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510(k) Data Aggregation
(189 days)
The Disposable medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Disposable Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric with blue color. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric with white color. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for a Disposable Medical Face Mask. It outlines the device's characteristics, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Based on the provided information, I can answer some of your questions, but many of the specific details you requested (especially regarding AI/ML models, expert ground truth, and human reader studies) are not applicable as this document pertains to a physical medical device (a face mask) and not a software-based diagnostic or AI-powered system.
Here's the breakdown:
Acceptance Criteria and Device Performance (for a Medical Face Mask)
The acceptance criteria are essentially the performance requirements for medical face masks as defined by the listed ASTM and EN standards. The "device performance" is whether the mask meets these criteria.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (typically from ASTM F2100-19 for Medical Face Masks) | Reported Device Performance (Proposed Device K202628) | Predicate Device Performance (K173062) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass at 120mmHg (Level 1, 2 or 3) | Pass at 120mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% (Level 2 or 3) | ≥98% | Average 99.4% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥98% (Level 2 or 3 for 0.1µm particles) | ≥98% | Average 99.74% at 0.1µm |
| Differential Pressure (Delta P) (EN 14683) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Average 2.7 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 (non-flammable) | Class 1 non-flammable | Class 1 non-flammable |
| Biocompatibility (ISO 10993 series) | Non-cytotoxic, non-irritating, non-sensitizing | Confirm to requirements of ISO 10993 series standards (non-cytotoxic, non-irritating, non-sensitizing) | Confirm to requirements of ISO 10993 series standards (non-cytotoxic, non-irritating, non-sensitizing) |
Study Proving Device Meets Acceptance Criteria:
The study refers to the non-clinical testing conducted.
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of mask samples tested for each criterion (e.g., how many masks were tested for BFE). This level of detail is typically in the test reports, which are not part of this summary.
- Data Provenance: The tests were conducted by the manufacturer, Qinghai Zhong Dao Win-win Medical Protective Equipment Co., Ltd. The country of origin for the data is China, as this is where the manufacturer is based and presumably where the testing was performed. The data is prospective in the sense that the tests were performed on newly manufactured devices specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device (mask), not an AI/ML model for image analysis or diagnosis. The "ground truth" is established by direct physical or biological testing against a standard, not by expert consensus on observational data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, the "truth" is determined by standardized test procedures and measurements, not by expert adjudication of 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:
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. The performance metrics are "standalone" in that they are direct measurements of the mask's physical and biological filtration properties.
7. The type of ground truth used:
- Analytical/Empirical Data derived from Standardized Test Methods: The "ground truth" for the mask's performance (e.g., BFE, PFE, fluid resistance) is the result obtained from specific, validated laboratory test methods (e.g., ASTM F2101 for BFE, ASTM F1862 for fluid resistance). These methods have defined procedures and measurement techniques to determine the mask's properties.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used for this type of device.
In summary, the document describes a successful 510(k) submission for a disposable medical face mask, demonstrating its substantial equivalence to a legally marketed predicate device through a series of non-clinical, standardized performance tests. The concepts of AI/ML model evaluation, expert ground truth, and human reader studies are entirely outside the scope of this particular device's regulatory review.
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