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The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures.

The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.

The UltraEzAir® is a prescription medical device intended for application of nebulized 4% topical lidocaine solution to the oropharynx and upper airway region of patients. The subject device is an electrically driven device. The subject device is intended to be used only in an outpatient clinical facility or office for anesthetic procedures by a healthcare professional who is trained by Airkor® on its use.

The UltraEzAir® is intended to be used on adult patients, weighing at least 80 lbs. requiring topical anesthesia of oropharynx and upper airway region prior to endoscopic examination in an outpatient clinical facility or office.

The UltraEzAir® consists of a reusable Base, a single-use non-sterile Mist Assembly placed on the Base, and a single-use nonsterile Delivery Line connected to the Mist Assembly. The Delivery Line is then connected to the working channel of an Olympus or Pentax flexible nasal laryngoscope and the lidocaine mist is applied using the distal end of the attached laryngoscope to adjacent target tissue. The application process is visualized using the attached laryngoscope.

The provided text describes the 510(k) premarket notification for the UltraEzAir® (UEA1A) device, a laryngotracheal topical anesthesia applicator. It does not contain information about a study that would establish new acceptance criteria or describe a standalone algorithm performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing and comparison of technological characteristics.

Here’s a breakdown of the information as requested, largely based on what is available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table for the device's main function (topical anesthesia application) in the context of a new efficacy study. Instead, substantial equivalence is claimed based on functional and performance bench testing demonstrating the device is "as safe and effective as the predicate device" and comparison of technological characteristics.

However, the document lists some technical specifications which could be considered performance characteristics or implicitly, "acceptance criteria" against which the device was tested.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "Animal and Clinical testing were not required for a determination of substantial equivalence of the UltraEzAir®." Therefore, there was no clinical "test set" in terms of patient data. The "test set" refers to samples used for bench testing (e.g., device units for flow rate, particle size, electrical safety testing, biocompatibility testing). The document does not specify the sample sizes for these bench tests, nor their provenance as they are laboratory tests, not data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical ground truth established for a test set of patient data, as no animal or clinical testing was required for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical ground truth or human interpretation requiring an adjudication method.

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 device is a topical anesthesia applicator, not an AI-powered diagnostic or interpretive device. No MRMC study was performed.

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

Not applicable. This device is a medical instrument for drug delivery, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance aspects, the "ground truth" was established by engineering and quality assurance standards and specifications. For instance, particle size was measured, flow rates were quantified, and biocompatibility was assessed against ISO standards. The effectiveness and safety are deemed "substantially equivalent" to the predicate device, implying that the predicate's established performance serves as the benchmark or "ground truth" for general device function.

8. The sample size for the training set

Not applicable. This document is for a medical device (hardware and single-use components) and does not describe an AI or software algorithm that requires a "training set."

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

Not applicable, as no training set was used.

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