(88 days)
eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvel/comforters.
eVENT™ Allergen Barriers consist of mattress, pillow and duvet/comforter encasings. The products consist of an expanded PTFE membrane laminated to a synthetic or synthetic/natural combination fabric. The expanded PTFE membrane provides a moisture-vapor & air permeable ("breathable") barrier with pores too small to allow passage to either house dust mites or their allergen containing fecal droppings. The fabric component provides a strong, easily maintained support for the ePTFE membrane. EVENT™ Allergen Barrlers are soft, comfortable and easy to clean; They are simply damp-dusted when the bed sheets are changed. Allergydirect.com's membrane manufacturing process is sufficiently controlled to ensure uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens. The membrane's vapor permeable characteristics help promote sleeping comfort. Thus, eVENT™ Allergen Barriers serve as an effective barrier between a patient and a cause of their allergies; this results in a healthier, more comfortable sleeping environment.
The acceptance criteria and study proving meeting those criteria for the eVENT™ Allergen Barriers are described below, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Allergen Barrier Effectiveness | Pore size too small to allow passage of house dust mites or their allergen-containing fecal droppings. | "membrane's vapor permeable characteristics help promote sleeping comfort. Thus, eVENT™ Allergen Barriers serve as an effective barrier between a patient and a cause of their allergies; this results in a healthier, more comfortable sleeping environment." and "Laboratory tests demonstrate eVENT™ Allergen Barriers' ability to serve as a barrier to house dust mites and their fecal matter." |
| Breathability / Comfort | More "breathable" than comparable predicate devices to promote sleeping comfort. | "eVENT™ Allergen Barriers are over 2 times (Modified Desiccant Method [MDM] dry method) more 'breathable' than the comparable Allergy Control Products' ACb™ Elite and over 4 times more 'breathable' than Allergy Control Products' ACb™ Sheer." |
| Durability / Support | Fabric component provides strong support for the ePTFE membrane. | "The fabric component provides a strong, easily maintained support for the ePTFE membrane." |
| Maintainability | Easily cleaned and maintained. | "eVENT™ Allergen Barrlers are easily maintained, requiring only damp dusting when the bed sheets are changed." and "Additional testing demonstrates eVENT™ Allergen Barrier's strength, softness and ease of cleaning." |
| Softness / Comfort | Soft and comfortable. | "eVENT™ Allergen Barrlers are soft, comfortable and easy to clean" and "softness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. It mentions "Laboratory tests" and "Additional testing" without detailing the number of units tested.
The data provenance is not explicitly stated. Given that the submission is to the FDA for a US market, it is likely the testing was conducted in a controlled laboratory environment. The nature of the tests (material properties) suggests these were likely prospective, controlled laboratory tests rather than retrospective or prospective clinical data from human subjects.
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. The tests described are primarily material property tests (e.g., breathability, pore size inference, strength), which typically rely on standardized laboratory methods rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As mentioned above, the tests are primarily objective material property measurements, not requiring adjudication of subjective interpretations.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an allergen barrier, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product (allergen barrier), not an algorithm or software.
7. The Type of Ground Truth Used
The ground truth used for demonstrating device performance appears to be:
- Direct measurement of material properties: For "breathability," the "Modified Desiccant Method (MDM) dry method" was used.
- Inferred physiological effect based on physical properties: The barrier effectiveness against dust mites and their fecal matter is based on the controlled manufacturing process to ensure "uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens." This implies physical measurement of pore size or validation that the pore size effectively blocks the allergens.
- Performance against established standards/comparable devices: The breathability was compared directly to "comparable Allergy Control Products' ACb™ Elite and over 4 times more 'breathable' than Allergy Control Products' ACb™ Sheer."
- Qualitative assessment of physical characteristics: Softness, comfort, and ease of cleaning were likely assessed through testing that demonstrated these attributes, although specific methods are not detailed.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical product, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the device is a physical product, not a machine learning model.
§ 880.6190 Mattress cover for medical purposes.
(a)
Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.