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510(k) Data Aggregation
(212 days)
The disposable medical surgical masks are 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 as sterile and non-sterile.
The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.
The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask. This type of device is a physical product and not an AI/ML software device. Therefore, the questions regarding AI/ML specific criteria (such as training sets, ground truth establishment methods, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The document details the acceptance criteria and a study proving the device meets these criteria for a medical mask. The study focuses on bench testing and biocompatibility testing, which are standard for physical medical devices of this type.
Here’s the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology (standard) | Purpose | Acceptance Criteria | Results (for both sterile and non-sterile masks, as they show very similar results in the combined summary table) |
|---|---|---|---|
| ASTM F 1862-17 | Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | Lot 1# pass at 160mmHg;Lot 2# pass at 160mmHg;Lot 3# pass at 160mmHg |
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | Lot 1# 99.6%-99.9%;Lot 2# 99.7%-99.9%;Lot 3# 99.6%-99.9% |
| EN 14683: 2019 | Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | Lot 1# 4.0-5.2;Lot 2# 4.4-5.4;Lot 3# 3.6-5.2 |
| ASTM F2299-2007 | Particulate Filtration Efficiency Performance | ≥ 98% | Lot 1# 98.0%-98.9%;Lot 2# 98.3%-98.9%;Lot 3# 98.3%-98.9% |
| 16 CFR Part 1610 | Flammability | Class I | Lot 1# Class I;Lot 2# Class I;Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device was non-cytotoxic |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, the subject device was non-sensitizing |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, the subject device was non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F 1862-17): The acceptance criteria states "29 out of 32 pass at 160 mmHg," indicating a sample size of 32 units tested. The results are reported for three different lots (Lot 1#, Lot 2#, Lot 3#), suggesting batch testing.
- Other tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability): While specific sample sizes for these tests are not explicitly stated in the summary table, results are provided for three different "lots" (Lot 1#, Lot 2#, Lot 3#). This implies multiple samples were taken from each lot and tested to derive the reported ranges.
- Biocompatibility tests (Cytotoxicity, Sensitization, Irritation): The results are reported as meeting the criteria "Under the conditions of the study," without specific sample numbers mentioned in the summary, but these are standard lab tests typically conducted on a sufficient number of samples as per the ISO standards.
- Data Provenance: The tests were conducted by Chongqing COE Display Technology Co., Ltd. (China). The data is prospective as it's generated specifically for this 510(k) submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical medical device (surgical mask), not an AI/ML diagnostic tool. Ground truth is established through standardized laboratory testing protocols (e.g., ASTM, ISO) and physical measurements/observations, not human expert interpretation of images or data.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, testing involves objective laboratory measurements and adherence to pre-defined standard protocols, not human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. MRMC studies are relevant for diagnostic devices where human readers interpret medical data (e.g., images). This device is a physical protective barrier, and its effectiveness is determined through quantifiable physical and biological barrier properties, not diagnostic accuracy by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm or software device. Its performance is intrinsic to the device's material and design, measured in a laboratory setting.
7. The Type of Ground Truth Used
The ground truth for this device is based on objective, measurable performance criteria derived from recognized national and international standards for medical face masks and biocompatibility:
- Standardized Bench Test Measurements: e.g., Fluid Resistance (ASTM F1862), Bacterial Filtration Efficiency (ASTM F2101), Particulate Filtration Efficiency (ASTM F2299), Differential Pressure (EN 14683), Flammability (16 CFR Part 1610).
- Biocompatibility Lab Results: e.g., Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10). These involve established biological testing methods.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.
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