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The Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The integral catheter is intended for use in adult patients.

The Arrow integral hemodialysis catheter consists of a double lumen catheter with a molded juncture hub and two extension lines. This allows the catheter tip to be precisely positioned within the vein, similar to single lumen, dual catheters.

The provided text describes a 510(k) premarket notification for the Arrow® Integral Hemodialysis Catheter (K070260) from 2004. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with predetermined acceptance criteria.

Therefore, the document does not contain information on acceptance criteria for a clinical study or a study directly proving the device meets such criteria. Instead, it details various performance tests conducted to show equivalence to a predicate device.

Here's a breakdown of the information that is available, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

• Chemical compatibility tests
• Flow rate tests
• Biocompatibility tests
• Leak tests
• Hemolysis tests
• Tensile tests
• Flex tests
  The conclusion states: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." |

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

• Not applicable/Not provided. This submission relies on laboratory performance tests, not a clinical "test set" in the context of human data. The performance tests would have used various samples of the device itself.
• The data provenance is implicitly from internal Arrow International, Inc. laboratory testing in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not applicable/Not provided. Ground truth, in the sense of expert assessment for a clinical test set, is not relevant to the laboratory performance tests described.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. This is not a clinical study involving human readers or adjudicated outcomes.

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:

• Not applicable/Not provided. This device is a physical medical device (catheter), not an AI algorithm. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not applicable/Not provided. As stated above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For the performance tests, the "ground truth" would be established by the validated methods and specifications for each laboratory test. For example, a "flow rate test" would have a defined standard for measuring flow, and the results would be compared against the performance of the predicate device or a pre-defined engineering specification.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable/Not provided. As there is no training set.

Summary based on the document:

The 510(k) submission for the Arrow® Integral Hemodialysis Catheter primarily relies on bench testing and laboratory performance assessments to demonstrate substantial equivalence to a legally marketed predicate device (Arrow Cannon Catheter K010399). The device's performance was evaluated across chemical compatibility, flow rate, biocompatibility, leak, hemolysis, tensile, and flex tests. The report concludes that these tests demonstrate the device is "as safe and effective as the legally marketed predicate devices." No clinical studies with new acceptance criteria or human reader performance assessments are detailed in this 510(k) summary.

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