Search Results
Found 1 results
510(k) Data Aggregation
(454 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
The provided document is a 510(k) summary for a surgical face mask (K203161), demonstrating substantial equivalence to a predicate device (K202061). This type of regulatory submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and material comparisons. It does not contain information about a study involving human readers or AI assistance. Therefore, I will focus on the performance criteria and the non-clinical studies conducted for this device.
Here's the breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method | Acceptance Criteria | Reported Device Performance (Subject Device - 3 Lots) |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 (Resistance of Surgical face masks to penetration by synthetic blood) | (A) There are no burn times; or (B) There is only one burn time and it is equal to or greater than 3.5 seconds; or (C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. For the purpose of comparison to predicate, the reported criteria is 80 mmHg. | Lot 1: 32 Out of 32 pass at 80 mmHgLot 2: 32 Out of 32 pass at 80 mmHgLot 3: 32 Out of 32 pass at 80 mmHg |
| Particulate Filtration Efficiency (%) | ASTM F2299 (Initial Efficiency of Materials to Penetration by Particulates) | ≥ 95% | Lot 1: Average 96.6%Lot 2: Average 96.1%Lot 3: Average 96.2% |
| Bacterial Filtration Efficiency (%) | ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE)) | ≥ 95% | Lot 1: Average 99.5%Lot 2: Average 99.4%Lot 3: Average 99.4% |
| Flammability Class | 16 CFR 1610 (STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES) | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
| Differential Pressure (Delta-P) (mm H2O/cm²) | ASTM F2100-19 / EN 14683:2019+AC (2019)(E), Annex C (Determine breathing resistance) | < 5.0 mmH2O/cm² | Lot 1: Average 3.9 mmH2O/cm²Lot 2: Average 3.8 mmH2O/cm²Lot 3: Average 4.0 mmH2O/cm² |
| In Vitro Cytotoxicity | ISO 10993-5: 2009 (MTT method) | Viability reduced to <70% of the blank indicates cytotoxic potential. The test article should have at least the same or a higher viability than the 100% extract. | Non-cytotoxic |
| Skin Sensitization | ISO 10993-10:2010 (Guinea Pig Maximization) | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. | Non-sensitizing |
| Skin Irritation | ISO 10993-10:2010 (Skin Irritation Test) | Primary irritation index for the test article should demonstrate non-irritation when compared to controls. | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Testing: The document states that "three lots of product" were tested for the physical performance criteria (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Flammability, Differential Pressure). Specific sample sizes per lot for each test are not explicitly stated, but for Fluid Resistance, it mentions "32 Out of 32 pass" for each lot, indicating a sample size of 32 for that specific test within each lot.
- Biocompatibility Testing:
- In Vitro Cytotoxicity: The specific number of samples (e.g., cell cultures, extracts) tested is not detailed, but it's implied by "the test article" and "the 100% extract."
- Skin Sensitization (Guinea Pig Maximization): This method inherently uses animal cohorts (guinea pigs). The exact number of animals in the test group and control group is not specified in the provided text.
- Skin Irritation: This test also uses animal cohorts. The document mentions "individual animals" and "number of animals" for calculating scores, but the specific count is not provided.
- Data Provenance: The document does not specify the country of origin of the data for these tests or whether they were retrospective or prospective. Given that the manufacturer is in Wuhan, China, and the submission is to the FDA, the testing would likely have been conducted in accredited labs, potentially in China or elsewhere, to internationally recognized standards. All tests are inherently prospective in nature as they involve testing newly manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The studies performed are non-clinical, laboratory bench tests and biological evaluations, not studies involving human perception or interpretation (like radiology image analysis). Therefore, there is no "ground truth" established by experts in the context of clinical interpretation, but rather by standardized laboratory procedures and measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required (e.g., blinded reads, pathology reviews). The tests described are objective, standardized laboratory measurements.
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This document is for a physical medical device (surgical face mask), not an AI/software as a medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical face mask, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is established by objective, standardized laboratory measurements according to the specified ASTM, EN, and ISO standards.
- For Fluid Resistance, Particulate Filtration, Bacterial Filtration, Flammability, and Differential Pressure, the ground truth is the quantitative measurement obtained through the defined test method (e.g., percentage efficiency, pressure drop, burn class, pass/fail at a specific mmHg).
- For Biocompatibility (Cytotoxicity, Sensitization, Irritation), the ground truth is the biological response observed and quantified (e.g., cell viability, skin reactions/grades) according to ISO standards, which determines if the material is non-cytotoxic, non-sensitizing, and non-irritating.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical device being evaluated for safety and performance through direct testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
Ask a specific question about this device
Page 1 of 1