(157 days)
The intended use of the Med Systems Electro Flo Percussor Model 5000 is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.
This document describes the Med Systems Electro Flo Percussor Model 5000, a powered chest percussor. The submission focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted from this document, as this is a 510(k) for a physical medical device, not an AI/software device.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not contain specific performance acceptance criteria or reported device performance data in the traditional sense (e.g., sensitivity, specificity, AUC) because it's a submission for a physical medical device demonstrating substantial equivalence. The "performance" is implicitly tied to its functional similarity to predicate devices.
The table below summarizes the comparison to predicate devices, which serves as the basis for demonstrating substantial equivalence. The new device is accepted if it performs "as safe and effective as the predicate devices," primarily by matching their indications for use and having comparable technical specifications.
| Feature | Predicate Device Performance / Acceptance Criteria (implied based on predicate) | Reported Device Performance (Med Systems 5000 Electro Flo) |
|---|---|---|
| INDICATION for USE | Same as predicate (respiratory secretion clearance for COPD, cystic fibrosis, emphysema, atelectasis and other obstructive lung conditions) | SAME |
| Power and Control | Pneumatic Solenoid, Electric Solenoid, or Electric Motor (from predicates) | Electronic Solenoid |
| Speed | 5 to 60 Hz (range from predicates) | 5 to 25 Hz |
| Weight | 1.5 to 5 pounds (range from predicates) | 1.5 pounds |
| Energy source | Pneumatic or 120 v 60 Hz AC (from predicates) | 120 v 60 Hz AC |
Note: The "acceptance criteria" here are implicit in the comparison to the predicate devices. The new device is considered acceptable if its features and indications for use are equivalent to or fall within the established safe and effective parameters of the predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This is not a study involving a "test set" of patient data for an AI/diagnostic device. The submission relies on "bench and electrical safety testing data" and comparison of technical specifications to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No "ground truth" for a test set in the context of diagnostic performance was established for this device submission.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
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 device or a diagnostic device where human reader performance is evaluated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Bench and electrical safety testing were performed, but these are not "standalone" performance evaluations in the AI context.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence claim is primarily the established safety and effectiveness of the legally marketed predicate devices. The new device's performance is measured against the specifications and known clinical utility of these predicates through a comparison of technological characteristics and intended use.
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. No training set was used.
§ 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).