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The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (

Here's a breakdown of the acceptance criteria and study information for the "Stiletto Extended Dwell Catheter" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details bench testing and biocompatibility testing. It does not describe a clinical test set in the traditional sense of patient data.

• Bench Testing: The specific sample sizes for each bench test are not provided in the document. The provenance is implied to be laboratory testing of the device itself.
• Biocompatibility Testing: The sample sizes for these tests are not explicitly stated, but they would typically involve material samples of the device components. The provenance is implied to be laboratory testing in accordance with ISO 10993 standards.

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

Not applicable. The study relies on objective bench test measurements and established biological safety protocols, not subjective expert assessment of a test set in the context of diagnostic or interpretive performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described as the performance is based on objective measurements against standards.

5. 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

Not applicable. This is a medical device (catheter) and the provided documentation focuses on its physical and biological performance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

Not applicable. This document is about a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• International Standards: Adherence to various ISO and ASTM standards (e.g., ISO 10555-1, ISO 10555-5, ISO 9626, ISO 7864, ISO 80369, ASTM F640, ANSI/AAMI HE75, ISO 23908).
• FDA Guidance Documents: Compliance with specific FDA guidance.
• Internal Requirements: Company-defined performance specifications.
• Biocompatibility Standards: Adherence to ISO 10993 series and USP for particulate matter.
• Predicate Device Comparison: Performance is often benchmarked against the "PowerGlide Pro™ Midline Catheter" (K162377) to demonstrate substantial equivalence, particularly in terms of flow rates and other functional characteristics.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

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

Not applicable, as there is no training set involved. The evaluation is based on direct physical and biological testing of the device itself.

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