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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. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 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 basic 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 includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

This is a 510(k) summary for a medical device (a catheter introducer), which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against explicit acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (2-9) which are typical for SaMD studies involving machine learning or sophisticated algorithms are not directly applicable or extractable from this document. The document describes engineering and design verification testing against internal product specifications for a physical device, not "performance" in the sense of diagnostic accuracy or clinical outcomes of an AI system.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format with corresponding "reported device performance" values for a clinical or diagnostic outcome as would be common for AI/SaMD. Instead, it lists various engineering tests performed to confirm the device's physical properties and functionality. The "acceptance criteria" here are implicitly tied to meeting the design specifications and demonstrating equivalence to the predicate device. The "reported performance" is that the device "satisfies performance requirements" and "is equivalent to the predicate device."

• Resistance to Breakage | Meet specified strength and breakage resistance. | Equivalent to predicate; satisfies requirements. |
  | 0.012" Guidewire| - Fracture Test
• Flex Test
• Strength of Union: Core-to-Coil
• Strength of Union: Wire-to-Cap | Meet specified resistance to fracture, flex, and union strength. | Equivalent to predicate; satisfies requirements. |
  | Dilator | - Distal Tip Columnar Strength
• Strength of Union: Tube-to-Hub
• Insert Leak | Meet specified columnar strength, union strength, and no leaks. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – Standard Testing | - Collapse Pressure
• Distal Tip Columnar Strength
• Flow Rate
• Tensile Strength
• Priming Volume
• Burst Pressure
• Leakage Test - Liquid
• Leakage Test - Air
• Catheter Tip Movement during Power Injection | Meet specified pressures, strengths, flow rates, volumes, and leakage integrity. | Equivalent to predicate; satisfies requirements. |
  | 4 Fr IV Catheter – after Pre-Conditioning | - Visual Inspection
• Fatigue Test
• Power Injection
• Elongation
• Burst Pressure | Maintain integrity and performance after pre-conditioning, meet power injection specs. | Equivalent to predicate; satisfies requirements. |
  | Introducer System | - Axial Forces
• Fast-flash™ Evaluation
• Insertability
• Needle-Stick safety
• Particulate Test | Meet specified axial forces, fast-flash feedback, ease of insertion, needle-stick safety, and particulate limits. | Equivalent to predicate; satisfies requirements. |

Overall Conclusion: "The results of testing demonstrate that the modified POWERWAND® Safety Introducer with an Extended Dwell Catheter (4 Fr Model) is substantially equivalent to the predicate device in design, function, and indications for use."

2. Sample size used for the test set and the data provenance

The document specifies "Prospective testing conducted for the 4 Fr Model POWERWAND®" (Table 11.2) for the listed physical and performance tests. However, it does not provide specific sample sizes (e.g., number of devices tested for each parameter) for these engineering tests. It also does not mention data provenance in terms of country of origin or whether it's retrospective/prospective clinical data because this is not a clinical study, but rather engineering verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This summary relates to the clearance of a physical medical device (catheter introducer) based on engineering performance testing, not an AI/SaMD device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for these tests would be the measurement against a defined engineering specification or standard.

4. Adjudication method for the test set

Not applicable. See point 3.

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 physical medical device; no human readers or AI assistance are involved in its operation or assessment in a diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device; there is no algorithm in this context.

7. The type of ground truth used

The "ground truth" for this device's testing would be defined by engineering specifications, industry standards, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, etc.). For example, a "burst pressure" test would have an internal specification for the minimum pressure it must withstand, which serves as the ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

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