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The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.

The Misty Finity nebulizer is a small volume nebulizer designed to deliver continuous aerosolized drugs to the respiratory system over extended periods of time. The Misty Finity is a single patient use device, and may be used for multiple treatments. The nebulizer is filled with a liquid, typically respiratory medication and connected to the air source via flexible tubing operating between 2 LPM and 4 LPM. The nebulizer is disassembled and reassembled after adding the medication in the bottom (reservoir), and then the device is reassemble in a snap fit. The Misty Finity consists of three components: nebulizer top, one-piece jet, and nebulizer bottom. The Nebulizer is marketed with oxygen tubing and an adult aerosol mask. Both tubing and mask are single-use accessories. The pediatric aerosol mask can be ordered online/from the company website.

The provide text describes a 510(k) premarket notification for the AirLife™ Misty Finity™ Nebulizer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance against specific acceptance criteria in the way an AI/ML medical device might.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this document.

However, I can extract the acceptance criteria and performance data related to the device's functional characteristics, as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by compliance with the USP 38 standard for "Products for Nebulization – Characterization Test" and a series of ISO 10993 standards for biocompatibility. The performance data presented are the results of these characterization tests.

• MMAD (Mass Median Aerodynamic Diameter):
  • Albuterol Sulfate: 3.4 ± 0.3 µm (2 lpm), 2.7 ± 0.3 µm (4 lpm)
  • Budesonide Suspension: 3.8 ± 0.3 µm (2 lpm), 4.2 ± 0.2 µm (4 lpm)
  • Cromolyn Sodium: 2.3 ± 0.3 µm (2 lpm), 3.6 ± 0.4 µm (4 lpm)
• GSD (Geometric Standard Deviation):
  • Albuterol Sulfate: 2.8 ± 0.2 (2 lpm), 2.6 ± 0.1 (4 lpm)
  • Budesonide Suspension: 3.1 ± 0.2 (2 lpm), 2.4 ± 0.2 (4 lpm)
  • Cromolyn Sodium: 3.5 ± 0.3 (2 lpm), 2.5 ± 0.1 (4 lpm)
• Particle Distribution (% mass and µg) for:
  • Particles (≤ 1 µm)
  • Particles (1-5 µm)
  • Particles (≤ 5 µm)
  • Particles (≥ 5 µm)
• Calculated Time to Deliver 100% of Dose: (e.g., Albuterol sulfate: 94 ± 12 min @ 2 lpm, 104 ± 10 min @ 4 lpm for 2.5mg/3ml concentrated solution with 4ml fill volume; and other values presented in the tables for the other drugs). |
  | Biocompatibility Testing (AAMI/ANSI/ISO 10993 series):
• Part 1: Evaluation and Testing
• Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• Part 5: Tests for In Vitro Cytotoxicity
• Part 6: Tests for local effects after implantation
• Part 10: Tests for Irritation and Skin Sensitization
• Part 11: Tests for systemic toxicity
• Part 12: Sample preparation and reference materials
• Part 17: Establishment of allowable limits for leachable substances
• Part 18: Chemical characterization of materials | The document explicitly states that "Tests for an externally communicating, tissue by way of gas path and direct mucosal contact with prolonged contact (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables" were conducted. The conclusion states that "The non-clinical data demonstrate that the Misty Finity nebulizer is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device," implying successful compliance with these standards. Specific numerical results for each biocompatibility test are not provided in this summary. |
  | Flow Rates: 2-4 LPM | 2-4 LPM |
  | Maximum Fill Capacity: 10 ml | 10 ml |
  | Shelf Life: Adequate | 11 months (supported by real-time aging and biocompatibility testing) |
  | Useful Life: Adequate | 48 hours (supported by real-time aging and biocompatibility testing) |
  | Type of Gas Source: Compressed air or oxygen | Compressed air or oxygen |

2. Sample size used for the test set and the data provenance:
Not applicable. This is a premarket notification for a medical device (nebulizer), not an AI/ML diagnostic device with a "test set" in the traditional sense. The performance data relates to the physical and functional characteristics of the nebulizer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of an AI/ML device, refers to expert labeling or definitive diagnoses. For this nebulizer, "ground truth" would be objective measurements from laboratory testing, not expert consensus on interpretations.

4. Adjudication method for the test set:
Not applicable.

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 not an AI/ML diagnostic tool intended for human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used:
For the Performance Testing (Aerosol Characterization), the ground truth is established by the standardized methods of the USP 38 using specialized laboratory equipment (7-stage Cascade Impaction - NGI) to objectively measure particle size distribution and drug delivery.
For the Biocompatibility Testing, the ground truth is established by standardized laboratory tests adhering to various AAMI/ANSI/ISO 10993 standards, employing validated biological and chemical assays.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set. The performance data is derived from physical and chemical testing of the device itself.

9. How the ground truth for the training set was established:
Not applicable.

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