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Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO catheters.

Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO Twin Lumen Silicone Hemodialysis Catheters with Separated Tips.

Here's an analysis of the provided text regarding the Pourchez RetrO Repair Kit, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the tensile tests. It only states "A series of tensile tests were performed."
The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The study involves tensile strength testing against an ISO standard, not expert review of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable, as it is a physical device performance test against a standard, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is not applicable to
a physical device performance test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used is the minimum tensile strength required by ISO 10555-1. This is a recognized international standard for sterile intravascular catheters.

8. The 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.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study and Device Performance:

The Spire Biomedical, Inc. Pourchez RetrO Repair Kit was evaluated through a series of tensile tests. The acceptance criteria for the device's performance was its ability to meet or exceed the minimum tensile strength specified by the ISO 10555-1 standard for hemodialysis catheters. The study concluded that the repair kit's extension adapters successfully "exceed the minimum tensile strength required by ISO 10555-1," demonstrating its substantial equivalence or conformity to established standards. The exact number of units tested (sample size) for these tensile tests is not detailed in the provided K510 summary.

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