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Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray. This chemical self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device is packaged in either a pharmaceutical glass bottle or steel aerosol can with several variations of nozzles. The patient contact is less than ten seconds and the skin is cooled through rapid evaporation of the non-medicated volatile propellant.

The provided text describes a 510(k) premarket notification for "Gebauer's Ethyl Chloride Topical Anesthetic Spray", asserting its substantial equivalence to a predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing new acceptance criteria or proving efficacy through clinical studies as would be done for a novel device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on demonstrating equivalence through comparison of technical characteristics and existing test data for the predicate device, along with specific testing related to labeling changes.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present in a 510(k) submission of this nature:

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

The document does not specify quantitative "acceptance criteria" in the typical sense of a clinical trial (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing the new device has the same technological characteristics and similar indications for use as the predicate device, and that specific tests for labeling changes were met.

Therefore, a table of acceptance criteria and reported device performance directly addressing efficacy is not presented. The performance is summarized by demonstrating no impact on the device's function or safety due to minor changes.

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

• Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient numbers or a large dataset. The "tests" mentioned (Biocompatibility, USP ) are laboratory-based and generally involve material samples or microbiological cultures, not human or large-scale clinical test sets.
• Data Provenance: Not specified, as these are laboratory tests rather than clinical data from a specific country or collected retrospectively/prospectively from patients.

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)

This information is not applicable to the type of device and tests described. The tests performed (Biocompatibility, USP ) are standardized laboratory tests, not subjective interpretations requiring multiple human experts to establish ground truth.

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

Not applicable. Adjudication methods are typically employed in clinical studies where multiple readers interpret results, which is not the case for the laboratory tests performed here.

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 anesthetic spray, not an AI-powered diagnostic system, thus MRMC studies, AI assistance, or human reader improvement are irrelevant to its evaluation.

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

Not applicable. This device is a medical device, not an algorithm.

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

For the tests mentioned:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and the absence of specific adverse biological reactions (cytotoxicity, sensitization, irritation) in validated test models.
• USP Antimicrobial Effectiveness Testing: Ground truth is defined by the pharmacopeial standard (USP ) which sets specific log reduction targets for microorganisms after inoculation over time.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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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