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The Alergol Pollen Blocker Cream is intended to promote alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs, and dust mites.

Alergol Pollen Blocker Cream is a viscous topical nasal cream consisting of highly refined aliphatic long-chain hydrocarbons for prophylaxis and therapy of allergic rhinitis caused by airborne allergens. The product is applied by finger or cotton swab to the inside surface of the nasal vestibule in the region of the nose flap where it acts as a mechanical barrier to reduce the adverse effects of inhaled allergens. Proper application of the cream makes it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reduces the intensity of allergic rhinitis symptoms.

The hydrocarbon gel is chemically inert to the body and nasal membranes, and contains no additives. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied. The Alergol Pollen Blocker cream is intended for topical use and provided non-sterile.

Here's an analysis of the acceptance criteria and study details for the Alergol Pollen Blocker Cream, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for symptom reduction or airflow change that the device needed to meet to be considered "effective." Instead, the studies demonstrate "significant" effectiveness compared to placebo.

2. Sample Size and Data Provenance for Test Set:

• Sample Size:
  • Study 1: N=50
  • Study 2 (referenced as S. Schwetz et al.): N=91 (43 in pollen blocker cream group, 48 in carboxymethylcellulose gel/placebo group).
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as "multicenter." The manufacturer, Dr. Theiss Naturwaren GmbH, is a German company, which might suggest European studies, but this is not explicitly confirmed.
• Retrospective or Prospective: Prospective. The studies are described as "multicenter, prospective, randomized, double-blind, placebo-controlled crossover studies."

3. Number of Experts and Qualifications for Ground Truth (Test Set):

The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic imaging. Instead, the efficacy was assessed by:

• Nasal provocation testing: Likely administered and interpreted by clinical staff or researchers involved in the study.
• Nasal symptom severity scores (range 0-6): These are subjective patient-reported or clinician-observed scores.
• Changes in nasal airflow after allergen challenge: Measured objectively by instruments.

Therefore, the "ground truth" here is derived from quantitative and qualitative clinical measurements and patient self-reporting, not an expert panel reviewing cases.

4. Adjudication Method for the Test Set:

Not applicable in the context of symptom scores and objective physiological measurements for this type of device. The studies were designed as "double-blind," meaning neither the patients nor the clinicians/evaluators knew which treatment (active or placebo) was being administered, which serves to minimize bias in assessment.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (e.g., imaging AI) where multiple readers interpret cases with and without AI assistance. The Alergol Pollen Blocker Cream is a therapeutic/prophylactic device, and its effectiveness was measured through symptom reduction and physiological changes in patients, not through diagnostic interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Alergol Pollen Blocker Cream is a physical product (cream) applied by the user, not an algorithm. Therefore, there is no "standalone algorithm" performance to report. Its effectiveness is inherently tied to human application.

7. Type of Ground Truth Used:

The "ground truth" for evaluating the device's effectiveness was based on:

• Clinical Endpoints:
  • Patient-reported symptom scores: Subjective measure of allergic rhinitis symptoms (e.g., itching, runny/congested nose).
  • Objective physiological measurements: Specifically, nasal airflow resistance and changes in airflow after allergen challenge.
• The "effectiveness" was determined by comparing these clinical endpoints between the active treatment group and a control/placebo group.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/machine learning algorithm that requires a "training set" of data.

9. How Ground Truth for Training Set Was Established:

Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth establishment process.

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