(229 days)
The Surgical Face Mask of different colors (Blue, White, and Green) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of bacteria, body fluid and particulate material. This Surgical Face Mask is non-sterilized and disposable.
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops. The nosepiece for all Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are malleable aluminum wire. All the materials used in the construction of the Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are being used in currently marked devices.
The Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop (K123115) demonstrates substantial equivalence to the predicate device, Modern Healthcare Corp. Surgical Face Mask (K063043), through a series of non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Predicate Device K063043) | Reported Device Performance (ACME Filter Mask Inc. K123115) |
|---|---|---|
| Similarity | ||
| Fluid Resistance | Fluid Resistance | Fluid Resistance |
| Flammability Class | Class I (No Flame Spread) | Class I (No Flame Spread) |
| Regulatory Class | Class II (ASTM2100-04 Low Barrier) | Class II |
| BFE (%) (Bacterial Filtration Efficiency) | Higher than 99% | Higher than 99.9% |
| Difference | ||
| Type (of mask fastening) | Tie-on and Ear-loop (Green, White, Blue, Pink) | Ear-Loop (Green, White, Blue) |
| Delta-P (Air Exchange Pressure) | Average 2.6 $mmH_2O/cm^2$ | Average 3.33 $mmH_2O/cm^2$ for Air Exchange Pressure |
| Particulate Filtration Efficiency Performance (%) | Average 96.8% at 0.1 micron (for general particulate filtration) | Average 94.79% for Solid Aerosol Filtration Efficiency; More than 99.5% for Viral Filtration Efficiency |
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, Delta-P, etc.). The provenance of the data is from non-clinical bench testing performed by Acme Filter Mask Inc. The country of origin for the testing is implied to be Taiwan, R.O.C. where the submitter is located. The study is a retrospective comparison against established standards and a predicate device.
3. Number of Experts and Qualifications for Ground Truth:
This document describes a non-clinical device safety and effectiveness evaluation based on standardized testing. There is no mention of experts being used to establish a "ground truth" in the context of clinical interpretation, as this is a physical product performance assessment. The ground truth for these tests is defined by the technical specifications and performance criteria outlined in the referenced ASTM, MIL, and CFR standards.
4. Adjudication Method for the Test Set:
Not applicable. This is a non-clinical performance study against predefined standards and a predicate device's performance, not a study involving human interpretation or adjudication of results in a clinical setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a surgical face mask, and its evaluation focuses on physical performance characteristics rather than diagnostic or interpretative accuracy that would involve human readers.
6. Standalone Performance:
Yes, a standalone performance assessment was done. The reported performance metrics (BFE, Delta-P, Particulate Filtration Efficiency, Fluid Resistance, Flammability, Biocompatibility) are direct measurements of the device's physical properties and its ability to meet specific standards, independent of human interaction during use. These are "algorithm only" in the sense that they represent the intrinsic performance of the manufactured product.
7. Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on standardized test methods and acceptance criteria. These include:
- ASTM F1862-05 for Fluid Resistance
- ASTM F2101-01 for Bacterial Filtration Efficiency (BFE)
- ASTM F1215 for Particulate Filtration Efficiency (latex Particle challenge)
- MIL M 36954 C for Differential Pressure (Delta-P)
- 16CFR 1610 for Flammability
- ISO 10993-5 /-10 for Biocompatibility
The "truth" is whether the device's performance meets or exceeds the specified thresholds in these well-established industry standards and compares favorably to the predicate device.
8. Sample Size for the Training Set:
Not applicable. This is a physical product performance evaluation against standards, not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used.
§ 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.