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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 VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.

The proposed device is the identical VibraPEP™ cleared under K153441 but with a Valved T-adapter and mouthpiece that allow the user to connect a general purpose jet nebulizer.

The VibraPEP™ is an Oscillatory PEP (OPEP) device that looks like a curved shaped pipe with a plastic mouthpiece at one end. A long hose is attached inside. As the patient blows through the VibraPEP™, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect with pressure during the exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to achieve optimal therapy for each patient. The VibraPEP™ facilitates mucus clearing by generating and delivering an oscillation effect that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.

This document is a 510(k) Summary for the VibraPEP™ Mucus Clearing Device, detailing its substantial equivalence to previously cleared devices. It primarily focuses on the device's physical and functional characteristics, and its performance in comparison to predicate devices, particularly regarding its use with a nebulizer.

However, the provided text does not contain information typically found in acceptance criteria or study designs for performance of an AI/ML device. This document describes a medical device (a mechanical positive expiratory pressure device), not an AI/ML algorithm. Therefore, many of the requested elements regarding AI/ML device performance (e.g., sample size for AI test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable or present in this document.

I will attempt to answer the questions based on the information available, noting when the information is not present or not applicable to this type of device.

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

The document frames "performance" in terms of physical characteristics (pressure, amplitude, flow, frequency) and how these are maintained when new accessories are added, rather than acceptance criteria for an AI model's output metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion is implicitly that the device's performance characteristics are "not significantly changed" or "no differences" compared to the predicate devices, ensuring functional equivalence.

• Ave. Pressure (cmH2O): 9-13 (10lpm), 18-21 (20lpm), 29-40 (40lpm). Compared favorably to VibraPEP™ without T-adapter (10-13, 18-21, 27-41) and Predicate RC-Cornet (10-15, 19-22, 30-41).
• Ave. Pressure Amplitude (cmH2O): 5-13 (10lpm), 19-24 (20lpm), 46-58 (40lpm). Compared favorably to VibraPEP™ without T-adapter (7-17, 22-28, 51-76) and Predicate RC-Cornet (5-18, 20-26, 50-60).
• Frequency (Hz): 8-15 (10lpm), 16-17 (20lpm), 18-21 (40lpm). Compared favorably to VibraPEP™ without T-adapter (8-15, 16-17, 17-21) and Predicate RC-Cornet (9-16, 17-21, 17-21).
• Ave. Flow Rate (lpm): 10 (10lpm), 20 (20lpm), 40 (40lpm). Consistent with expected values. Conclusion: "Results show that there no differences between performance." |
  | Nebulizer Performance | Performance (MMAD, GSD, Total Dose, Respirable Dose, Particle distributions) of general purpose jet nebulizers should not be statistically significant altered when connected to VibraPEP™. | For Westmed - VixOne and Hudson RCI MicroMist (with Albuterol, Cromoly Sodium, Ipratropium Bromide):
• MMAD (um): Varied slightly (e.g., VixOne Albuterol: 1.7 standalone vs. 1.37 with VibraPEP).
• GSD: Varied slightly (e.g., VixOne Albuterol: 2.24 standalone vs. 2.21 with VibraPEP).
• Total Dose (ug): Varied (e.g., VixOne Albuterol: 1256 standalone vs. 1050 with VibraPEP).
• Total Respirable Dose (0.5-5): Varied (e.g., VixOne Albuterol: 896 standalone vs. 790 with VibraPEP).
• Coarse Particle (>4.7): Varied.
• **Fine particle (

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The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.

Patient - Patients who have been prescribed PEP therapy

Environment - Hospital, clinics, physician offices, home setting

The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.

The device is comprised of several components:

• Curved tube
• Cap for end of Tube ●
• Mouthpiece with selector ●
• Valve tube
• Drying tool ●

The provided text describes the 510(k) summary for the VibraPEP™ device, which is an incentive spirometer. This document focuses on demonstrating substantial equivalence to a predicate device (Pari – RC-Cornet – K983308) rather than presenting a standalone study with defined acceptance criteria for a novel AI/device performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context, as this is a traditional medical device submission based on substantial equivalence to an existing device, not an AI or imaging device requiring extensive performance studies against clinical ground truth.

However, based on the provided text, I can infer the acceptance criteria by comparing the proposed device's performance to the predicate device, as this is the basis for demonstrating substantial equivalence. The "study" proving acceptance is the "Comparative Bench Testing".

Here's the information extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The acceptance criteria are implicitly met if the proposed device's performance falls within or is sufficiently similar to the predicate device's performance ranges, demonstrating "functional equivalence." The document states: "The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet."

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a "sample size" in the context of patients or discrete cases. The testing was comparative bench testing, implying a certain number of devices were tested and measurements taken over various flow rates. The text notes "a number of performance tests" were done.
• Data Provenance: Not applicable in the traditional sense of human data. This was bench testing performed by the manufacturer, Medica Holdings, LLC.

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

• Not applicable. This was bench testing of a physical device's mechanical performance (pressure, flow rate, amplitude). There was no "ground truth" established by human experts in the way it would be for an AI diagnostic algorithm. The "ground truth" would be the measured physical properties of the predicate device under controlled conditions.

4. Adjudication Method for the Test Set

• Not applicable. This was bench testing against a predicate device's measured performance. There was no human expert adjudication of results.

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 a physical medical device (incentive spirometer), not an AI diagnostic tool involving human readers.

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

• No. This is a physical medical device. There is no "algorithm" in the context of AI independent of human use here. The performance described is the standalone performance of the physical device itself.

7. The Type of Ground Truth Used

• The "ground truth" for comparison was the measured performance data (average pressure, average pressure amplitude, average flow rate, material composition, cleaning validation, age testing, mechanical/drop test results) of the predicate device (Pari – RC-Cornet – K983308) under controlled bench test conditions.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, no training set was used.

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