(288 days)
The Electromed Medpulse™ RespiratoryVest System is designed specifically to deliver I its Lievency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid in bronchial mucus clearance. The system consists of an air-pulse generator, an inflatable vest and air connection tubing. Alternating positive pressure air pulses are delivered to the inflatable vest via the air-pulse generator. Rapidly alternating positive pressure air pulses result in the inflation and deflation of the vest which frequency chest wall oscillation to the patient and thus enhances clearance of mucus from the lungs. The frequency of the air-pulses, time settings and amount of pressure are operator controlled according to physician's prescription.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medpulse™ Respiratory Vest System:
The provided document set is a 510(k) submission for the Medpulse™ Respiratory Vest System. It's important to note that 510(k) submissions don't typically involve extensive clinical trials with human subjects or detailed performance metrics like sensitivity/specificity for AI devices. Instead, they focus on demonstrating "substantial equivalence" to a predicate device already on the market.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ThAIRapy® Vest System) regarding: | "The Electromed Medpulse™ System was functionally compared and performance tested against the predicate ThAIRapy® System which resulted in a demonstration of substantial equivalence regarding pressure amplitude, pulse frequency, pressure waveform shape, and thus performance." |
| - Form | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to form..." |
| - Fit | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to...fit..." |
| - Function | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to...function." |
| - Intended Use | "Electromed, Inc. believes that their Medpulse™ Respiratory Vest System is substantially equivalent to the Predicate system with regard to...intended use." |
| - Pressure Amplitude | Demonstrated substantial equivalence |
| - Pulse Frequency | Demonstrated substantial equivalence |
| - Pressure Waveform Shape | Demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for performance testing. The "performance testing" described is a functional comparison against a predicate device, not a human clinical trial involving a "test set" in the context of device performance metrics like sensitivity/specificity. The data provenance is not specified, but it's implied to be from Electromed, Inc.'s own internal testing.
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)
This information is not applicable to this 510(k) submission. There was no "ground truth" to establish for a "test set" in the way it would be for an AI or diagnostic device. The comparison was functional and technical against a known predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No adjudication method is mentioned because there was no clinical "test set" requiring expert review for ground truth establishment.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices that interact with human readers (e.g., radiologists interpreting images). The Medpulse™ Respiratory Vest System is a physical therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Medpulse™ Respiratory Vest System is a physical device, not an algorithm. Its "performance" is inherent in its mechanical operation and its ability to deliver specified oscillation parameters.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission was the established performance and technical characteristics of the predicate device, the ThAIRapy® Vest System. The aim was to show that the Medpulse™ system matched these established characteristics. There was no clinical ground truth established through expert consensus, pathology, or outcomes data for this specific submission's performance testing.
8. The sample size for the training set
This information is not applicable. The Medpulse™ Respiratory Vest System is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).