(225 days)
The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.
The International Biophysics Corporation HFCWO Vibratory Vest is comprised of a vest of synthetic polymer fabric with installed oscillating vibratory motors organized into six zones. It has three buckles and straps on the front and one over each shoulder that are used to provide the wearer with a snug and evenly-distributed fit. Additionally, there is an included charger for the batteries and a remote that is wired into the vest to adjust the intensity of the oscillation on the patient as necessary and as prescribed by a physician.
The provided text is a 510(k) summary for the International Biophysics Corporation HFCWO Vibratory Vest. This document explicitly states that no clinical or nonclinical performance data was required or submitted for this device to establish substantial equivalence with predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
- Sample size used for the test set and the data provenance: No test set data exists.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment occurred.
- Adjudication method for the test set: No test set means no adjudication method.
- 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 such study was conducted or reported. This device is a vibratory vest, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established for performance testing.
- The sample size for the training set: No training set was used.
- How the ground truth for the training set was established: No training set means no ground truth establishment for it.
The 510(k) summary explicitly states:
- Nonclinical Performance Data: "None required"
- Clinical Performance Data: "None required"
The conclusion is based on substantial equivalence to existing legally marketed HFCWO vests, rather than on new performance data demonstrating meeting specific acceptance criteria through a study.
§ 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).