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Funhaler® is intended for use primarily in the pediatric population. Pediatric subgroups may vary, however Funhaler® is suitable to all subgroups with the exception of newborns and infants younger than 18 months. Funhaler® is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

Funhaler® is primarily intended for use in the pediatric population in conjunction with prescribed Metered Dose Inhalers for their respective approved uses in accordance with physician instructions. Funhaler® is for prescription use only.

Funhaler® is only indicated for use with Metered Dose Inhalers. Other products such as Nebulizers and Actuators are not suitable for use with Funhaler®.

Funhaler® is intended to improve compliance with pediatric patients in the use of MDI's, by providing audible and visual feedback to the patient indicating the proper use of the MDI and resultant medication delivery to the patient.

The Funhaler® is basically a Spacer, similar in function and construction to commonly used Spacers such as the predicate device (Optichamber®, Respironics, Inc; K962822) and others, such as CT Spacer (K010680). The device consists of a Mouthpiece, cylindrical Spacer, tapered on each end and a molded connector compatible with approved Metered Dose Inhalers.

The Funhaler® differs from predicate device in a number of ways;

• 1. Funhaler® is provided with a breathing Mask in addition to the Mouthpiece. The breathing mask fits over the face (mouth and nose) to assure the full inhalation of the drug from the MDI in pediatric patients. Older (larger) patients may use the Mouthpiece in lieu of the Mask.
• 2. Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children.
• 3. Funhaler® incorporates a Spinner Disk, having a Mylar sticker, which spins and provides visual feedback (by spinning) when the Spacer is used properly with the MDI, also aiding in compliance with children.

The Funhaler® works in conjunction with virtually all standard, approved, Metered Dose Inhalers and has been tested for particle size, distribution and drug delivery with a variety of MDI's and drugs in accordance with FDA Guidance for these devices.

The Funhaler® is a medical device designed to improve compliance in pediatric patients using Metered Dose Inhalers (MDIs) for respiratory drug delivery. It functions similarly to a standard spacer but includes a whistle for audible feedback and a spinner disk for visual feedback, both indicating proper MDI use.

Here's an analysis of its acceptance criteria and the study proving it meets these:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Particle Size Distribution & Drug Delivery (In-vitro testing): The document doesn't specify the exact sample size (number of tests or MDIs/drugs used) but states it was tested "with a variety of MDI's and drugs." The provenance is not explicitly mentioned as retrospective or prospective, but in-vitro testing is typically prospective, performed in a controlled laboratory setting.
• Improved Compliance (Limited Clinical Testing): The document does not specify the sample size (number of children) nor the provenance (country of origin, retrospective/prospective) for this "limited clinical testing."

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

This information is not provided in the given text for either the in-vitro particle testing or the limited clinical testing. For the in-vitro testing, the "ground truth" would be objective measurements based on established analytical methods, not expert consensus. For the clinical testing, it's unclear how "improved compliance" was measured and if it involved expert assessment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests mentioned (in-vitro measurements and unspecified clinical assessment of compliance), a formal adjudication method like "2+1" or "3+1" is unlikely to be applicable in the traditional sense of diagnostic imaging studies.

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 explicitly described. The text mentions "Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device," which suggests some form of comparison, but it does not fit the typical format or description of an MRMC study comparing human readers with and without AI assistance. The Funhaler® is a physical device, not an AI or diagnostic tool.

Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

This concept is not applicable to the Funhaler® device. The Funhaler® is a physical medical device (a spacer) that enhances the delivery and perceived compliance of an MDI, rather than an algorithm or AI system. Its performance is always in conjunction with a human (the patient using it).

7. The Type of Ground Truth Used

• Particle Size Distribution & Drug Delivery: The ground truth used would be objective, analytical measurements obtained through standard, validated in-vitro testing methodologies specified by FDA guidance. This is not expert consensus, pathology, or outcomes data in the usual clinical sense.
• Improved Compliance (Limited Clinical Testing): The type of ground truth for "improved compliance" is not specified. It could involve observational data, patient/parent self-reporting, or specific behavioral metrics, but the document does not elaborate.

8. The Sample Size for the Training Set

This information is not applicable as the Funhaler® is a physical medical device, not a machine learning or AI model that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for this type of device.

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