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3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804/1804S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Device Description

The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S are provided as a flat-folded Surgical N95 Respirator composed of multi layers of materials consisting of polypropylene spunbond (inner web), polypropylene (filter web), polypropylene spunbond (outer web). The product contains an aluminum nose clip within the layers of the top edge of the product to conform to the contours of the face. In addition, the product contains two steel staples used to secure the two polyisoprene elastic headbands (not made with natural rubber latex) to the product and the headbands are to secure the product in place on the wearer. The products are provided only in white and provided in two sizes one being small.

The 3MM VFlex™ Health Care Particulate Respirator and Surgical Mask, 1804/1804S is an particulate respirator. Particulate respirators help reduce the wearer exposure to certain airborne particles. including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oilt. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials and meets >99% bacterial filtration efficiency (BFE) ±. It is cleared to be worn in surgery. It can fit a wide range of face sizes. CDC guidelines state N95 respirators may be used for M. tuberculosis. *

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870).

The provided text describes the device, its intended use, and a comparison to a predicate device based on various features and performance specifications. However, this document does not describe a study involving an AI/Machine Learning device, human readers, or image analysis for medical diagnosis. It details the acceptance criteria and performance data for a physical product, specifically a surgical mask/respirator.

Therefore, many of the questions regarding AI/ML study design (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable to this type of device submission.

Here's a breakdown of the information that is relevant to the provided text, structured as requested where possible:

Acceptance Criteria and Device Performance for a Surgical Mask/Respirator:

Acceptance Criteria (Performance Specification)	Target/Standard	Reported Device Performance (3M™ VFlex™ 1804/1804S)	Predicate Device Performance (3M™ 1870)
Particulate Filtration Efficiency (PFE)	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification
Differential Pressure (Delta P)	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification	NIOSH Certification N95 Classification
Fluid Resistance (ASTM F1862)	Pass 80 mmHg	Pass 80 mmHg	Pass 160 mmHg
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥ 99 (%)	≥ 99 (%)	≥ 99 (%)
Flammability (CFR 16 1610)	Class I	Class I	Class I
NIOSH Certification	N95 Classification	N95 Classification (TC-84A-7789 for 1804, TC-84A-7790 for 1804S)	N95 Classification (84A-3884)
Biocompatibility (ISO 10993-1)	Acceptable for surface contacting device with prolonged (

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