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The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.

Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.

The provided text describes a 510(k) premarket notification for the Pristine™ Hemodialysis Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study against a defined ground truth.

Therefore, many of the requested points, such as detailed acceptance criteria with reported device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not provided in this type of regulatory document.

However, based on the information given, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests passed and met the predefined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the quantitative reported performance for most of the tests. It only lists the tests performed.

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

• Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of devices or components tested for each bench or biocompatibility test.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests performed are laboratory/bench tests and biocompatibility studies, not clinical studies on human subjects. The data would be generated in a lab setting.

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

• Not applicable in the context of this document. The "ground truth" for the tests mentioned (biocompatibility, bench testing) is defined by established engineering and biological standards (e.g., ISO, ASTM). These are objective measurements against specified criteria, not subjective expert interpretations that require consensus.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the tests are objective measurements against defined standards, not subjective assessments requiring an adjudication process.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those involving human interpretation of images, to assess the impact of AI on reader performance. The Pristine Hemodialysis Catheter is a physical medical device, not a diagnostic AI system.

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

• No, a standalone performance assessment (in the context of an algorithm) was not done. This device does not involve an algorithm for performance, but rather physical and biological performance characteristics.

7. The Type of Ground Truth Used

• The "ground truth" for the performance data in this submission is based on adherence to international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for medical device performance and biocompatibility. For bench testing, this means meeting predefined engineering specifications and functional requirements. For biocompatibility, it means demonstrating that the materials are safe for biological contact as per established protocols.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set is used for this type of device submission.

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