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Used for controlled elective subcricoid insertion of a tracheostomy tube.

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a device used to facilitate percutaneous entry into the trachea for placement of a tracheostomy tube. A separate, sterile tracheostomy tube is also included in an optional set.

Here's the analysis of the provided text regarding the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer:

This 510(k) submission describes a device modification to an already cleared device, not a new device. Therefore, the information provided focuses on demonstrating that the modified device remains substantially equivalent to the predicate device and meets applicable design and performance requirements, rather than presenting a comprehensive study of its clinical effectiveness like one might see for a novel AI/software device.

As a result, many of the requested categories for AI/software device studies will not be present or applicable in this document.

Acceptance Criteria and Device Performance for Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K093469)

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 sizes used for the Withdrawal Force Testing and Tensile Testing. It only states that these tests were performed. There is no information regarding data provenance (e.g., country of origin, retrospective/prospective), as this typically refers to clinical data, which is not primarily assessed here for a device modification.

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

Not applicable. This device is a physical medical device. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks, often found in AI/ML medical devices. The performance evaluation here relies on engineering and mechanical testing standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among human experts when establishing a ground truth for interpretive tasks (e.g., image reading). The testing here is mechanical/physical in nature.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/software device. No MRMC study was conducted.

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

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical tests would be the established engineering specifications and performance benchmarks for medical devices of this type, likely derived from internal design requirements and industry standards. For substantial equivalence, the performance of the predicate device also acts as a reference.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm. There is no training set in the AI sense.

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

Not applicable. No training set as per AI/ML paradigms.

Summary of the Study:

The study presented in this 510(k) submission for the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a design verification study specifically addressing modifications to an already cleared device.

• Objective: To demonstrate that the modified device remains substantially equivalent to its predicate (K072148) and continues to meet applicable design and performance requirements for safety and effectiveness.
• Methods: The primary tests reported are:
  • Withdrawal Force Testing: This likely assesses the force required to remove parts of the device or the device itself from a simulated environment, ensuring it functions as intended without premature failure or unintended dislodgement.
  • Tensile Testing: This typically measures the maximum stress a material can withstand while being stretched or pulled before breaking, ensuring the structural integrity of the device components.
• Acceptance Criteria (Implicit): The tests were deemed successful because their results "provide reasonable assurance that the device is safe and effective for its intended use" and confirm the device "meets applicable design and performance requirements." This implies that the measured withdrawal forces and tensile strengths fell within pre-defined acceptable ranges, likely benchmarks from the predicate device and relevant engineering standards.
• Ground Truth: The "ground truth" for this type of evaluation is the engineering specifications, performance standards, and the known safe and effective performance of the predicate device.
• Conclusion: The testing supported the claim of substantial equivalence by verifying that the modified device's mechanical properties (withdrawal force and tensile strength) continue to meet the necessary requirements, consistent with the predicate device.

This document does not describe clinical studies, comparative trials, or expert consensus reviews, as it pertains to a physical device modification, not a diagnostic or AI-driven system.

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