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The 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters greater than 40 cm implant length are indicated for femoral placement.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip configuration. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets.

The provided text is a 510(k) Premarket Notification for a medical device (Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip). It asserts substantial equivalence to a predicate device and includes details about its description, intended use, and regulatory classification.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for testing/training, expert involvement, or comparative effectiveness studies. The "Performance Data" section simply states that verification/validation results demonstrate substantial equivalence to the predicate device based on comparison, but offers no specific data or methodology.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about study details regarding AI or human reader improvement, as this information is not present in the provided text.

The document primarily focuses on regulatory approval and substantial equivalence with a predicate device, rather than a detailed performance study against specific acceptance criteria.

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The 14.5 Fr x 55cm Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome™) is intended for hemodialysis, apheresis, and infusion, same indications as the predicate device. The 55cm length is specifically intended for femoral placement.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter tapers to a symmetrical tip configuration. The proximal end of the catheter bifurcates into two color-coded and silicone extension sets.

The provided text describes a 510(k) Premarket Notification for a medical device, the Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter, Femoral Length, and its substantial equivalence to an existing predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, materials, physical characteristics, and performance characteristics to the existing 14.5 Fr Palindrome™ Hemodialysis Catheter, with the modification being a longer shaft length and an indication for femoral placement.

Therefore, I cannot provide the requested table and study details.

Here's what I can extract from the provided text relevant to your questions (even if it's to state the absence of information):

1. Table of Acceptance Criteria and Reported Device Performance:

• No acceptance criteria or specific performance metrics are reported in the provided text. The document states "Performance data for the femoral length 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Results of verification / validation activities) supports the conclusion that the new length device is substantially equivalent to the legally marketed device." This implies performance testing was done, but the results and criteria themselves are not detailed.

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

• Not explicitly mentioned. No sample size for a test set is provided.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). The document focuses on the regulatory submission rather than a clinical study report.

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

• Not applicable/Not mentioned. This information would typically be relevant for studies involving human interpretation (e.g., imaging studies), which is not the focus of this device's submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned as part of the submission or review for this device. The focus is on demonstrating substantial equivalence to a predicate, not improving human reader performance with AI.

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

• Not applicable. This device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Not applicable/Not mentioned in the context of a "ground truth" for a study. For this type of device, "ground truth" would relate to the physical and functional characteristics of the catheter meeting specifications, which is assumed to be covered by "verification/validation activities" but not detailed.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical catheter, not an AI model requiring a training set.

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

• Not applicable. This device is a physical medical catheter, not an AI model.

In summary, the provided document is a regulatory submission for a medical device, focusing on substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, or expert evaluations in the way one would describe for an AI/algorithm-based device.

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