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This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8) The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask. The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line. The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device. The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).

This document is a 510(k) summary for a Medical Surgical Mask (Models: MP002-5, MP002-6). The acceptance criteria and performance data provided relate to the physical and performance characteristics of the mask itself, rather than a diagnostic device with an AI algorithm. Therefore, many of the requested points regarding AI model evaluation (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance) are not applicable to this submission.

Here is the information that can be extracted from the provided document, tailored to the type of device (a surgical mask):

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

The document compares the subject device to a predicate device and also lists specific performance test results against established standards.

Note 2 in the original document states: "Although the "Particulate Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device."

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

The document does not specify the exact sample sizes (number of masks tested) for each physical performance test. However, it indicates that the tests conducted ("lab bench testing") are standard for demonstrating performance of such devices. The data provenance is implied to be from a testing facility in China, as the manufacturer is based there. The studies are by nature prospective, as they are conducted specifically for this submission.

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

This is not applicable as the "ground truth" for this device is based on objective, quantifiable physical and biological tests conducted in a laboratory setting according to international standards (e.g., ASTM, ISO). It does not involve human expert interpretation or consensus as would be the case for an AI diagnostic device.

4. Adjudication method for the test set

Not applicable. Test results are based on objective measurements from laboratory instruments and procedures, not human adjudication.

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

Not applicable. This is a physical medical device (surgical mask), not a diagnostic device involving human readers or AI assistance.

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

Not applicable. There is no algorithm or AI component to this device.

7. The type of ground truth used

The ground truth for this device is established through:

• Standardized Bench Testing: Performance metrics (e.g., filtration efficiency, pressure differential, fluid resistance, flammability) are measured using established ASTM and European (EN) standards.
• Biocompatibility Testing: Safety (cytotoxicity, irritation, sensitization) is assessed using ISO 10993 series standards.
  These are objective, quantitative measurements against defined criteria.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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