K Number
K212111
Date Cleared
2022-01-23

(201 days)

Product Code
Regulation Number
878.4040
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

Device Description

The Myflon Surgical Mask Level 3 is blue in color, composed of three-layers, a flat-pleated type mask, utilizing ear loops for wearing. The Myflon Surgical Mask Level 3 materials consist of an outer cover (polypropylene spunbond, blue), middle filtration layer (polypropylene, melt-blown, white), and inner cover comfort/support layer web (polypropylene spunbond, white). Each mask has stretchable elastic laminate (Spunbond/elastic film/spunbond bond) ear loops to secure the mask over the user's mouth and nose and includes a polyethylene/ polypropylene coated wire nosepiece to provide a firm fit over the face and nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.

AI/ML Overview

The provided text is a 510(k) summary for a surgical mask (Myflon Surgical Mask Level 3). It details the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing. It does not describe an AI/ML-driven medical device, an algorithm's performance, or any human-in-the-loop studies. Therefore, I cannot extract the information required to answer your specific questions related to AI/ML device acceptance criteria and study details.

The document explicitly states: "No clinical tests were performed." and describes the product as a physical surgical mask, not a software or AI device.

Therefore, I am unable to provide the requested information regarding:

  1. A table of acceptance criteria and reported device performance for an AI/ML device.
  2. Sample size used for the test set and data provenance.
  3. Number of experts and their qualifications for establishing ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study and effect size.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The acceptance criteria and performance data provided in the document pertain to the physical properties of the surgical mask, such as barrier testing (fluid resistance, particle filtration, bacterial filtration), flammability, differential pressure, and biocompatibility.

Here is the table of acceptance criteria and reported device performance for the surgical mask (as provided in the document), which is the only relevant information from the text:

Acceptance Criteria and Reported Device Performance (Myflon Surgical Mask Level 3)

TestStandard/RegulationAcceptance CriteriaResults
Barrier Testing
Fluid resistanceASTM F1862Pass at 160mmHgPassed
Particle Filtration EfficiencyASTM F2299Pass $\geq$ 98%Passed
Bacterial Filtration EfficiencyASTM F2101Pass $\geq$ 98%Passed
Safety Testing
Flammability Class16 CFR 1610Class 1 ($\geq$ 3.5 seconds)Passed - Class I Non-Flammable
Physical Testing
Differential Pressure Delta-PEN14683Passed

§ 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.