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The 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.

The 14.5 Fr Chronic Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The tip of the Maxid catheter is staggered, while the Palindrome is symmetrical. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The insertion stylets are polyethylene, and extend the full length of the catheter and protrude from the tip. The purpose of the insertion stylet is to provide the clinician with an additional option for catheter placement.

The provided text describes a 510(k) Premarket Notification for a 14.5 Fr Chronic Hemodialysis Catheter with insertion stylets. However, it does not contain the specific acceptance criteria or a detailed study section with quantitative performance data that would allow for the direct completion of all requested fields.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters) based on "intended use, materials, physical characteristics, and performance characteristics." The key modification is the addition of insertion stylets.

Here's an attempt to answer the questions based on the available information, with explicit notes where information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance

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 for test set: Not specified. The document refers to "verification / validation" but does not detail the nature or sample size of these tests.
• Data provenance: Not specified.

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/Not specified. This is a medical device submission focused on physical and performance characteristics, not an AI or diagnostic imaging study that typically relies on expert-established ground truth.

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

• Not applicable/Not specified. This is a medical device submission focused on physical and performance characteristics.

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-assisted diagnostic imaging device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" or basis for acceptance in this context is the comparison to the existing predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters) in terms of their established performance and materials. The document states "Performance data for the insertion stylets...is compared to the design requirements of the predicate devices."

8. The sample size for the training set

• Not applicable. This is a medical device, not a machine learning model.

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

• Not applicable. This is a medical device, not a machine learning model.

Summary of the Study (Based on Provided Text):

The study referenced is a "verification / validation" process comparing the performance data of the new 14.5 Fr Chronic Hemodialysis Catheter with insertion stylets against the design requirements of the existing predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters). The intent was to demonstrate substantial equivalence in terms of intended use, materials, physical characteristics, and performance. The document explicitly states that the results "demonstrate that the new catheter/insertion stylet configuration is substantially equivalent to the legally marketed device." No specific quantitative data, sample sizes for testing, or details of the "verification / validation" methodologies are provided in this summary.

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