(262 days)
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue
Here's a breakdown of the acceptance criteria and study information for the Epard Protective Products Surgical Face Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Predicate Results (K022256) | Acceptance Criteria (New Device) | New Device Performance | Passes/Fails |
|---|---|---|---|---|---|
| Fluid Resistance (mmHg) | ASTM F 1862 | No visual detection of penetration | Passed | No visual detection of penetration | Passes |
| Particulate Filtration Efficiency (%) (0.1um) | ASTM F2299 | 2.0 microns | 98.7% | N/A (implied >= 98.7%) | Passes |
| Bacterial Filtration Efficiency (%) | ASTM F2101-01 | 97.9% | 99.9% | N/A (implied >= 99.9%) | Passes |
| Differential Pressure (Delta-P) (mm H2O/cm2) | Mil- M369454C | 1.8 | 2.0 - 2.5 | N/A (implied 2.0-2.5) | Passes |
| Flammability Class | 16 CFR 1610 | 2 | Classified as Class I | N/A (implied Class I) | Passes |
Notes on the Table:
- "N/A (implied)": The document states "Equivalence is demonstrated through intended use, materials, design and testing methods" and "no significant differences between the application device and the predicate." For performance characteristics where the predicate result is given as the "Acceptance Criteria or Results" for the new device, this implies the new device met or exceeded these values. The document doesn't explicitly list the new device's numerical performance for each criterion but rather indicates it passed against the established criteria, which are the predicate's results for some metrics.
- "Passed": For Fluid Resistance, the predicate's result was "No visual detection of penetration," and this was also the acceptance criteria for the new device, which it passed.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are standard ASTM and military specifications, implying laboratory testing. The submission is from Epard Protective Products, Ltd. in Hubei, China, so the testing was likely conducted by or contracted by this manufacturer, possibly in China or a certified testing facility elsewhere. The nature of the performance tests suggests individual product testing, rather than human data that would be classified as retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the nature of the device (surgical face mask) and the performance criteria (fluid resistance, filtration efficiency, differential pressure, flammability), the "ground truth" is established through objective laboratory testing according to standardized protocols (ASTM, Mil-Spec, CFR).
Therefore, no human experts were used to establish ground truth in the way one might for diagnostic imaging interpretation. The "ground truth" is the result derived from the physical testing methods themselves.
4. Adjudication Method for the Test Set
As the "ground truth" is established through objective, standardized physical testing rather than human interpretation, no adjudication method (like 2+1 or 3+1 consensus) was applicable or used. The test results are quantitative or qualitative (e.g., "no visual detection") outcomes of the laboratory procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was mentioned or conducted. This type of study is typically relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved in assessing cases. Surgical face masks are passive protective equipment, and their performance is evaluated through material science and physical property testing, not through human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to a surgical face mask. Standalone performance studies refer to the performance of an algorithm or AI without human involvement, common in AI-powered diagnostic tools. A surgical face mask is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and observations derived from standardized laboratory performance tests. These are:
- Quantitative measurements: Percentage for filtration efficiency, mm H2O/cm2 for differential pressure.
- Qualitative observation: "No visual penetration" for fluid resistance.
- Classification: "Flammability Class."
This is akin to laboratory/physical property ground truth.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described evaluates the manufactured product's inherent physical properties against established standards.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a surgical face mask.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.