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The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

FILTECH M201 Disposable Surgical Mask is a single use, that-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in blue of outside and white of inside. FILTECH M201 Disposable Surgical Mask is provided non-sterile and for single use.

Here's an analysis of the acceptance criteria and study information for the Disposable Surgical Mask (FILTECH M201), extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance (ASTM F1862): 32 samples were used.
• Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta-P), and Flammability (16CFR 1610): The specific sample sizes for these tests are not explicitly stated within the provided document. However, since these are non-clinical performance tests on the device itself, the data provenance is from laboratory testing of the manufactured product.
• Data Provenance: The tests were performed on the proposed device (FILTECH M201) manufactured by HANGZHOU FILTECH INTELLIGENT CO., LTD in China. The data would be considered retrospective as it was collected before the submission date for the 510(k) application.

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 as the provided document describes non-clinical performance testing of a physical product (a surgical mask), not a diagnostic or AI-driven medical device that requires expert ground truth for interpretation of results. The "ground truth" for these tests is defined by the objective measurement standards outlined in the ASTM and CFR standards.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretation (e.g., radiologists reviewing images), not for objective physical performance testing of a device.

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. The device is a Disposable Surgical Mask, which is a physical protective barrier. It is not an AI-driven device or an imaging product that involves human readers or AI assistance. No MRMC study was performed.

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

This information is not applicable. The device is a Disposable Surgical Mask, not an algorithm or AI system.

7. The type of ground truth used:

For the performance tests, the "ground truth" is established by adherence to recognized international and national standards:

• Fluid Resistance: ASTM F1862 standard.
• Particulate Filtration Efficiency: ASTM F2299 standard.
• Bacterial Filtration Efficiency: ASTM F2101 standard.
• Differential Pressure: MIL-M-36954C standard.
• Flammability: 16CFR 1610 standard.
• Biocompatibility: The results are derived from laboratory testing against established biological evaluation standards (e.g., cytotoxicity, irritation, sensitization).

8. The sample size for the training set:

This information is not applicable. The Disposable Surgical Mask is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable for the reasons stated above.

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