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The Wellmien Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices.

Acceptance Criteria and Device Performance Study for Wellmien Surgical Mask (K101000)

This document describes the acceptance criteria and the study performed to demonstrate that the Wellmien Surgical Mask meets these criteria, as presented in the 510(k) submission K101000.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance of the predicate device (K060776) and relevant consensus standards. The study aimed to demonstrate substantial equivalence by showing comparable performance.

Note on Acceptance Criteria: For some tests like Fluid Resistance and Biocompatibility, the acceptance criterion is a qualitative assessment (e.g., "Fluid Resistance" or "Biocompatible") rather than a specific numerical threshold explicitly stated as separate acceptance criteria for the predicate device within this document. The study demonstrates that the Wellmien device also meets this qualitative assessment. For Delta-P, the Wellmien device's measured range falls within a generally acceptable range for surgical masks and is considered comparable to the predicate device, even if the average numerical value is different.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards would inherently specify sample sizes for each test.

The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing facilities or contract labs. The study is a retrospective evaluation based on laboratory bench testing of the finished device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation involved objective laboratory performance tests against established standards, not interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective clinical or imaging studies involving human readers. This information is not applicable as the study involved objective laboratory performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a physical device like a surgical mask.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study is typically associated with AI/software algorithms. This information is not applicable as the device is a physical surgical mask, and its performance is evaluated through material and filtration characteristics, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests was established by objective laboratory measurements against the specified consensus standards (e.g., ASTM F2101-07 for BFE, ASTM F2299-03 for PFE, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility, ASTM F1682-07 for fluid resistance). The performance of the predicate device also serves as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The Wellmien Surgical Mask is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical device.

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