(329 days)
The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.
The subject device provides PEP only. The subject device is an oral device that provides positive expiratory airway pressures to enhance expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.
The provided submission for the Breathe+ device, a Positive Expiratory Pressure (PEP) device, does not contain a typical study that proves the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study. Instead, it focuses on bench testing and a comparison to predicate and reference devices to demonstrate substantial equivalence for FDA clearance.
Therefore, the following information will be drawn from the provided text regarding the bench testing that was performed for the device. The document does not describe a clinical study with an AI component or expert ground truth adjudication.
Acceptance Criteria and Reported Device Performance (Bench Testing)
| Acceptance Criteria (from predicate/reference or implied) | Reported Device Performance (Breathe+) |
|---|---|
| Exhalation Resistance (cmH2O) @ 20 lpm | 4.4 cmH2O @ 20 lpm |
| Exhalation Resistance (cmH2O) @ 30 lpm | 8.5 cmH2O @ 30 lpm |
| Exhalation Resistance (cmH2O) @ 40 lpm | 9.7 cmH2O @ 40 lpm |
| Repeatability of PEP values | Tested and found acceptable |
| Accuracy of PEP values | Tested and found acceptable |
| Functionality post-aging | Tested and found acceptable |
| Functionality post-repeated cleaning | Tested and found acceptable |
Note: The exact acceptance thresholds for "repeatability and accuracy" are not explicitly stated in the document, but the discussion concludes "The device performance was tested and does not raise any new concerns of safety or effectiveness."
Study Details (Bench Testing)
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Sample size used for the test set and the data provenance: Unspecified number of "final, finished samples" of the Breathe+ device. The data provenance is internal testing performed by PEEP Medical, LLC. It is prospective testing on newly manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was bench testing of a physical device's mechanical performance, not an AI or diagnostic study requiring expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was mechanical bench testing.
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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. No MRMC study was performed as this is a mechanical medical device, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench testing was based on direct physical measurements of the device's performance, such as pressure readings (cmH2O) at various flow rates (lpm) using calibrated equipment.
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The sample size for the training set: Not applicable. This refers to bench testing of a physical device.
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How the ground truth for the training set was established: Not applicable.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).