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510(k) Data Aggregation
(100 days)
The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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 non-sterile.
The proposed device is a three-layers, flat-pleated mask. Its size is 17.5 cm x 9.5 cm, and it is available in two types, Ear-loop and Tie-On. Both the ear loop and tie-on masks are available in three barrier levels (Level 1, Level 3) based on ASTM F2100: 2019. The mask body is composed of three layers which is made of PP non-woven cloth. The difference between the three levels mask is the density of middle material. The ear loop or tie strings is used to secure the mask over the users' mouth and face. The nosepiece provides a firm fit over the nose. Ear loops are made of Nylon and spandex, and tie strings are made of PP non-woven cloth. The nose clip is made of Aluminum wire.
The provided text is a 510(k) summary for a Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask. It describes the device, its intended use, and comparative testing against a predicate device (K160269) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Device Performance
The device acceptance criteria are based on established standards for medical face masks, primarily ASTM F2100:2019, as well as standards for flammability and biocompatibility (ISO 10993 series). The performance of the proposed device is compared against these criteria and the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive table (Table 2: Summary of Non-clinical Testing) outlining the test methodology, purpose, acceptance criteria, and results for the proposed device, categorized by three levels of performance (Level 1, Level 2, Level 3).
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M: 2017) | To evaluate effectiveness against exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | Level 1: Pass at 80mmHgLevel 2: Pass at 120mmHgLevel 3: Pass at 160mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | To determine the particle filtration efficiency of the test article. | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Pass at 98.2% (Level 1)Pass at 99.3% (Level 2)Pass at 99.6% (Level 3) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101: 2019) | To determine the bacterial filtration efficiency of the test article using a biological aerosol of Staphylococcus aureus. | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Pass at 98.9% (Level 1)Pass at 99.4% (Level 2)Pass at 99.6% (Level 3) |
| Differential Pressure (EN 14683:2019+AC: 2019 Annex C) | To measure the breathability of the mask. | Level 1: <5.0 mmH2O/cm²Level 2: <6.0 mmH2O/cm²Level 3: <6.0 mmH2O/cm² | Pass at 3.6 mmH2O/cm² (Level 1)Pass at 4.0 mmH2O/cm² (Level 2)Pass at 4.6 mmH2O/cm² (Level 3) |
| Flammability (16 CFR Part 1610) | To assess the flammability of the mask material. | Class 1 (lowest flammability) | Class 1 |
| Cytotoxicity (ISO 10993-5: 2009) | To evaluate the in vitro cytotoxicity of the test sample. | Viability ≥70% of blank; 50% extract of test sample should have at least the same or higher viability than 100% extract. | Viability ≥70% of blank; 50% extract had higher viability than 100% extract. Device was non-cytotoxic. |
| Sensitization (ISO 10993-10: 2010) | To evaluate the sensitization potential of the test sample for skin irritation. | Non-sensitizing | Device was non-sensitizing. |
| Irritation (ISO 10993-10: 2010) | To evaluate the irritation potential of the test sample for skin irritation. | Non-irritating | Device was non-irritating. |
Study Proving Device Meets Acceptance Criteria
The study performed is a series of non-clinical, laboratory-based physical and biological performance tests.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Nonclinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results from three nonconsecutive lots of 32 samples per lots (total of 96 samples) for each level claimed below demonstrated that the proposed device complies with the following standards."
- This means for each of the three levels (Level 1, Level 2, Level 3) of masks, 96 samples were tested. Thus, a total of 96 * 3 = 288 samples were tested across all levels for the performance and biocompatibility tests.
- Data Provenance: The document does not explicitly state the country of origin where the tests themselves were conducted, but the sponsor and designated submission correspondent are based in China. The study is retrospective, as it involves testing completed products against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For medical face masks, ground truth is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards), rather than expert consensus on individual "cases" or interpretations. The results are quantitative measurements or pass/fail determinations based on predefined acceptance criteria.
4. Adjudication Method for the Test Set:
- None. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiologists reading images) where disagreement or subjective assessment might occur. In this context of laboratory performance testing, the results are objective measurements against set criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is not relevant here as the device is a medical face mask, not an AI-powered diagnostic tool, and the evaluation is based on physical and biological performance, not human reader interpretation (with or without AI assistance).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, by definition, these are standalone tests. The tests performed (fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, biocompatibility) are all laboratory tests assessing the intrinsic properties and performance of the mask materials and construction. There is no "human-in-the-loop" component in the testing methodology itself beyond conducting the standardized procedures.
7. The Type of Ground Truth Used:
- Standardized Laboratory Test Results and Regulatory Standards/Acceptance Criteria. The ground truth for this device is based on the quantitative and qualitative outcomes of the physical and biological tests as defined by recognized national and international standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility, 16 CFR Part 1610 for flammability). The device "meets acceptance criteria" if its measured performance falls within the specified ranges or passes the qualitative thresholds set by these standards.
8. The Sample Size for the Training Set:
- Not Applicable. This device is a manufactured product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The consistency and quality of the production are assured through manufacturing controls and testing samples from production lots.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device. The "ground truth" for ensuring the quality of the manufactured product is adherence to the established material specifications, manufacturing processes, and final product testing against the performance standards, validated with samples from production lots.
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