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HayMax™ organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (i.e, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.

HayMax™ is a drug free viscous topical nasal balm consisting of a mixture of organic beeswax and organic sunflower oil. There are three further variants: one containing organic freeze dried 200:1 Aloe Vera powder, another containing organic Lavender essential oil and the last containing organic Frankincense essential oil, all in very small quantities.

HayMax™ is used as a pollen blocker prophylaxis for seasonal allergic rhinitis caused by airborne allergens. The product is sparingly applied around the base of the nostrils with a finger, or suitable applicator, eq., cotton swab. where it acts as a mechanical barrier. It traps pollen before it reaches the nasal cavity, thus reducing pollen entering the body. If this maintains the pollen (or other airborne allergen) in a person's body below their sensitivity level then they will not react to the allergen. It is reapplied regularly as required, and after sneezing or blowing the nose. It is intended for topical use and is provided non-sterile. The balm is chemically inert to the body and nasal membranes, and is certified organic.

The provided 510(k) submission for HayMax™ Pollen Barrier Nasal Balms does not present a typical set of acceptance criteria with corresponding performance metrics in a structured table or a detailed study designed to meet specific statistical endpoints for regulatory clearance in the way that many medical devices do.

Instead, the submission for HayMax™ focuses on demonstrating "substantial equivalence" to predicate devices, supported by a combination of inherent product characteristics (drug-free, natural, organic), a simple internal trial, independent research, testimonials, and independent reviews. The primary "acceptance criteria" here appear to be demonstrating safety, physical similarity, and similar intended use to the predicates, rather than proving a specific clinical efficacy target through a controlled trial.

However, I can extract the relevant information and present it in a structured way based on the available document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission doesn't define explicit quantitative "acceptance criteria" in the traditional sense. The device's "acceptance" is primarily based on demonstrating substantial equivalence to predicates and inherent safety.

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

The document refers to a "simple trial" (Appendix 2) and "independent research" by NPARU (Appendices 3 and 6). However, the provided summary does not include the details of these appendices. Therefore, the specific sample size, country of origin, and whether the data was retrospective or prospective for these studies cannot be determined from the provided text.

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

The document mentions "independent research on HayMax™ pollen barrier balm carried out by The National Pollen and Aerobiology Research Unit (NPARU), University of Worcester." While this institution suggests an expert setting, the number of experts and their specific qualifications for establishing 'ground truth' (e.g., pollen counts, symptom assessment) are not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the studies mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence rather than a direct comparison of human reader performance with and without AI assistance. The device itself is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical balm, not an algorithm or software. Its performance is inherent in its physical properties and intended use.

7. The Type of Ground Truth Used

Based on the nature of the device (pollen blocker for allergic rhinitis), the "ground truth" for the effectiveness studies would likely involve:

• Pollen counts: To measure the amount of pollen trapped or blocked.
• Symptom assessment: Patient-reported outcomes or clinical scoring of allergic rhinitis symptoms (e.g., nasal irritation, itching, runny nose, congestion).

However, the specific methods for establishing this ground truth are not detailed in the provided summary.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical product and does not involve machine learning algorithms requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

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