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The Enk Fiberoptic Atomizer Set is a topical anesthesia applicator used to apply topical anesthetics to a patient's laryngo-trachea area through the working channel of the bronchoscope using oxygen flow. The sterile one-time use device is designed and intended to be used by physicians trained and experienced in flexible fiberoptic intubation techniques.

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 Enk Fiberoptic Atomizer Set consists of a pressure resistant oxygen tube and a connecting tube connected by a three-way side-arm fitting with a small flow control opening. The set also contains an introducer catheter and two 1 ml syringes.

The provided text describes a 510(k) submission for the "Enk Fiberoptic Atomizer Set" and its substantial equivalence to a predicate device, the "MADgic™ Laryngo-Tracheal Mucosal Atomization Device" (K002255). The assessment of this device is based on performance testing and similarity to the predicate, rather than clinical study results. As such, the information required for a comprehensive acceptance criteria and study description, particularly for AI/machine learning devices, is not fully present.

However, based on the Test Data section, we can infer the acceptance criteria and the type of study conducted to "prove the device meets the acceptance criteria."

Here's the breakdown of the information requested, as much as can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Performance testing, which includes tightness, air flow and tensile testing, provides reasonable assurance of safety and effectiveness for the device's intended use." This implies that the device met these performance standards. The specific quantitative values or thresholds for "tightness," "air flow," and "tensile testing" are not provided in this document.

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

• Sample Size: Not specified. The document simply states "Performance testing." It does not provide the number of units tested for tightness, airflow, or tensile strength.
• Data Provenance: Not specified. This would typically be a laboratory setting, but no country of origin or whether the tests were retrospective or prospective is mentioned.

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

• Not applicable. This device is a medical instrument and its performance is evaluated through physical and functional testing, not by expert review of patient data to establish ground truth.

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

• Not applicable. See explanation for #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

• No. This is not an AI/imaging device. The study described is performance testing of a physical medical device.

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

• Not applicable. See explanation for #5.

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

• Not applicable. For a physical device, the "ground truth" for performance testing is typically defined by engineering specifications, validated test methods, and industry standards for physical properties (e.g., specific pressure values for tightness, flow rates for airflow, force values for tensile strength).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not applicable. See explanation for #8.

Summary of Device Evaluation Approach:

The evaluation for the Enk Fiberoptic Atomizer Set is based on:

1. Performance Testing: Focusing on physical and functional attributes like tightness, airflow, and tensile strength. The explicit acceptance criteria (e.g., "must withstand X PSI" or "flow rate must be Y L/min") are not detailed but are implied to have been met.
2. Substantial Equivalence: The primary regulatory pathway is demonstrating substantial equivalence to a legally marketed predicate device (Wolfe Tory Medical MADgic™ Laryngo-Tracheal Mucosal Atomization Device, K002255) in terms of intended use, general material composition, and design features. The comparison table (in {1}) highlights specific differences and similarities, arguing that any differences do not significantly affect safety and effectiveness.

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