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The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following principle components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device also incorporates a mechanism that provides passive needle stick safety.

The provided text describes a 510(k) premarket notification for a medical device called the POWERWAND® Safety Introducer with an Extended Dwell Catheter (3 Fr Model). This device is substantially equivalent to a predicate device and does not involve AI or algorithms, and therefore does not have acceptance criteria or a study design in the context of an AI/ML device.

However, I can extract information related to the device's performance testing to demonstrate its equivalence to the predicate device and satisfaction of product design specifications.

Here's a breakdown of the information that can be extracted, framed as device performance rather than AI acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal "acceptance criteria" table in the AI/ML sense, but it lists various performance tests conducted. For a traditional medical device, these tests are designed to demonstrate that the device meets its design specifications and is safe and effective for its intended use. The Reported Device Performance column would generally indicate that the device passed or met the requirements for each test.

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

• Test Set Sample Size: The document does not specify the exact sample sizes (N) for each individual test conducted. It generically refers to "Prospective testing conducted for the 3 Fr Model POWERWAND®."
• Data Provenance: The document does not indicate the country of origin of the data or whether it was retrospective or prospective in the clinical sense. However, the testing indicated ("Prospective testing conducted for the 3 Fr Model POWERWAND®") implies that the tests were carried out on newly manufactured 3 Fr Model devices (i.e., prospective device testing, not clinical data provenance).

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

• Not Applicable. This is a physical medical device clearance, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these performance tests is based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not an AI/ML device, there is no need for adjudication of results by multiple experts. Device performance is determined by meeting pre-defined engineering and safety specifications through objective measurements.

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

• No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers' performance is compared with and without AI assistance. This device is an introducer with a catheter; it's a tool for medical procedures, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This device does not have an algorithm or AI component. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

• Engineering Specifications and Physical Measurements. For each test (e.g., strength of union, flow rate, burst pressure), the "ground truth" is established by the documented design specifications and industry standards for medical devices of this type. The device's performance is measured against these objective criteria using calibrated equipment.

8. The Sample Size for the Training Set:

• Not Applicable. This device is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

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

• Not Applicable. Since there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant for this traditional medical device.

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