(98 days)
The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy by providing a convenient method of external thorax manipulation.
It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma. muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.
The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 100 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits.
Here's a breakdown of the acceptance criteria and study information for the Dymedso Frequencer™ Powered Percussor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Efficacy (comparable to Conventional Chest Physiotherapy) | Expelled sputum per session: 9.24 ± 1.62 g for Frequencer™ vs. 9.27 ± 1.62 g for CCPT. (Comparable quantities) |
| Safety (gentler, less painful) | "This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping." (Subjective claim, not quantified) |
| Intended Use (matching predicate devices) | "The proposed Frequencer™ has the identical indications and intended use as well as comparable technological characteristics as the predicate devices." (Claim of identical/comparable) |
| Operating Principle (differs from predicate but effective) | Uses sound wave pulses from a transducer instead of mechanical percussion, airflow-induced pulses, or pneumatically created oscillations. (Primary technological difference) |
| Force applied to chest | 0.4 - 3 N (0.090 - 0.674 Ib) - much smaller than CCPT (58.10 +/- 15.32 N) |
| Frequency range | 20-100 Hz - broader range than CCPT (6.6 Hz) and pneumatic vests/mechanical percussors (5-25 Hz) |
Study Information:
The document describes one clinical trial to assess the efficacy of the Frequencer™ compared to Conventional Chest Physiotherapy (CCPT).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 20 adult patients
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address in Quebec, Canada, and the FDA submission, it's likely the study was conducted in Canada or the US, but this is not confirmed. The study was a prospective clinical trial.
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 document. The "ground truth" here is the amount of expelled sputum, which is a quantitative measurement, not something requiring expert consensus for its establishment in this context.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. The primary outcome measure (expelled sputum quantity) is a direct measurement, not an assessment requiring adjudication by experts.
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
- No, an MRMC comparative effectiveness study was not done. This device is a powered percussor for airway clearance, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in spirit, a standalone performance was assessed. The clinical trial directly evaluated the Frequencer™ device's effectiveness (as a standalone therapy or component of therapy) in terms of sputum clearance against a traditional method (CCPT). There is no "algorithm" in the AI sense, but the device's inherent function was tested on its own.
7. The Type of Ground Truth Used
- The ground truth used was outcomes data, specifically the quantity of expelled sputum (in grams).
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Frequencer™ is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's design and operating parameters would have been developed through engineering and physiological understanding, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reason as point 8. The "training" for such a device involves engineering design, prototyping, and testing, not establishing ground truth for a dataset.
§ 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).