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The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon ™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.

This document is a 510(k) summary for the 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter by Spire Biomedical, Inc. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device's performance was evaluated against standards and predicate device performance.

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

The document does not specify the sample sizes used for the mechanical and physical tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests were likely conducted in a laboratory setting by Spire Biomedical, Inc.

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

This information is not applicable to this submission. The "ground truth" here relates to engineering performance specifications and existing standards, not clinical diagnoses requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as it relates to clinical studies or interpretations, not the mechanical testing described.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or diagnostic algorithms where human readers are involved in interpretation. The device in question is a physical medical device (catheter), and its evaluation relies on mechanical and physical performance tests, not AI-assisted human reading.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. This device is not an AI algorithm. Its performance is evaluated through physical and mechanical testing of the device itself.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance was:

• Comparison to the performance of the predicate device (Spire Biomedical, Inc.'s Decathlon™).
• Conformance to established ISO standards for hemodialysis catheters.
  These are objective, established criteria for evaluating physical device performance.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI model, therefore, there is no "training set."

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

This information is not applicable, as there is no training set for an AI model.

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