(90 days)
The Frequencer™ V2 or V2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy 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, postoperative 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™ V2 or V2x 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 electroacoustical power head (hereafter referred to as the "transducer") which is " placed externally on the patient's chest. The transducer is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The transducer induces sound waves in the patient's chest which are effective in loosening mucus deposits. The model V2x uses disposable adapters with filters and is intended for use in multi-patient settings. The model V2 uses a permanent non-filtering adapter and is intended for single patient use.
The Dymedso Frequencer V2™ and Frequencer V2x™ Airway Clearance Device is not an AI/ML device. The provided text describes a medical device for airway clearance therapy that induces vibrations in the chest walls. The performance testing conducted includes electrical safety, electromagnetic radiation, biocompatibility, and bench testing to compare applied force with a predicate device and conventional chest physiotherapy (CCPT). There is no mention of an algorithm, AI, or machine learning in the device's description or performance testing. Therefore, the specific criteria requested for AI/ML device evaluations (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.
Here's a summary of the performance testing and acceptance criteria as described in the document, which pertains to the physical and electrical characteristics of the device, and its safety:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Compliant | Device tested in accordance with IEC 60601-1 and met requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Consistent with Type B device for domestic environments | Device tested in accordance with IEC 60601-1-2 and met acceptance criteria for a Type B device for domestic environments. New ferrites added to allow home/residential use. |
| Biocompatibility | ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization & Irritation) | Passing all tests (Level 1 biocompatible, allows direct skin contact) | Base resin (Bayblend 301 FR) used for adapter heads passed all tests, considered Level 1 biocompatible. |
| Applied Force | Bench Testing | Comparability to predicate device (K100749) and lower forces than CCPT | Demonstrated similar, though slightly lower, maximum applied force compared to the predicate. Both provide considerably lower forces than CCPT. |
| Clinical Effectiveness (Historical Data for Predicate) | Clinical testing on original Frequencer™ (K100749) | Comparable sputum weights to CCPT in CF patients | Sputum weights produced after treatment with Frequencer™ were comparable to CCPT in subjects with Cystic Fibrosis (CF). |
| Mucus Flow Rate (In Vitro) | In vitro flow rate measurements | Higher flow rates using Frequencer™ compared to no treatment | Demonstrated higher flow rates of mucus through a capillary tube when using the Frequencer™ compared to no treatment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document references "Clinical testing conducted on the original Frequencer™" for sputum weights and "In vitro flow rate measurements," but does not specify sample sizes or data provenance for these studies. The primary testing for the V2 and V2x models focuses on electrical safety, EMC, biocompatibility, and a bench test for applied force, which do not typically involve patient "test sets" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The device is not an AI/ML device that generates outputs requiring expert ground truth for evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's physical and electrical operation, and its ability to induce vibrations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance assessment, the "ground truth" or reference points were:
- Safety and EMC Standards: IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility Standards: ISO 10993-5 and ISO 10993-10.
- Predicate Device Performance: Comparison of applied force to the Frequencer™ v2x (K100749).
- Conventional Chest Physiotherapy (CCPT): Used as a clinical benchmark for sputum weights and a comparison for applied force.
- No Treatment: Used as a benchmark for in vitro mucus flow rates.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).