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The Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Face Masks are single use, disposable devices, provided non-sterile.

Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.

There are two models for Face Mask with different colors and sizes.

For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.

The provided text describes the acceptance criteria and performance data for a medical device (Face Mask) in the context of an FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

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Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.

Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.

This is a medical device, not an AI/ML device. The provided text is a 510(k) Summary for a surgical mask, which is a physical product, not a software algorithm. Therefore, the questions regarding acceptance criteria and studies for an AI/ML device are not applicable.

The document discusses the substantial equivalence of the surgical mask to a predicate device based on material, intended use, mask style, design features, and performance test results against established consensus standards (e.g., ASTM, MIL-M, ISO).

Here's a breakdown of the relevant information provided for the surgical mask:

Acceptance Criteria and Device Performance (Surgical Mask)

The acceptance criteria for the surgical mask are implicitly defined by the performance characteristics of the predicate device (K061716) and relevant consensus standards. The study demonstrates that the device "meets" these criteria by showing its performance is similar to or better than the predicate device.

Irrelevant/Not Applicable Information for AI/ML Device Study:

The following questions are not applicable to this 510(k) submission for a surgical mask:

1. Sample sized used for the test set and the data provenance: Not applicable. Performance tests for physical masks follow specific standard protocols, not "test sets" in the AI sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical mask performance is based on standardized physical and chemical tests, not expert consensus on data interpretation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for a surgical mask's performance is based on physical and chemical testing according to recognized standards (e.g., ASTM, ISO).
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

FACE MASK, SURGICAL

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Face Mask, Surgical Mask, Non-Sterile." This document does not describe an AI/ML device or its performance criteria.

Therefore, I cannot provide the requested information, as the input document does not contain details about:

• Acceptance criteria for an AI/ML device
• A study demonstrating performance against such criteria
• Sample sizes for test or training sets
• Data provenance
• Ground truth establishment or type
• Expert qualifications or adjudication methods
• MRMC studies or standalone algorithm performance.

The document essentially states that the surgical face mask is substantially equivalent to legally marketed predicate devices and can proceed to market.

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