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Z-Net reduces for up to 15 months house dust mites and their allergens in bedding, a leading cause of allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers.

The Z-Net allergy control device consists of a mattress cover and pillow cover created from polyester impregnated with permethrin. The treated fabric reduces the levels of house dust mites (HDM) and their allergens in the mattress and pillow which, in turn, provides relief to individuals suffering from atopic allergies.

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Acceptance Criteria and Study Proving Device Meets Criteria:

Based on the provided 510(k) summary, the device is the Z-Net mattress and pillow covers, which are polyester impregnated with permethrin, intended to reduce house dust mites (HDM) and their allergens. The primary acceptance criterion is the long-term reduction of HDMs and their allergens in mattresses.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of subjects or items. The study refers to "test and placebo groups" and "dust samples" collected over time. It does not provide the specific count of mattresses, pillows, or homes involved.
• Data Provenance: The primary study was conducted at the London School of Hygiene and Tropical Medicine (LSHTM), indicating international data (United Kingdom). The study was prospective, described as a "two-year, double-blind study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not mention the number of experts used to establish the ground truth for the test set.
• It refers to the LSHTM laboratory conducting the analysis of dust samples, suggesting laboratory technicians or researchers with expertise in dust mite and allergen quantification. Specific qualifications (e.g., allergist, microbiologist, with X years of experience) are not provided.

4. Adjudication Method for the Test Set:

• The document describes the primary study as a "two-year, double-blind study." This indicates that neither the participants (those using the covers) nor the researchers/analysts were aware of whether they were in the permethrin-treated group or the placebo group. This blinding serves as a form of "adjudication" against bias in data collection and initial analysis, but it's not an adjudication method in the sense of multiple experts independently reviewing findings. No other multi-expert adjudication method (like 2+1 or 3+1) is mentioned.

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, an MRMC comparative effectiveness study was not done. This device is a physical product (mattress/pillow cover) and not an AI-based diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

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

• No, a standalone algorithm-only performance study was not done. As mentioned above, this is a physical device, not an algorithm.

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

• The ground truth was established through direct measurement of biological markers:
  • Quantification of "House Dust Mites (HDM)"
  • Quantification of "HDM allergens"
  • These measurements were derived from "dust samples" collected from mattresses.

8. The sample size for the training set:

• Not applicable. This device is a physical product that works through a chemical impregnation, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an AI/algorithm, no ground truth was established for it.

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