Search Results

The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.

The FOX MOBILE is a single patient, multi-use, handheld inhalation system to deliver medications which are to be aerosolized. The system includes:

• A vibrating mesh nebulizer
• LEDs for user feedback
• . Flow limitation valve (LIMIX)
• Air control

This document is a 510(k) Summary for a medical device called "FOX MOBILE," a nebulizer system. It does not describe an AI medical device, but rather a traditional medical device for drug nebulization. Therefore, many of the requested criteria related to AI device evaluation (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and performance related to the physical characteristics and drug delivery performance of the nebulizer based on the provided text.

Here's a summary of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparative testing against the predicate device, K072019 - AKITA2 APIXNEB. The study aims to demonstrate equivalent performance to this predicate. While specific numerical "acceptance criteria" are not explicitly stated for each parameter as a pass/fail threshold, the "reported device performance" are the values obtained for FOX MOBILE and the predicate, allowing for a judgment of equivalence based on statistical confidence intervals. The document concludes that the results "demonstrated equivalent performance."

Comparative Particle Characterization (Adult Flow Rate – 15 lpm)

Comparative Particle Characterization (Pediatric Flow Rate – 12 lpm)

Other Non-Clinical Testing:

• Materials: Tested per ISO 10993-1. Results supported material requirements, including Cytotoxicity, Sensitization, Genotoxicity, Implantation, Systemic Toxicity, Subchronic toxicity, Leachable and Extractable at 50°C for 72 hours, VOC and PM2.5 with a complete Risk Based Assessment. (No specific acceptance criteria or quantitative results given in the summary, just statement that requirements were satisfied).
• Mechanical, Environmental, Simulated lifetime cycle (cleaning), Differential Pressure, IEC 60601-1 plus deviations, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 (List of tests performed, but no specific acceptance criteria or results are detailed in this summary).

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

• Sample Size: Not explicitly stated for the particle characterization tests, only "Confidence interval of 95%." For material testing, it just says "We have tested the materials."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing was presented by Vectura GmbH (Germany), so it potentially took place there or was commissioned by them.

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

• Not Applicable. This is a physical device performance study, not an AI study requiring expert ground truth for interpretation (e.g., image analysis). The ground truth here is the measured physical characteristics of the aerosol.

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

• Not Applicable. This is a physical device performance study, not an AI study involving human interpretation and 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:

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• For particle characterization: The ground truth is the measured aerosol characteristics (e.g., MMAD, GSD, emitted dose) as determined by standard laboratory methods (Cascade Impactor).
• For material testing: Industry standards and regulations (e.g., ISO 10993-1).

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set. The device is a physical nebulizer.

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

• Not Applicable. As above, no training set for a physical nebulizer.

Ask a specific question about this device