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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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The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.

The proposed device delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration of the device is placed inside an endotracheal tube for a directed spray. The device is offered in 3 configurations, all supplied with a 3 cc syringe.

Here's an analysis of the acceptance criteria and the study details for the Medicant Mucosal Atomizer, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Medicant Mucosal Atomizer

The 510(k) summary for the Medicant Mucosal Atomizer does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device (MADgic Laryngo-Tracheal Mucosal Atomization Device, K153470) by comparing key performance characteristics. The acceptance criteria can be inferred from the reported performance of the predicate device, which the new device aims to match or be similar to.

Therefore, the table below presents the performance comparisons that serve as the de facto acceptance criteria for demonstrating substantial equivalence.

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 a distinct "test set" in the context of clinical trials or AI algorithm validation. The performance data presented (e.g., total dose, particle size, plume geometry) are likely derived from laboratory bench testing focused on the physical characteristics of the device.

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for particle size).
• Data Provenance: This is not a clinical study. The data provenance is from non-clinical performance testing conducted on the device itself. Given that it's a 510(k) submission, this testing would have been conducted by the manufacturer, Medica Holdings, LLC. The country of origin for the data is not specified but is implicitly where Medica Holdings conducts its R&D and testing. This is a prospective set of tests designed to evaluate the new device against established benchmarks (the predicate).

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

This question is not applicable. The device is a medical applicator, not an AI or diagnostic device that requires expert-established ground truth from images or other complex data. The "ground truth" for its performance characteristics (e.g., particle size, dose delivery) is established through established laboratory measurement techniques and instrumentation.

4. Adjudication Method for the Test Set

This question is not applicable. As there is no "test set" requiring expert judgment or interpretation (like in imaging studies), no adjudication method was used or needed. Performance is measured objectively through physical tests.

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

No. This type of study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is compared. The Medicant Mucosal Atomizer is a physical medical device (an applicator for topical anesthetics), not a diagnostic or AI-powered system, so an MRMC study was not performed.

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

No. This question is relevant for AI algorithms. The Medicant Mucosal Atomizer is a physical device, and therefore, no "algorithm only" performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is based on objective physical measurements using scientific equipment and standardized test methods (e.g., particle size analyzers, flow meters for dose delivery). For biocompatibility, the ground truth is established by adherence to recognized standards like ISO 10993 (implied by the testing types: Cytotoxicity, Sensitization, Irritation).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is not an AI algorithm that learns from data.

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

This question is not applicable, as there is no training set for this device.

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The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.

The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MADgic™ Laryngo-Tracheal Mucosal Atomization Device:

Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device
FDA 510(k) Number: K153470
Predicate Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device (K002255)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for any of the biocompatibility or performance tests. The data provenance is not explicitly mentioned, but these are all non-clinical, bench-top tests conducted to verify product specifications and safety, likely performed internally by the manufacturer (Teleflex Medical). No human or animal data is described for these tests; they are related to material properties and device functionality.

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

This section is not applicable as the described tests are non-clinical and do not involve expert interpretation or human ground truth. They are objective measurements against defined chemical, physical, and engineering criteria.

4. Adjudication method for the test set

This section is not applicable as the described tests are objective measurements against defined criteria, not subjective assessments requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component to this device. This device is a manual, single-use medical device for topical anesthetic application.

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

This section is not applicable as the device is not an algorithm or AI-based system. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for the biocompatibility tests is established by recognized international standards (ISO 10993-1) and specific grading scales (e.g., Kligman scoring system). For performance tests, the "ground truth" is the predefined quantitative and qualitative acceptance criteria based on engineering specifications and functional requirements. For specification verification, it's conformance to established international standards (e.g., ISO 540-2, ISO 7886-1) or internal product specifications.

8. The sample size for the training set

This section is not applicable as there is no training set mentioned for this type of device.

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

This section is not applicable as there is no training set described.

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The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.

The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.

The E-Z Mister device is a topical anesthetic atomizer. The study performed to demonstrate its performance focused on particle size testing. However, the document does not include a table of acceptance criteria, the specific results of the particle size testing, or the other requested details regarding the study methodology.

Based on the provided information, I can answer some of the points:

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

• Acceptance Criteria: Not explicitly stated in the provided document. It's only mentioned that "Performance data provided in this submission consists of particle size testing." Without specific thresholds or target ranges for particle size, it's impossible to create this table.
• Reported Device Performance: Not explicitly provided in the document. The document only states that particle size testing was performed, but the results of this testing are not given.

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: Not specified for the particle size testing.
• Data Provenance: Not specified.

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 question is not applicable as the study involved particle size testing, not a clinical assessment requiring expert-established ground truth.

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

• This question is not applicable as the study involved particle size testing, not a clinical assessment requiring adjudication.

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, a multi-reader multi-case comparative effectiveness study was not done. The study was focused on the physical characteristics (particle size) of the device.

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

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system.

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

• This question is not applicable as the study involved particle size testing through laboratory measurements, not a clinical assessment requiring ground truth established by experts or pathology.

8. The sample size for the training set

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.

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

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.

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Intended for atomizing topical anesthetics to the oropharynx and upper airway regions

The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions.

The provided document is a 510(k) Premarket Notification for a "Topical Applicator" (K070596), comparing it to a predicate device, the Wolfe Tory MADgic (K002255). The acceptance criteria and supporting study are focused on demonstrating substantial equivalence, not necessarily on a novel performance claim beyond the predicate.

Here's an analysis of the acceptance criteria and the study as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a typical numerical pass/fail format for the proposed device's performance alone. Instead, it presents a comparative analysis with a predicate device to demonstrate "substantial equivalence." The implicit acceptance criterion is that the proposed device's performance parameters should be "substantially equivalent" to (i.e., not significantly different from) the predicate device.

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

• Sample Size: The document does not specify the exact sample size for the performance tests (e.g., how many applications were tested to determine total dose, residual mass, particle size, etc.). It only provides average values.
• Data Provenance: The document does not explicitly state the country of origin. Given it's a submission to the FDA, it's likely the testing was conducted in the US or in a facility compliant with US regulatory standards, but this is not directly stated. The data is retrospective in the sense that it describes tests performed on the device for the purpose of the 510(k) submission. It is not patient data.

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

• Number of Experts: This information is not applicable and not provided. The ground truth for device performance metrics (e.g., particle size, delivered dose) is established through standardized laboratory testing methods (e.g., Cascade impactor) and direct measurements, not expert review of subjective data.
• Qualifications of Experts: N/A for this type of device performance testing.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Performance testing results are objective measurements from laboratory equipment, not subjective assessments 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 done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated for its impact on reader performance. This device is a topical applicator, not an interpretive diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Technically, the performance testing described (e.g., total dose, particle size, MMAD, plume geometry) is standalone performance, as it evaluates the device's physical characteristics and output without a direct human-in-the-loop performance measurement beyond operating the device for the test. However, it's not "algorithm only" as there's no algorithm being tested in the AI sense. It's direct device performance.

7. The Type of Ground Truth Used:

• The ground truth for the performance tests relies on direct physical measurements using established laboratory techniques and equipment, such as a Cascade impactor for particle size and MMAD, and digital imaging/photographic grids for plume geometry. It's objective, quantitative data derived from the device's output.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set of data.

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

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

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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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