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Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

The provided text describes a 510(k) summary for a medical device, the 15.5Fr Decathlon Gold, Coated Catheters with funnel tips. However, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.

The document focuses on:

• Device Description: Details about the catheter's design, material (polyurethane with Carmeda® BioActive Surface (CBAS®) coating), and the "funneled" distal tips.
• Product Claims:
  • Maintains heparin's bioactive properties for a minimum of 90 days (demonstrated in two in-vitro studies).
  • Coating reduces total thrombus accumulation by 51% compared to uncoated catheters (demonstrated in an in-vitro thromboresistance study).
• Technological Characteristics Comparison to Predicate Devices: States that the device is identical to a predicate device (K060155) in materials, dimensions, and coating, with the only difference being the funneled distal tips.
• Performance Data: Refers to in-vitro blood loop testing and catheter flow bench testing as additional tests performed specifically for this device (Decathlon Gold with funnel tips), while other tests (stability, durability, mechanical properties) were performed on the predicate device and not duplicated.
• Predicate Devices: Lists several legally marketed devices that use the same Carmeda® BioActive Surface (CBAS®) coating.

Based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI assistance, sample sizes for training/test sets, ground truth establishment, or multi-reader multi-case studies.

The "studies" mentioned are in-vitro studies demonstrating the coating's properties (bioactivity duration, thrombus reduction) and do not involve human readers, AI, or clinical outcomes that would typically have acceptance criteria in the format requested. The document does not provide a table of acceptance criteria or specific performance against such criteria.

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