(270 days)
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.
§ 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).