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510(k) Data Aggregation
(91 days)
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.
The Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.
All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
Based on the provided text, the device in question is a Surgical Mask, and the submission is a 510(k) premarket notification. This type of submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies for novel AI/ML-driven diagnostics.
Therefore, the requested information regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and standalone algorithm performance is not applicable to this document. This document describes the testing for physical and biological properties of the surgical masks to show they perform as well as a predicate device.
Here's the information that is applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the surgical masks are based on ASTM F2100 Level 2 requirements and other relevant standards.
| ITEM | Acceptance Criteria | Results (Blue Color) | Results (White Color) |
|---|---|---|---|
| Performance Characteristics (ASTM F2100 Level 2 Requirement) | |||
| Fluid Resistance (ASTM F1862) | 120 mmHg | 120 mmHg | 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) at 0.1 micron | ≥ 98% | ≥ 99.30% | ≥ 99.77% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | ≥ 98.54% | ≥ 99.04% |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mm H2O/cm² | < 5.4mm H2O/cm² | < 5.0mm H2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO 10993) | |||
| Cytotoxicity (ISO 10993-5) | No cytotoxicity effect | Under the conditions of the study, no cytotoxicity effect | Under the conditions of the study, no cytotoxicity effect |
| Irritation (ISO 10993-10) | No irritation effect | Under the conditions of the study, no irritation effect | Under the conditions of the study, no irritation effect |
| Sensitization (ISO 10993-10) | No sensitization effect | Under conditions of the study, no sensitization effect | Under conditions of the study, no sensitization effect |
The study proves the device meets the acceptance criteria as indicated by the "Results" columns. All reported values fall within or exceed the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The studies are non-clinical bench tests performed on the physical masks themselves (e.g., measuring filtration efficiency, pressure drop, flammability, and conducting biocompatibility tests).
The provenance of the data is from non-clinical bench testing performed on the devices manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. in China. The tests are reported as "Nonclinical Test Conclusion," implying they were conducted in a laboratory setting to verify the device's design specifications. The studies are prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This concept is not applicable to a submission for surgical masks based on physical and biological performance testing. "Ground truth" in this context refers to the results of standardized laboratory tests performed by qualified personnel using specified methodologies. There is no mention of expert consensus or human interpretation being part of establishing "ground truth" for these performance metrics.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results/labels. The tests are laboratory-based measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (surgical masks).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. Its performance is evaluated through physical and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance characteristics (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and biocompatibility testing (ISO 10993). These are objective, quantitative measurements against predefined criteria.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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