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Spire Biomedical, Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.

Device Description

The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

AI/ML Overview

Here's a summary of the acceptance criteria and the studies related to the Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Heparin Coating Bioactivity	Maintaining heparin's bioactive properties for a minimum of 90 days.	"Heparin bioactivity remained essentially constant throughout the test period, demonstrating that the coating’s bioactive properties were maintained." (90-day durability tests performed in saline, assessed at 7 regular intervals).
Thrombus Accumulation Reduction	Significant reduction in total thrombus accumulation compared to uncoated catheters.	In-vitro: "Animal and in-vitro studies have demonstrated that the coating reduces total thrombus accumulation by 94% and 96%%, respectively, compared to uncoated catheters." In-vitro (using radiolabeled measurements): "End-point thrombus radiolabeled measurements showed an average of 96% reduction in thrombus accumulation for two hours for coated catheters." Animal Study (Ovine Model): "Thrombus weight measurements... showed that the coated Decathlon catheter reduced total thrombus accumulation by 94% when compared with the uncoated Decathlon catheter in the ovine model."
Thromboresistance (In-vitro)	Improved thromboresistance as determined by: - Pressure increase in the arterial lumen - Visual evaluation of the catheters - End-point thrombus accumulation	"Results show improved thromboresistance using each of these criteria for Decathlon Coated catheters vs. uncoated catheters."
Mitigation of Specific Thrombus Types	Effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft).	"The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft)."
Mechanical/Physical/Biocompatibility	The device's small change (angle between distal end lumens) is not expected to alter the characteristics of the catheter, therefore predicate device data is acceptable.	"Mechanical, physical, and biocompatibility tests were conducted on the predicate device. These tests were not repeated for this submission since this small change (angle between distal end lumens) does not alter any of the characteristics of the catheter. Test data from the predicate device is contained in this application." (Predicate device: Spire Biomedical, Inc.'s (K060155) 15.5Fr Decathlon™ Gold Twin Lumen Hemodialysis Catheter with Separated Tips).

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 90-day durability tests (Heparin Coating Bioactivity): The sample size isn't explicitly stated for this particular part. It mentions "coated catheters" in saline, with measurements at "7 regular intervals." The study type appears to be prospective (in-vitro). No country of origin is mentioned.
- In-vitro thromboresistance study: One coated and one uncoated catheter per test. The study involved circulation of bovine blood. This is an in-vitro, prospective study. No country of origin is mentioned.
- Animal study (Ovine Model): "One coated and one uncoated catheter was evaluated in each of three animals (ovine)." This is an animal study, prospective. No country of origin is mentioned.
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)
- The document does not mention the use of human experts to establish ground truth for the performance studies. The ground truth appears to be objective laboratory measurements (heparin bioactivity, thrombus accumulation via radiolabeled measurements and weight measurements, visual evaluation, pressure increase).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as human expert adjudication is not mentioned for establishing ground truth in these performance studies.
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 MRMC comparative effectiveness study was done. This device is a medical catheter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth used for performance evaluation was based on objective laboratory measurements and animal study observations/measurements:
  - Heparin bioactivity (in pmol/cm').
  - Total thrombus accumulation (radiolabeled measurements, thrombus weight measurements).
  - Pressure increase in the arterial lumen (in-vitro).
  - Visual evaluation of catheters (in-vitro and animal study).
  - Optical and scanning electron microscopy (animal study).
The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
How the ground truth for the training set was established
- Not applicable.

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