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Bentrio™ 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 airborne allergens including indoor and outdoor environmental pollens, animal hair and dust mites.

Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.

Bentrio™ is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives.

The gel formulation of Bentrio™ has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.

The provided text describes the regulatory clearance of a medical device, Bentrio™ Allergy Blocker, and its equivalence to a predicate device, Nasal Ease Allergy Blocker. It focuses on the device's mechanism of action, intended use, and the studies conducted to demonstrate its safety and clinical performance.

However, the document does not contain the kind of information typically found in acceptance criteria and study designs for an AI/ML medical device. Specifically, it does not mention:

• Acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI model.
• Sample sizes for test sets in the context of an AI model's validation.
• Number or qualifications of experts establishing ground truth for AI model training/testing.
• Adjudication methods for AI ground truth.
• MRMC studies for AI assistance.
• Standalone performance (algorithm only) of an AI.
• Ground truth types for AI models (e.g., pathology, outcomes data).
• Training set details for an AI model.

The document describes clinical studies for a physical medical device (nasal spray) to alleviate allergy symptoms. The "performance" discussed relates to the device's ability to reduce symptoms in human subjects, not the performance of an AI algorithm in classification or prediction tasks.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from the provided text. The questions posed in the prompt (1-9) are relevant to the validation of AI/ML medical devices, which is not the subject of this FDA clearance letter.

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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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RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.

The device consists of a filtering membrane/media and a frame. The filtering membrane is a planar filter made of polypropylene non-woven fibers. The frame is made of medical grade SEBS compound which is a biocompatible polymer designed for human skin contact. Each filter section in each nostril is connected via the frame's u-shaped bridge. The device is made in multiple sizes.

The device is inserted in the nostrils and is in contact with unbroken skin in the anterior vestibule of the nostrils (non-invasive). The device functions as a filtering device (mechanical barrier) that removes particles (pollen) from the inhaled air. The filter allows adequate air movement while breathing through the nose. The device is single-use and should only be used when exposed to allergens.

The provided document describes the Rhinix™ nasal filter and its substantial equivalence to predicate devices, supported by a clinical trial. However, it does not explicitly present acceptance criteria in a table format with reported device performance against those criteria. Instead, it discusses the findings of a clinical trial that serves to demonstrate the device's effectiveness.

Here's a breakdown of the information that can be extracted, and where details are missing, it will be noted:

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

The document does not provide a formal table of acceptance criteria. However, based on the clinical trial results, the implicit criteria can be inferred from the statistically significant improvements observed.

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

• Sample Size for Test Set: The document mentions a clinical trial (NCT01699165) which is a "randomized, double-blind, placebo-controlled crossover clinical trial." However, the specific number of participants (sample size) in this trial is not provided in the given text.
• Data Provenance:
  • Country of Origin: Not explicitly stated in the provided text.
  • Retrospective or Prospective: The study is described as a "randomized, double-blind, placebo-controlled crossover clinical trial," which is a prospective study design.

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)

This information is not provided in the document. For a self-administered device like a nasal filter for hay fever, ground truth on symptom reduction would typically be self-reported by patients using validated questionnaires or symptom scores. Expert consensus for ground truth on patient-reported outcomes is not usually applicable in this context.

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

This information is not applicable/provided. Adjudication methods are typically used when there are subjective interpretations of medical images or other complex data requiring multiple expert reviewers. For a clinical trial assessing symptom reduction of a physical device, the outcome measures are usually direct patient reports or objective physiological measurements, not requiring adjudication in the sense of expert review of initial assessments.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI tools, not for a physical device like a nasal filter.
• Effect Size of AI assistance: This is not applicable as there is no AI component described for this device.

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

• Standalone Performance: Yes, in a way. The clinical trial investigated the performance of the Rhinix™ nasal filter as a standalone device in alleviating symptoms. It is a physical device, so "algorithm only" or "human-in-the-loop" are not directly applicable concepts in the same way they would be for a software device. The clinical trial assessed the device's efficacy on its own when used by individuals.

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

The ground truth for the clinical trial would be based on patient-reported outcomes data, specifically questionnaires or scales measuring symptoms of allergic rhinitis (e.g., Total Nasal Symptom Score - TNSS) and perception of nasal resistance.

8. The sample size for the training set

This information is not applicable/provided. A "training set" refers to data used to train machine learning models. The Rhinix™ nasal filter is a physical medical device, not a software algorithm that requires training data in the machine learning sense. The clinical trial described is for validation, not training.

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

This information is not applicable/provided for the reasons stated in point 8.

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Nasal Ease 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 airborne allergens including indoor and outdoor 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.

Nasal Ease Allergy Blocker is composed of 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC) which has been formulated into a micronized powder of fine particles of inert cellulose. Nasal Ease 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 Nasal Ease 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 nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.

One bottle squeeze releases around 3.2mg of powder. The maximum usual dose is around 3 puffs/day into each nostril, giving a total of 19mg/day.

The cellulose gel is considered inert and does not penetrate the dermal layer of the skin. On average, protection lasts for 4-6 hours before the gel has to be re-applied. Nasal Ease is intended for topical use and provided non-sterile.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

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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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NasalGuard® 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.

NasalGuard is a water-based gel consisting of common, GRAS cosmetic grade ingredients. The product is applied by finger or cotton swab to the outside of the nasal passages, around the nostrils and upper lip. NasalGuard utilizes a patented methodology that uses the cationic properties of its ingredients to create an electrostatic field that attracts and blocks airborne allergens before they enter the nasal passages. The gel is considered innocuous and does not penetrate the dermal layer of the skin. The gel is concentrated and lasts for 4-6 hours before the gel has to be reapplied. NasalGuard is intended for topical use and provided non-sterile.

Here's an analysis of the provided text regarding the NasalGuard device, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 43 subjects for the clinical efficacy study.
• Data Provenance: Not explicitly stated, but the submission is from Denison Pharmaceuticals, Inc. c/o Trutek Corporation, with the device itself being "Unclassified." The predicate device is from Dr. Theiss Naturwaren Gmbh, Germany. The clinical study was likely conducted in the US, but this isn't clarified. The study was prospective (a "double blind, crossover study").

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

• This information is not provided in the document for the clinical study. The "ground truth" for the clinical study would likely be the reported allergic symptoms of the subjects.

4. Adjudication Method for the Test Set

• The document states it was a "double blind, crossover study." This implies that neither the subjects nor the researchers administering the treatments and collecting data knew which treatment (NasalGuard or active control Alergol) was being given. However, a specific "adjudication method" for interpreting or validating clinical outcomes (e.g., by an independent panel) is not 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

• No, an MRMC comparative effectiveness study was not done. This device is a topical gel, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, this is not applicable. The device is a physical product (gel) and not an algorithm.

7. The Type of Ground Truth Used

• Clinical Efficacy Study: Self-reported allergic rhinitis symptoms by subjects, as observed during a double-blind, crossover study.
• Safety Testing: Observational data (no reported adverse effects) and laboratory toxicological standards/findings.
• Bench Test: Mold spore counting (presumably objective measurement).

8. The Sample Size for the Training Set

• This concept is not applicable as the device is a physical product (gel) and does not involve a machine learning model or algorithm with a "training set."

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

• This concept is not applicable for the same reason as above.

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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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