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Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Disposable Medical Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

The provided document describes the acceptance criteria and the study that proves the performance of a Disposable Medical Surgical Face Mask.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific numerical sample size used for each test. Instead, it generically states "All samples met the predetermined acceptance criteria." for the results.

Regarding data provenance:

• The tests were conducted as non-clinical data as per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions.
• The manufacturer is Guangdong Haiou Medical Apparatus Co., Ltd. located in China.

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

This information is not applicable and not provided in the document. The testing described is for a medical face mask, and involves objective performance criteria (e.g., filtration efficiency, fluid resistance) measured against established industry standards (ASTM, ISO, CFR). It does not involve human expert interpretation of images or other data to establish a "ground truth" in the way an AI diagnostic device would.

4. Adjudication method for the test set

This information is not applicable and not provided in the document for the reasons stated in point 3.

5. 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

This information is not applicable and not provided in the document. This is not a study involving human readers or AI assistance. It's a performance test for a physical medical device.

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

This information is not applicable and not provided in the document. The device is a physical face mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the Disposable Medical Surgical Face Mask is established by objective measurements against recognized industry standards and regulatory requirements. These include:

• ASTM F1862 (Fluid Resistance)
• ASTM F2100-19 (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency)
• 21 CFR 1610 (Flammability)
• ISO 10993-5 (Cytotoxicity)
• ISO 10993-10 (Irritation and Sensitization)

8. The sample size for the training set

This information is not applicable and not provided in the document. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

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