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The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

The device is intended for home or institutional use by patients weighing at least 23 Kg.

The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.

Electro Flo® 6 Airway Clearance System comprises:

• An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
• The Power Head, connected by a cable to the Control Box, ●
• The Carrying Case,
• The Information Manual, ●
• The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.

The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.

When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.

The provided text is a 510(k) premarket notification for the Electro Flo® 6 Airway Clearance System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone testing.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and detailed standalone algorithm performance, are not applicable or not present in this type of FDA submission document.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of specific performance acceptance criteria for clinical outcomes or diagnostic accuracy per se. Instead, it focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of indications for use, intended use, and technological characteristics.

The "performance data" section (Section XI) refers to bench testing to characterize mechanical performance and verify its nature as a high-frequency chest wall oscillator.

2. Sample Size for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. The "test set" here refers to bench testing of the device itself, not a clinical patient cohort. The testing involved various settings (frequency, power, static loads) on a single physical device within a controlled laboratory setup.
• Data Provenance: The bench testing was conducted by Aeromethod Precision Engineering and Manufacturing, San Diego, CA, and analysis was performed by BioMedical Strategies, White River Junction, VT. This is laboratory-generated data, not from patient populations. It is inherently "prospective" in the sense of being planned testing, but not clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. For this type of mechanical device and 510(k) submission, "ground truth" is established through engineering and physics principles, and measured physical parameters, not expert human interpretation of complex data (like radiology images). The objective measurements from the bench test served as the data.

4. Adjudication Method for the Test Set:

Not applicable. There was no "adjudication" necessary as the test involved objective mechanical measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a therapeutic/clearance system, not a diagnostic AI tool, so a MRMC study is not relevant to its performance demonstration. The submission focuses on comparison to predicate mechanical devices.

6. Standalone (i.e., algorithm only without human-in-the-loop performance):

• Yes, in the context of mechanical performance. The "bench data" section describes the standalone mechanical characterization of the device itself.
• The study demonstrated that the device, on its own when operated, functions as a high-frequency chest wall oscillator and its power output can be controlled.

7. Type of Ground Truth Used:

• Engineering/Physics Measurements: The ground truth for the bench testing was objective, quantitative measurements of mechanical output (vibration data, power spectra) collected from the device under controlled laboratory conditions, analyzed based on established engineering and physics principles.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. Its design and development would have involved engineering principles and iterative testing, but not "training data" in the AI context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the AI/ML sense for this device.

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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.

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.

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