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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.

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. *

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:

Study Proving Device Meets Acceptance Criteria:

The document describes pre-market testing and comparison to a predicate device, not a "study" in the typical sense of a clinical trial or AI model validation. The "proof" relies on adherence to recognized standards and certifications.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a "sample size" in the context of subject recruitment. The tests are conducted on manufactured products. The number of masks/respirators tested for each performance metric (e.g., fluid resistance, BFE, PFE, flammability) is not specified in this summary, but would adhere to the sample size requirements defined by the respective ASTM, NIOSH, or CFR standards.
   • Data Provenance: The tests are standard performance evaluations for the device, likely conducted by the manufacturer (3M Health Care) or certified laboratories. The information does not specify the country of origin of testing, nor does it distinguish between retrospective or prospective data generation, as it pertains to product performance testing rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. "Ground truth" in this context refers to the defined performance standards (e.g., ASTM F1862 for fluid resistance) and the physical properties of the device, measured by laboratory equipment, rather than expert interpretation of medical images or clinical outcomes.

3. Adjudication method:

   • Not applicable, as there are no human interpretations or disagreements that require adjudication. Performance metrics are objectively measured against established standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a physical product (respirator/mask), not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical product.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is based on recognized industry standards and laboratory test methods (e.g., NIOSH certification for PFE and differential pressure, ASTM F1862 for fluid resistance, ASTM F2101 for BFE, 16 CFR 1610 for flammability, and ISO 10993-1 for biocompatibility). These standards define the acceptable range or threshold for a product to be considered effective and safe for its intended use.

7. The sample size for the training set:

   • Not applicable. This is not an AI/Machine Learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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