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The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

The provided document is a 510(k) premarket notification for the Zenysis™ Short-Term Dialysis Catheter. It does not describe a study involving an AI/algorithmic device or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and performance testing to ensure safety and effectiveness.

Therefore, most of the information requested in your prompt (acceptance criteria tables, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI) is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the device itself from the safety and performance testing section.

Here's the relevant information that can be extracted from the provided document:

Study Type: This is a medical device substantial equivalence submission (510(k)), not a study on an AI/algorithmic medical device. It involves bench testing of the physical catheter, not evaluation of a diagnostic algorithm's performance with human readers.

Acceptance Criteria and Device Performance for Zenysis™ Short-Term Dialysis Catheter

Details from the document that are not applicable to the AI prompt but are included for context:

• Sample size used for the test set and the data provenance: Not applicable to an AI device. The testing here refers to physical product testing (bench tests) on the Zenysis™ catheter. The document does not specify the number of catheters tested for each metric, but mentions "Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI and expert consensus are not relevant here.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. This is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical medical device, "ground truth" would be established by physical measurements, material properties, and functional performance testing against established engineering and medical standards.
• The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Relevant Guidance Documents and Standards Used for Testing:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• Draft Guidance for Industry and Food and Drug Administration Staff: Implanted Blood Access Devices for Hemodialysis, June 28, 2013
• ISO 10555-1:2013, Sterile, single-use intravascular catheters – Part 1: General requirements
• ISO 10555-3:2013, Sterile, single-use intravascular catheters – Part 3: Central Venous catheters
• ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use
• ASTM F756:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F1841:1997 (R2013), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• ISO 10993-1 CORR1:2010. Biological Evaluation of Medical Devices: Part 1 - Evaluation and Testing
• ISO 14971:2012, Medical Devices - Risk Management for Medical Devices (for Risk Management/FMEA)

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