(168 days)
The Frequencer™ 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™ v2x is only intended for use in hospitals and clinics.
The Frequencer™ 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 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 65 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits. This model is intended for use in hospital and clinic settings only and disposable filters are available for multi-patient use.
The provided text describes the Dymedso Frequencer™ v2x, an airway clearance device, and its performance testing to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain details about acceptance criteria directly in a clear, tabulated format with specific performance metrics and their corresponding reported values for the Frequencer™ v2x itself.
Instead, the document focuses on:
- Comparison to a predicate device: Frequencer™ 1001.
- Bench testing results: demonstrating "similar, though slightly lower maximum applied force" compared to the predicate. This comparison is not a direct measure against specific acceptance criteria for the Frequencer™ v2x's therapeutic effect.
- Reference to prior clinical testing on the original Frequencer: which showed "comparable sputum weights" and "higher flow rates of mucus in vitro." These are findings from the predicate device's studies, not new studies for the v2x.
- Compliance with safety and electromagnetic standards: IEC 60601-1 and IEC 60601-1-2. These are general safety standards, not performance criteria for its therapeutic indication.
Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details for training/test sets) for the Frequencer™ v2x are not explicitly stated in this 510(k) summary. The summary focuses on showing that the Frequencer™ v2x is substantially equivalent to the Frequencer™ 1001 due to identical indications, operating principles, electronics, and similar basic performance (force applied).
Given the limitations of the provided text, here's an attempt to answer the questions based only on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
As specific therapeutic acceptance criteria for the Frequencer™ v2x (e.g., minimum sputum weight, minimum mucus flow rate) are not explicitly stated or quantified in this 510(k) summary, and the performance testing primarily focused on comparison to a predicate device and compliance with general safety standards, a direct table of acceptance criteria vs. specific reported values for the v2x's therapeutic efficacy cannot be fully constructed from the provided text.
The closest we can infer for "acceptance" is substantial equivalence to the predicate device.
| Acceptance Criterion (Inferred from Text) | Reported Device Performance (Frequencer™ v2x) |
|---|---|
| Mechanical Performance: Maximum force applied (comparison to predicate) | "similar, though slightly lower maximum applied force in comparison to the predicate." "Both devices still provide considerably lower forces than applied during Conventional Chest Physiotherapy (CCPT)." |
| Electrical Safety: Compliance with IEC 60601-1 | Tested in accordance with IEC 60601-1 (Implicitly, it met the standard for a Type A device). |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 | Tested in accordance with IEC 60601-1-2 (Implicitly, it met the standard for a Type A device). |
| Software Validation: Functionality and safety | "Software verification and validation testing has also been performed on the device." (Implicitly, it met validation criteria). |
| Overall Equivalence: Identical to predicate in key aspects | "The proposed Frequencer™ v2x has the identical indications, operating principle and electronics as the predicate device Frequencer™ 1001." |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" with a defined sample size for the Frequencer™ v2x. The clinical data referenced pertains to the original Frequencer™ (the predicate device). The performance testing for the v2x appears to be bench testing for mechanical force comparison and compliance testing for safety standards.
- Sample Size for Frequencer™ v2x performance testing: Not specified. It refers to "Performance bench testing" but not specific numbers of tests or devices.
- Data Provenance for Frequencer™ v2x: Not explicitly stated, implied to be laboratory bench testing undertaken by the manufacturer (DYMEDSO, Inc.) in Canada.
- Clinical data provenance (for predicate device results): Not detailed (e.g., country of origin, retrospective/prospective). It only mentions "Clinical testing conducted on the original Frequencer™."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical "test set" and ground truth establishment involving human experts for the Frequencer™ v2x performance evaluation. The clinical claims for efficacy are based on the predicate device's studies, for which expert involvement is not described in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication by experts is described for the Frequencer™ v2x.
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. The Frequencer™ v2x is an airway clearance device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Frequencer™ v2x is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Frequencer™ v2x performance, the "ground truth" was its mechanical performance measured against the predicate device and compliance with safety standards. For the predicate device's efficacy data, the "ground truth" appears to be:
- "comparable sputum weights produced after treatment" (clinical outcome).
- "higher flow rates of mucus through a capillary tube" (in vitro laboratory measurement).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set."
§ 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).