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The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.

The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.

The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.

Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.

Acceptance Criteria and Device Performance for AllPEP

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests (e.g., number of devices tested for aging, cleaning, or performance metrics).
   • Data Provenance: The tests are performed by the sponsor, Enchant Tek Co. Ltd., based in Taiwan. The data provenance is from bench testing (laboratory-controlled conditions) rather than clinical data from human subjects. The document does not specify if the testing was retrospective or prospective, but bench testing is typically considered prospective for the device being submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission relies on bench testing and biocompatibility test results, which compare device performance to pre-defined engineering and safety standards, and to a predicate device's characteristics. There is no mention of human expert-based ground truth establishment as would be relevant for a diagnostic AI device or clinical study.

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

   • Not applicable. No human readers or "ground truth" establishment by experts is described for this type of submission. The performance is gauged against pre-defined engineering specifications and comparison to the predicate device's established characteristics.

4. 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. This is a submission for a Positive Expiratory Pressure (PEP) device, which is a mechanical therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.

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

   • Not applicable. This device is not an algorithm or AI. It is a physical medical device. The "standalone" performance testing refers to the device's intrinsic mechanical performance (frequency, amplitude, pressure) as measured during bench tests.

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

   • The "ground truth" (or basis for acceptance) for this device is established through:
     • Pre-defined engineering and performance specifications based on the device's intended function and regulatory standards for incentive spirometers.
     • Comparison to the performance characteristics of a legally marketed predicate device (DHD Acapella K991561) to establish substantial equivalence.
     • International standards (ISO 10993-series and ISO 18562-series) for biocompatibility testing.
   • There is no medical "ground truth" (like disease presence from pathology or outcomes) as this is not a diagnostic device.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning product, so there is no concept of a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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