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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. The set consists of a balloon-tipped catheter loading dilator assembly, wire guide, introducer needle, needle holder cup, 14 French dilator, gauze pads, disposable syringe, measuring tape, disposable scalpel, lubricating jelly, and a large full-body drape with clear plastic window.

This 510(k) submission describes a device modification, specifically for the "Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer." Such submissions often focus on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device, rather than conducting extensive new clinical studies to establish novel performance criteria. The document provides information on mechanical/physical testing, but not clinical performance with respect to human-in-the-loop or standalone AI performance.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or reported performance for clinical outcomes. Instead, it focuses on engineering and material-based testing to demonstrate substantial equivalence to a predicate device.

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

• Test Set Sample Size: The document does not specify sample sizes for the mechanical/physical tests (e.g., how many balloons were tested for burst). For clinical performance, no dedicated human test set data is presented as this is a substantial equivalence submission based on a device modification.
• Data Provenance: The mechanical/physical testing data would originate from Cook Incorporated's internal labs. The document does not specify country of origin for any data or whether the data is retrospective or prospective. Given the nature of a 510(k) for device modification, it's highly likely the testing was conducted internally prior to submission.

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

• Number of Experts: Not applicable. For the mechanical/physical tests, ground truth is established by engineering specifications and objective measurements (e.g., pressure at burst, force required for failure). For clinical performance, no new ground truth was established; instead, substantial equivalence to a previously cleared device (which would have had its safety and effectiveness established) is the basis.
• Qualifications of Experts: Not applicable in the context of this submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests mentioned are objective engineering tests, not subjective interpretations requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This is expected as the submission is for a device modification seeking substantial equivalence, not a new clinical claim requiring such studies. The device is a medical instrument, not an AI or imaging diagnostic tool that would typically involve MRMC studies.

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

• No, a standalone performance study was not conducted or described. This device is a physical instrument for a medical procedure, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Mechanical/Physical Testing: The ground truth is based on engineering specifications and objective measurements (e.g., pressure, force, tensile strength).
• For Clinical Effectiveness: The ground truth is established by the predicate device's prior clearance, which presumably demonstrated its safety and effectiveness for its intended use through established clinical practice, pre-market data, or other regulatory pathways. The modified device's safety and effectiveness are inferred through its substantial equivalence to this predicate.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical instrument, not an AI system. There is no concept of a "training set" in this context.

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

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

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