(251 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Significant reduction in daily symptoms of hay fever (Total TNSS). | Rhinix™ significantly reduced daily symptoms of hay fever as measured by total TNSS (p=0.049). |
| Significant reduction in specific symptoms (Sneezing, itching, rhinorrhea, throat irritation). | Sneezing, itching, rhinorrhea, and throat irritation were also significantly reduced compared to placebo. |
| No significant perception of increased nasal resistance compared to placebo. | There was no difference in perception of increased nasal resistance when wearing Rhinix™ compared to a placebo device. |
| Safety of use. | The study indicated that a Rhinix™ Nasal Filter is safe to use. |
| Allows unimpeded breathing. | Rhinix™ could thus be considered to allow unimpeded breathing (based on no perceived increase in nasal resistance compared to placebo). |
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.
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).