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510(k) Data Aggregation
(34 days)
The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.
The subject device is three-layers, flat-pleated masks constructed of nonwoven polypropylene materials, the inner and outer layers are made of polypropylene nonwoven, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A polypropylene wire nose piece is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable devices, provided non-sterile.
This document describes non-clinical performance and biocompatibility testing for the D-Care Surgical Face Mask 3 Ply and D-Care Medical Face Mask 3 Ply.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance | ≥29 out of 32 passed in 160 mmHg (Level 3) | ≥29 out of 32 passed in 160 mmHg (Level 3) |
| Particulate Filtration | ≥98% at 0.1µm | ≥99% at 0.1µm |
| Bacterial Filtration | ≥98% | ≥99% |
| Differential Pressure | < 6.0 mm H2O/cm² | < 4 mmH2O/cm² |
| Flammability | Class 1 (≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) |
| Cytotoxicity | The device is non-cytotoxic | Under the conditions of the studies, the device is non-cytotoxic |
| Skin Sensitization | The device is non-sensitizing | Under the conditions of the studies, the subject device is non-sensitizing |
| Skin Irritation | The device is non-irritating | Under the conditions of the studies, the device is non-irritating |
2. Sample size used for the test set and the data provenance
- Fluid Resistance (ASTM F1862): At least 32 samples (implied from "≥29 out of 32 passed").
- Other Performance Characteristics (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The document states that performance testing was performed on "three non-consecutive lots" and that the "Sample size of each lot is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%." The exact sample size per lot per test is not explicitly stated, but it follows the ISO 2859-1 standard.
- Biocompatibility (Cytotoxicity, Skin Sensitization, Skin Irritation): The sample size for biocompatibility testing is not explicitly stated in this document.
- Data Provenance: The tests were conducted by the manufacturer, DANAMECO MEDICAL JOINT STOCK CORPORATION, based in Vietnam. The studies are non-clinical, likely laboratory-based. The document does not specify if the studies were retrospective or prospective, but given they are manufacturing tests for a new device, they are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance characteristics and biocompatibility testing for a medical device (surgical face mask). The "ground truth" in this context is established by adherence to recognized international standards (e.g., ASTM, ISO, CFR) and regulatory requirements, not through expert consensus on medical images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" as understood in imaging or clinical studies does not directly apply here. The results are objective measurements from laboratory tests.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements based on specified testing standards and acceptance criteria. There is no subjective interpretation requiring an adjudication method.
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-based device, nor a diagnostic device that would typically involve human readers. It is a surgical face mask evaluated for its physical and biological performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/algorithm-based device.
7. The type of ground truth used
The ground truth is established by:
- Objective measurement against recognized industry standards: ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR 1610, ISO 10993-5, ISO 10993-10.
- Pre-defined acceptance criteria: These criteria are derived from regulatory guidance and standards (e.g., FDA recommendations, ASTM F2100 at level 3 for surgical masks).
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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