(90 days)
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.
The device is a simple plastic cylinder designed to fit flush over the mouthpieces of inhalers supplied by Schering (Proventil and Vanceril), Allen and Hanburys (Ventolin and Serevent), and Warrick (Albuterol). A whistle mechanism on the device is activated by the user during inspiration. The accessory device does not introduce additional space to the metered dose inhaler or interfere with the performance of the inhaler. The whistle reminds the user to sustain a slow continuous inspiration when using the metered dose inhaler.
The provided text describes the MDI Tutor, a device designed to assist metered dose inhaler users by providing an auditory whistle during correct inspiratory technique. The information available focuses on the device's function and a single performance test.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Whistle activation at a specific inspiratory flow rate to indicate correct inspiratory technique. | The threshold pressure required to evoke the whistle was determined to be 0.13 L/sec. The results of this testing confirmed the suitability of the device for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the performance testing. It simply states "Performance testing for the MDI Tutor was designed to determine the threshold pressure required to evoke the whistle (.13 L/sec)."
The data provenance is not explicitly stated but appears to be a laboratory test conducted by the device manufacturer ("MDI Tutor Inc."). It is a retrospective test to verify a design parameter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth for this specific performance test was a physical property measurement (threshold pressure/flow rate) of the device itself, not an interpretation requiring human expertise.
4. Adjudication Method for the Test Set:
Not applicable. The test described is a direct measurement of a physical parameter, not an assessment requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The provided text does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a physical accessory, not an AI system in the traditional sense of image analysis or diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone accessory. The performance test conducted ("determine the threshold pressure required to evoke the whistle") is a standalone assessment of the device's physical function. There is no "algorithm" in the context of AI being tested here.
7. The Type of Ground Truth Used:
The ground truth used for the described performance test was a physical measurement/specimen characteristic. Specifically, the flow rate (expressed as pressure threshold) at which the device's whistle mechanism activates.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical accessory, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.