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The 55cm 15.5Fr Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.

The provided text describes a 510(k) summary for the Spire Biomedical 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study to "prove" performance in the way a clinical trial would for a novel device.

The study referenced is a set of engineering and physical tests to show the device's characteristics are similar to predicate devices or meet established standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table style, nor does it provide specific numerical performance data against those criteria. Instead, it makes a general statement of compliance.

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

The document does not specify the sample size for the mechanical and physical tests performed. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). These details are typically part of internal design control documentation and test reports, not generally included in a 510(k) summary at this level of detail.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This information pertains to studies involving expert review for determining ground truth (e.g., image interpretation). The reported study is a series of mechanical and physical tests on a medical device, which would involve engineering and laboratory testing against established specifications or standards, not expert adjudication of clinical data.

4. Adjudication Method

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts in clinical studies or data labeling. The reported study involves laboratory testing of physical device properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned or implied. This type of study assesses the performance of human readers, typically with and without AI assistance, on diagnostic tasks over multiple cases. The provided text is about the substantial equivalence of a physical medical device (catheter) through mechanical and physical testing.

6. Standalone (Algorithm Only) Performance

Not Applicable. A standalone performance evaluation is relevant for AI algorithms. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance data in this context would be:

• Engineering specifications for mechanical and physical properties.
• Established ISO standards for hemodialysis catheters.
• The performance characteristics of the legally marketed predicate devices (Spire Biomedical, Inc. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061").

8. Sample Size for the Training Set

Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The study involves testing a physical product.

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

Not Applicable. As there is no training set, there is no ground truth for a training set to establish.

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