Search Results

The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice for increasing the clearance of mucus in patients with pulmonary disorders. The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).

The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.

Here's an analysis of the provided text regarding the acceptance criteria and study for "The inCourage™ System":

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the typical format of a target value or range for performance metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

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 "test set" in the context of clinical data from patients. The performance testing described is focused on the functional characteristics of the device itself rather than its efficacy in a patient population. Therefore, there's no mention of sample size for a test set or data provenance from countries.

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)

Not applicable. The study is a comparison of technological characteristics and functional performance against a predicate device, not a clinical study requiring expert assessment for ground truth on patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring adjudication. The "conclusion" of substantial equivalence was made by the submitter, Respiratory Technologies Inc., D.B.A. RespirTech.

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 MRMC study was conducted. This device is a powered percussor for airway clearance, not an AI-assisted diagnostic or therapeutic tool with human reader involvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the device's functional performance without direct human intervention after initial setup, in comparison to the predicate device. The performance testing was a standalone comparison of the inCourage™ System's waveform characteristics (pressure, rate, volume) to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established functional and performance characteristics of the predicate device, The Vest™ Airway Clearance System, Model 104. The inCourage™ System demonstrated that its own functional characteristics were comparable to this established baseline.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device