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510(k) Data Aggregation
(74 days)
The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
The AIC Disposable Medical Masks are Blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
This document is a 510(k) Summary for a disposable medical mask, not an AI-powered medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training sets is not applicable to this type of submission.
However, I can extract the relevant non-clinical performance data and the acceptance criteria for those tests, as this is how the device's performance is proven to meet the required standards for a medical mask.
Here's the breakdown based on the provided document, addressing what is applicable:
Device: AIC Disposable Medical Mask
Device Type: Surgical Apparel (Class II Medical Device)
Purpose of the Study: To demonstrate substantial equivalence to a legally marketed predicate device (K153496) by showing that the AIC Disposable Medical Mask is as safe and effective as the predicate device. This is primarily done through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for medical masks are based on recognized standards (e.g., ASTM F2100). The document specifically details the performance against ASTM Level 3 requirements.
| Test Item | Test Standard/Method | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Average) | Conclusion |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥ 98% | 99.3% | Pass |
| Differential Pressure (Delta-P) | ASTM F2100-19 | < 6 mm H₂O/cm² | 4.40 mm H₂O/cm² | Pass |
| Fluid Resistance Performance | ASTM F1862 | Pass at 160 mmHg | 96 out of 96 Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥ 98% | 99.9% | Pass |
| Flammability | 16 CFR 1610 | Class 1 (≥ 3.5 seconds) | Test Article ignited, but extinguished or did not ignite. (This phrasing usually implies Class 1) | Pass |
Biocompatibility Testing (Acceptance Criteria are implied non-toxicity/irritation/sensitization)
| Test Name | Standard Followed | Result |
|---|---|---|
| Cytotoxicity | ISO10993-5 | Under the conditions of the study, the proposed device extract demonstrated evidence of potential cytotoxicity. (Note: This finding necessitated further testing, which resolved the concern.) |
| Skin Irritation | ISO10993-10 | Under the conditions of the study, the proposed device extract was determined to be non - irritating |
| Skin Sensitization | ISO10993-10 | Under the conditions of the study, the proposed device extract was determined to be non - sensitizing |
| Acute Toxicity | ISO10993-11 | Under the conditions of the study, the proposed device extract was determined to be non-toxic. (Conducted to address the initial cytotoxicity finding, and confirmed biocompatibility.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Bacterial filtration efficiency, Differential pressure, Fluid Resistance Performance, Particulate Filtration Efficiency, Flammability), the sample size was specified as 3 lots, with 32 samples per lot, totaling 96 samples per test. For Fluid Resistance, the outcome was reported for "96 out of 96."
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed, but the applicant (The Aleen International Corporation) is based in Heyuan, Guangdong, China. The data is retrospective in the sense that it was collected as part of the premarket submission based on standard laboratory testing of the manufactured product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. For non-clinical performance testing of medical masks, "ground truth" is established by laboratory measurement against established engineering and material standards (e.g., ASTM, ISO). It does not involve human expert interpretation of images or other data which would require expert consensus.
4. Adjudication Method for the Test Set
Not Applicable. As per point 3, the ground truth is established by objective laboratory measurements and does not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is relevant for AI-powered diagnostic devices where human readers interpret medical images. This document is for a physical medical mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm. Its performance is measured directly by physical and biological testing.
7. The Type of Ground Truth Used
The ground truth for the performance of the medical mask is based on objective laboratory measurements according to international and national standards (ASTM, ISO, 16 CFR) for:
- Bacterial Filtration Efficiency
- Differential Pressure
- Fluid Resistance
- Particulate Filtration Efficiency
- Flammability
- Biocompatibility (Cytotoxicity, Skin Irritation, Skin Sensitization, Acute Systemic Toxicity)
8. The Sample Size for the Training Set
Not Applicable. This is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As per point 8, there is no AI training set.
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