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AllerBlock Junior is intended for use in adults and children (8 years or older) to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor environmental pollens, house dust, animal hairs, and dust mites.

Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.

When the powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis (AR) symptoms.

The provided text is a 510(k) summary for AllerBlock Junior, a medical device intended to alleviate mild allergic symptoms. The document focuses on demonstrating substantial equivalence to a predicate device and extending its indications for use to include pediatric patients (8 years or older).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as a set of predefined quantitative thresholds that the device must meet for clearance. Instead, it presents summaries of clinical studies to demonstrate the device's safety and effectiveness, especially for the extended pediatric indication. The "reported device performance" is largely qualitative, focusing on symptom reduction and safety.

• Biocompatibility: Tests (cytotoxicity, sensitization, irritation) showed "no biocompatibility concerns."
• Adverse Effects in Children (5 studies, N=219 total pediatric patients): "reported adverse effects and complications were few in number (2-15%) and mild in level of severity." |
  | Effectiveness (Pediatric) | Alleviation of mild allergic symptoms (nasal irritation, itchy, runny, congested nasal passages). Reduced allergen exposure via mechanical barrier. | - Mechanism: Produces a mucous-like gel barrier that coats nasal membranes, blocking inhaled allergens.
• Study 1 (Mucociliary Clearance): "Significant decrease of clearance observed in children... after treatment (especially those with mean value > 31 minutes) is due to the effect of cellulose." This implies the formation of the barrier.
• Studies 2-5 (AR Symptom Scores): "all showed consistent reductions in AR symptoms including nasal congestion and discharge, sneezing, nasal and ocular itching." This directly supports alleviation of mild allergic symptoms. |
  | Shelf Life/Stability | Device maintains functionality and safety over its intended storage and use duration. | - Stability/Shelf Life Testing: "results support a shelf life of ≥ 3 yrs at 40°C." |
  | Product Formulation | New formulation (strawberry scent, 3%) should maintain safety and effectiveness comparable to predicate. | - Ingredients: HPMC Powder 97%, Strawberry Powder 3%. Strawberry scent recognized as GRAS.
• Particle Size: "Powder particle size remains essentially unchanged."
• Conclusion: "This change continues to support product safety and effectiveness." |

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

• Total Pediatric Patients Across 5 Studies: N=219.
  • Study 1: N=100 children
  • Study 2: N=23 children
  • Study 3: N=25 children
  • Study 4: N=30 children
  • Study 5: N=41 children
• Data Provenance: Not explicitly stated regarding the country of origin for each study. However, the author names (e.g., Aivazis V, Bourli E; Zakharzhevskaya T, Sidorenko I; Aberg N, Dahl A, Benson M; Geppe N, Snegotskaya M; Chen X, Guan WJ, Sun SX) suggest a mix of international (possibly European, Russian, Chinese) origins for the studies. The studies are described as "clinical studies," implying they are prospective, designed trials.

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 use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation.
• The "ground truth" for these studies is based on clinical outcomes:
  • Mucociliary clearance measurements (Study 1).
  • Patient-reported daily symptom scores for allergic rhinitis (Studies 2-5).
  • Clinical assessment of adverse events by study investigators.
• The qualifications of the clinicians/investigators conducting these studies are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1 or 3+1 for discordance resolution) are typically used in studies involving expert interpretation of images or other subjective data to establish a definitive ground truth.
• These clinical studies primarily relied on objective measurements (mucociliary clearance) and patient-reported outcomes (symptom scores). There is no mention of an adjudication method in this context. Adverse events would be reported and managed by the study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• MRMC studies are typically used to assess the impact of AI on human reader performance, usually in image-based diagnostic tasks. The AllerBlock Junior device is a physical barrier product, not an AI diagnostic tool.
• The comparative effectiveness in the provided studies refers to comparing the device to placebo or standard of care (oral medications, nasal steroids in Study 4 and 5).

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

• This question is not applicable. AllerBlock Junior is a physical device, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is directly tied to its physical application and effect on the user.

7. The Type of Ground Truth Used:

• Clinical Ground Truth:
  • Mucociliary Clearance: An objective physiological measurement.
  • Patient-Reported Outcomes (PROs): Daily symptom scores for allergic rhinitis (e.g., nasal congestion, discharge, sneezing, itching). These are subjective but are standard clinical endpoints for allergy studies.
  • Adverse Event Reporting: Clinical observation and reporting of adverse effects by study participants and investigators.

