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510(k) Data Aggregation
(188 days)
The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile.
3-ply EcoGuard B with Earloop, Model Number: ECO01
3-ply EcoGuard B with Tie-on, Model Number: ECO02
The proposed surgical masks are available in two models with three-ply pleated earloop or tie-on (EcoGuard B) masks with ear loops and nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops or ties are held in place over the users' mouth and nose by two elastic ear loops or four ties welded to the surgical mask. Neither the elastic ear loops, nor ties are made with natural rubber latex. The nose piece in the layers of surgical mask is to allow the user to fit the surgical mask around their nose, which is made of malleable polyethylene wire. The surgical masks are sold nonsterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification summary for a surgical mask (EcoGuard B). It assesses the substantial equivalence of the new device to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and biocompatibility testing, not clinical studies involving human patients or complex AI algorithm evaluation.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (EcoGuard B) | Average |
|---|---|---|---|---|
| ASTM F1862 Synthetic Blood Penetration | Determine synthetic blood penetration resistance | Level III (Pass at 160 mmHg) | Pass at 160 mmHg (95/96) (32 samples each from 3 lots) | N/A |
| ASTM F2101 Bacterial Filtration Efficiency | Determine the bacterial filtration efficiency | ≥ 98% | Pass (96/96) (32 samples each from 3 lots) | 99.9% |
| ASTM F2299 Particulate Filtration Efficiency at 0.1 micron | Determine submicron particulate filtration efficiency | ≥ 99% | Pass (96/96) (32 samples each from 3 lots) | 99.8% |
| Mil-M-36954C Delta P (Breathing Resistance) | Determine breathing resistance or differential pressure | < 6.0 mm H2O/cm2 | Pass (96/96) (32 samples each from 3 lots) | 4.4 mm H2O/cm2 |
| 16 CFR 1610 Flammability | Determine flammability or flame spread | Class 1 | Class 1 Pass (96/96) (32 samples each from 3 lots) | N/A |
| Cytotoxicity | Assess cellular toxicity | Noncytotoxic | Pass (device is noncytotoxic) | N/A |
| Irritation | Assess skin irritation | Nonirritating | Pass (device is nonirritating) | N/A |
| Sensitization | Assess allergic sensitization | Nonsensitizing | Pass (device is nonsensitizing) | N/A |
2. Sample sized used for the test set and the data provenance
- Sample Size for performance tests (ASTM F1862, F2101, F2299, Mil-M-36954C, 16 CFR 1610): 32 samples each from 3 non-consecutive lots (Total 96 samples per test).
- Data Provenance: The document does not specify the country of origin where the testing was performed. The data is retrospective as it was collected and analyzed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This document describes non-clinical performance and biocompatibility testing for a surgical mask, not clinical studies requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for these tests are objective measurements based on specified industry standards.
4. Adjudication method for the test set
N/A. This is not applicable to the non-clinical and biocompatibility testing described.
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
N/A. This document pertains to a medical mask, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI algorithm. The performance tests are for the physical properties of the mask.
7. The type of ground truth used
The ground truth for the performance tests (e.g., filtration efficiency, blood resistance) are established and defined by the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and other referenced standards (ASTM F1862, F2101, F2299, Mil-M-36954C, 16 CFR 1610). For biocompatibility, the ground truth is determined by the results of standardized biological tests (Cytotoxicity, Irritation, Sensitization) against established safety thresholds.
8. The sample size for the training set
N/A. This document describes the testing of a manufactured physical product (surgical mask), not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
N/A. Not applicable for this type of device and testing.
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