary or technical personnel assessing the catheter's performance based on predefined objective criteria in the animal model.

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

   • Adjudication methods like 2+1 or 3+1 are typical for human-in-the-loop or expert consensus studies for AI/ML. For a physical device animal study, the method of assessing the "adequate" or "good" rating is not detailed but would likely involve direct observation and measurement, potentially with a single or small team of trained evaluators. No specific adjudication method is mentioned.

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 study is for a physical medical device and does not involve AI assistance, human readers, or an MRMC study design.

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

   • No. This study pertains to the physical performance of a medical catheter in an animal model, not an algorithm.

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

   • The "ground truth" for this device's performance was established through direct observation and qualitative assessment ("rating scale... 'adequate' or 'good'") within an animal model simulating clinical use. This is a functional performance assessment rather than a diagnostic accuracy assessment.

8. The sample size for the training set:

   • This concept is not applicable for a physical medical device's validation testing described here. No "training set" for an algorithm is mentioned or implied. Design control activities and pre-clinical testing would have informed the device's design, but not in the sense of an algorithm training set.

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

   • Not applicable, as there is no training set for an algorithm in this context. The "ground truth" for the device's design would have been established through engineering specifications, previous predicate device performance, and clinical requirements for hemodialysis catheters.

Summary of Limitations based on the Document:

The provided text is a 510(k) summary for a physical medical device, not an AI/ML algorithm. Therefore, many of the requested details about AI/ML study design (e.g., algorithm performance, human reader studies, training sets, expert consensus for ground truth) are not present or directly applicable. The document confirms that "appropriate design control activities" and "appropriate validation test" were performed, and the device met its pre-determined acceptance criterion regarding functional performance in an animal model and biocompatibility.

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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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