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510(k) Data Aggregation
(418 days)
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.
Pediatric face masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. The mask is available in the following product sizes: Regular Size (14.5x9cm) and Extra Small Size (12.5x8cm). The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. The masks (both sizes) have decorative patterns, printed with colored inks.
This document describes the performance testing for the Dukal Level 1 Pediatric Face Mask. The device is a medical face mask and the acceptance criteria and performance are based on established standards for such devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared to the requirements specified by various test standards, primarily ASTM F2100-19 Level 1 requirements for medical face masks.
| Test Item | Test Standard Methods | Test Requirements | Subject Device Dukal Level 1 Pediatric Face Masks (meets ASTM F2100-19 Level 1 requirements) | Remark |
|---|---|---|---|---|
| Bacterial Filtration Efficiency Performance (BFE) (%) | ASTM F2101 | ≥95% | >99% | Meets requirement |
| Particulate Filtration Efficiency Performance (PFE) (%) | ASTM F2299 | ≥95% | >99% | Meets requirement |
| Differential Pressure (Delta-P) (mm H2O/cm²) | EN 14683 | <5.0 | ≤3.1mmH2O/cm² | Meets requirement |
| Fluid Resistance Performance (mmHg) | ASTM F1862 | 80 mmHg | Passed at 80 mmHg | Meets requirement |
| Flammability | 16 CFR part 1610 | Class I No Flame Spread | Class I No Flame Spread | Meets requirement |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | - Under the conditions of the study, the device does not show cytotoxicity potential.- Under the conditions of the study, the irritation response category of the device is classified as Negligible.- Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. | - Under the conditions of the study, the device did not show cytotoxicity potential.- Under the conditions of the study, the irritation response category of the device was classified as Negligible.- Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Meets requirement |
| Mechanical Hazards (Small parts, sharp edges, and sharp points) | ASTM F963-17 (sec. 4.6, 4.7, and 4.9), 16 CFR Part 1500, 16 CFR Part 1501 | Pass under requirements for CPSIA Section 106 ASTM F963-17 Mechanical Hazards: under As received, Normal Use, Impact, Torque, and Tension conditions | Pass | Meets requirement |
| Total Lead Content Analysis | CPSC-CH-E1002-08.3 & CPSC-CH-E1001-08.3 | Each accessible component shall not contain more than 100 ppm of lead in children's products. | Pass | Meets requirement |
| Phthalate Analysis | CPSC-CH-C1001-09.4 | Children's toy or child care article does not contain phthalate concentrations of more than 0.1 percent (1000 ppm) in plasticized components. | Pass | Meets requirement |
| Safety of Toys – Migration of certain elements | EN 71-3 | The migration of elements from toy materials shall not exceed the limits for restricted elements. | Pass | Meets requirement |
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 BFE). However, the testing conducted is standard for medical devices and typically follows the sample size requirements prescribed by the referenced ASTM, ISO, EN, and CFR standards.
The data provenance is from non-clinical testing conducted according to recognized international and US standards. The data is prospective in the sense that the tests were performed specifically for this device to assess its performance against predefined criteria. The location of the testing is not specified, but these are generally conducted by certified third-party laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is for a medical face mask, and "ground truth" as typically defined for AI/ML models (e.g., expert consensus on medical images) is not applicable here. The "ground truth" for the test set is established by the specified performance requirements of the referenced international and national standards (ASTM, ISO, EN, CFR). These standards are developed by committees of experts in relevant fields (materials science, microbiology, toxicology, engineering, etc.).
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and yield quantitative results against pre-defined thresholds. There is no human interpretation or adjudication in the traditional sense of medical image analysis for AI/ML.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, typically involving medical imaging. This submission concerns a physical medical device (face mask) and its material properties and safety, not an AI/ML diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense. The performance tests reported are for the device itself ("algorithm only" performance in a metaphorical sense), independent of human use or interpretation during the test. The tests measure the intrinsic properties of the mask.
7. The Type of Ground Truth Used
The ground truth used is the performance specifications and safety limits defined by established industry and regulatory standards (e.g., ASTM F2100-19 for masks, ISO 10993 for biocompatibility, etc.). These standards are based on scientific evidence and consensus among experts to ensure the safety and efficacy of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product whose performance is assessed through laboratory testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is not an AI/ML device.
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