(305 days)
The efficacy of the Flutter®D as a mucus clearance device for cystic fibrosis patients is based on its ability to 1) vibrate the airways (which loosens mucus from the airway walls), 2) intermittently increase endobronchial pressure (to maintain the patency of airways during exhalation, so that mucus does not become trapped as it moves up the airways), and 3) accelerate expiratory airflow (to facilitate the upward movement of mucus through the airways so that it can be more easily coughed out). Flutter D may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for Positive Expiratory Pressure (PEP) Therapy.
The Flutter®D is a small hand held device consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high density steel ball resting in a plastic circular cone.
The Flutter®D is an expiration resisting device that delivers internal vibrations to patients' airways. The moveable ball inside the Flutter®D opposes the patient's exhaled air, creating a resistance to his expiration due to the weight of the steel ball.
The vibrations cause an oscillation effect down in the smallest airway passages within the lungs. With repeated vibrations, mucus secretions are mobilized from deep within the lungs to the throat where they can be huffed up and expectorated.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that a typical AI/ML medical device submission would. Instead, it's a 510(k) summary for a "Flutter®D Mucus Clearance Device," which is a mechanical device rather than an AI/ML algorithm.
Therefore, many of the requested categories, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable in this context. The submission relies on demonstrating substantial equivalence to a previously cleared device.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | Device does not introduce new safety concerns compared to predicate. | Not explicitly stated, but assumed to be acceptable as device cleared. |
| Effectiveness | Device is as effective as the original Flutter® in clearing mucus and facilitating PEP therapy. | "Flutter®D will be as effective as the original Flutter® in dislodging mucus from airway walls and facilitating mucus clearance and in conjunction with a medical need for positive expiratory pressure (PEP) therapy." Due to minor design and material modifications that did not significantly affect oscillation patterns. |
| Technological Characteristics | Minor modifications to design and material do not significantly affect oscillation patterns. | Modifications in design and material were minor and did not significantly affect the oscillation patterns generated by a continuous air flow. |
2. Sample size used for the test set and the data provenance
- Not applicable for a clinical test set. The submission explicitly states: "Although no clinical trials have been performed on the Flutter®D disposable device..."
- The "testing" mentioned is related to engineering analysis (e.g., oscillation patterns) of the device itself rather than clinical performance on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set with ground truth established by medical experts was performed. The substantiation is based on engineering similarity to a predicate device.
4. Adjudication method for the test set
- Not applicable. No clinical test set requiring adjudication was performed.
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 a mechanical device, not an AI/ML algorithm, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
7. The type of ground truth used
- Implied Ground Truth for Design Comparison: The "ground truth" used here is the performance characteristics (specifically oscillation patterns) of the original Flutter® device. The new device's engineering characteristics were compared to this established baseline.
- The original Flutter®'s effectiveness was established through prior clinical evidence, which informally serves as the "ground truth" for the predicate device's performance.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML algorithm with a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).