8. The Sample Size for the Training Set:

• The document does not describe a "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and effectiveness.
• The device's formulation (HPMC with strawberry scent) is based on established knowledge of HPMC as a safe and effective barrier and strawberry as a GRAS flavoring, not derived from training on a dataset.

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

• This question is not applicable as there is no "training set" in the machine learning sense for this device. The underlying principles for the device (HPMC forming a barrier) are based on scientific understanding and prior uses of these materials.

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Alzair Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airbone allergens including indoor environmental pollens, house dust, animal hairs and dust mites.

Application of nasal ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

Alzair Allergy Blocker is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 98.5%) and high quality peppermint (1.5%) which has been formulated into a micronized powder of fine particles of inert cellulose. Alzair Allergy Blocker is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.

When Alzair Allergy Blocker powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.

The provided FDA 510(k) summary for the Alzair Allergy Blocker does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as one would typically find for a diagnostic or imaging device.

This document is a 510(k) premarket notification for a Class II medical device, which generally relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than comprehensive clinical trials with detailed performance metrics and sample sizes like a PMA application would require.

Here's an analysis of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" (e.g., sensitivity, specificity, accuracy thresholds) or corresponding "reported device performance" metrics are provided in this document. The device is not a diagnostic tool where such metrics would be typical. Its performance is described in terms of its mechanism of action and historical safety.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not applicable and not provided. The substantial equivalence argument relies on the physical characteristics and intended use being similar to the predicate device, along with safety and biocompatibility testing. There isn't a "test set" in the sense of a set of patient data being evaluated against a ground truth.
• Data provenance: Not directly applicable to a performance study for this type of device. The historical safety data mentioned is global, as the predicate device has been sold in "more than 50 countries worldwide."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment by experts for a test set described in this submission.

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

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is a topical nasal powder, not an algorithm.

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

Not applicable. The document focuses on demonstrating the device's physical properties, biocompatibility, and history of safe use, rather than accuracy against a ground truth for a diagnostic claim. The "clinical studies" mentioned in the conclusion refer to previous work for the predicate device, demonstrating reduction of nasal allergen exposure and symptoms, which would be a form of clinical outcomes data.

8. The sample size for the training set

Not applicable. This device is not a machine learning model.

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

Not applicable. This device is not a machine learning model.

Summary of available information regarding performance and proof:

• Device Name: Alzair Allergy Blocker
• Intended Use: To treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens. It forms a mucous-like gel barrier to block inhaled allergens.

Proof of Performance (as described in the 510(k) Summary):

The proof provided is primarily based on substantial equivalence to a predicate device (K132520 - Allergy Blocker, Nasal Eze International) and supporting evidence for safety and mechanism of action.

• Mechanism of Action: When Alzair Allergy Blocker powder comes into contact with the moist nasal mucosa, it forms a colorless, mucus-like fine gel that coats the inside of the nasal cavity. This inert gel acts as a mechanical barrier, making it more difficult for inhaled allergens to contact the nasal lining, thereby reducing the intensity of allergic rhinitis symptoms.
• Safety Testing & Toxicology: HPMC and peppermint are recognized as GRAS (Generally Recognized As Safe) in the US. The concentration, grade, and route of administration are considered safe and below known toxicological levels.
• Biocompatibility: Testing included cytotoxicity, sensitization, and irritation, with results demonstrating no biocompatibility concerns.
• Stability and Shelf Life: Testing supports a shelf life of at least 3 years at 40°C.
• History of Safe and Effective Use (Predicate Device): The predicate, Nasaleze Allergy Blocker (with identical formulation), has been registered as a Class I Medical Device since 1991 and sold in over 50 countries for more than 25 years. During this period, over 7,000,000 products have been sold with no reports of serious adverse events.
• Clinical Studies (Predicate Device): The summary states, "Clinical studies have demonstrated that the allergy blocker's mucous-like gel barrier is beneficial to hay fever sufferers through the reduction of nasal allergen exposure and consequently a reduction in symptoms from seasonal allergic rhinitis." No specifics of these studies (e.g., sample size, design, results) are provided in this document, as the FDA typically would have reviewed these as part of the predicate's original submission.

In conclusion, for this specific device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate, along with safety (toxicology, biocompatibility) and stability data, and referencing previously established clinical benefits of the predicate device's formulation. There are no quantitative performance metrics like sensitivity/specificity or sample sizes for an independent test set in this 510(k) submission.

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