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The DHD TheraPEP® is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis. The device may be used in conjuction with aerosol drug therapy.
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.

The DHD TheraPEP® is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.
Air and aerosolized drugs are drawn in through the inlet of TheraPEP, which is opposite the mouthpiece end of the device. The air and aerosolized drug passes by the inlet valve which baffles out some of the medication, primarily large diameter particles of aerosolized drug which can not be absorbed by the patient's lung tissue. The air and respirable diameter particles of the aerosolized drug continue undeterred past the inlet device and through the device past the mouthpiece and into the patient's body. As the user begins exhaling, the inlet valve closes, forcing all of the air from the lungs out the selected orifice in the selector dial.
The MDI with spacer or Nebulizer may be connected directly or by means of an adapter to the 22mm O.D. inlet end (opposite mouthpiece end) of the TheraPEP device. Positive Expiratory Pressure (PEP) occurs during exhalation and aerosol drug delivery occurs during inspiration. Use of an MDI Spacer and/or Nebulizer requires the same technique of breathing for inhalation and breath hold as does PEP therapy. A patient would be instructed by a clinician to take in a larger than normal breath for PEP Therapy or Aerosol Drug delivery followed by a short breath hold prior to exhalation. PEP occurs during exhalation and helps prolong exhalation plus keeps airways open longer thereby helping to move secretions, increase the transpulmonary pressure gradient, and resolve atelectasis.

The provided text describes modifications to the TheraPEP device and studies conducted to support an added claim regarding its use with aerosol drug therapy. However, it does not detail specific "acceptance criteria" in the form of numerical performance targets (e.g., minimum sensitivity or specificity) or a formal "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or screening device.

Instead, the studies summarized aim to demonstrate substantial equivalence to existing devices and that the added claim does not negatively impact safety and effectiveness. The "acceptance criteria" here appear to be more about demonstrating equivalency and non-inferiority in terms of drug delivery characteristics, rather than meeting predefined performance thresholds for a new clinical outcome.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and a structured "proving" study:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" in the traditional sense for a diagnostic or screening device (e.g., specific thresholds for sensitivity, specificity, or accuracy). Instead, the performance evaluation in this submission focuses on demonstrating equivalence in drug delivery performance to predicate devices and that the new configurations (with nebulizer and MDI spacer) do not negatively impact performance.

The implicit acceptance criteria seem to be:

1. No significant difference in aerosolized drug delivery when the TheraPEP is used with MDIs (with spacer) or SVNs, compared to existing market products or the predicate device.
2. No statistically significant difference in total drug mass delivered or respirable drug mass delivered for different medications when compared to the predicate device in combination with nebulizers.
3. The added claim (combination with aerosol drug delivery) will not adversely affect the safety and effectiveness of the TheraPEP device.

Therefore, the "reported device performance" is largely framed in terms of "no difference" compared to predicate devices or current market offerings.

Study Information Details:

1. Sample size for the test set and data provenance:

   • Phase I Testing: Not explicitly stated for each comparison, but the overall context of 510(k) submissions for such devices often involves in vitro laboratory testing rather than human subject trials. The phrasing "various products currently on the market" suggests comparative testing.
   • Phase II Testing: "small sample size (n=3)" was explicitly mentioned for the comparison between TheraPEP® and Resistex® for Intal® and Alupent® drug delivery.
   • Data Provenance: The studies appear to be laboratory-based in vitro evaluations of particle size distribution using cascade impaction measurement. Therefore, there is no "country of origin of the data" or "retrospective/prospective" context in the typical clinical study sense.

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

   • Not applicable as the studies were in vitro laboratory tests measuring particle size distribution and drug mass, not clinical evaluations requiring human expert interpretation for ground truth. The "ground truth" was established by the physical measurements themselves.

3. Adjudication method for the test set:

   • Not applicable. The studies involved quantitative physical measurements, not human interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This was not an MRMC study. The studies evaluated device performance in terms of drug delivery characteristics, not reader performance with or without AI assistance.

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

   • Yes, in a sense. The studies were "standalone" in that they evaluated the physical performance of the device and its compatibility with other components (nebulizers, MDIs) without human operation or interpretation as a variable in the outcome measurements. This aligns with the "algorithm only" concept for a physical device, where its intrinsic function is tested.

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

   • The "ground truth" for these studies was based on quantitative physical measurements using a cascade impactor to determine particle size distribution and total drug mass delivered. This is an objective measurement rather than an interpretive or clinical ground truth.

7. The sample size for the training set:

   • Not applicable. These were in vitro verification and validation studies, not machine learning model development. Therefore, there is no concept of a "training set."

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

   • Not applicable, as there was no training set.

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