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The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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.

Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are meet Level 3 requirements per ASTM F2100.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.

The Single-Use Surgical Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polypropylene fiber.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.

The provided document is a 510(k) premarket notification for a Single-Use Surgical Mask, not an AI/ML medical device. Therefore, many of the requested criteria regarding AI/ML model acceptance (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing and biocompatibility testing, along with a comparison of physical characteristics.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the sample sizes (number of masks tested) for each non-clinical test.
• Data Provenance: The tests were conducted by the manufacturer, Qiqihar Hengxin Medical Supplies, Ltd., in China. The data itself is "non-clinical testing" as opposed to "patient data".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. This pertains to AI/ML ground truth establishment. For surgical masks, "ground truth" is established by adherence to specified performance standards (e.g., ASTM F2100, 16 CFR 1610, ISO 10993). The performance is measured directly by laboratory tests, not by expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This pertains to AI/ML ground truth establishment for image or signal interpretation. Performance of a surgical mask is determined by standardized physical/biological tests, not by human adjudication of data interpretations.

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:

• No. This is not an AI/ML device, so no MRMC study was performed. The study is a non-clinical performance comparison to a predicate device.

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

• No. This is not an AI/ML device. The "standalone performance" here refers to the performance of the device itself (the mask) in physical and biological tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device is based on pre-defined, internationally recognized performance standards and methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993) which specify how physical and biological properties are measured and what constitutes acceptable performance for a Level 3 surgical mask.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device.

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The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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. Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is bule masterbatch. The Single-Use Surgical Mask with Ear Loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with Polyester. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The only difference is the dimension.

The provided text describes the acceptance criteria and study results for the "Single-Use Surgical Mask with Ear Loop" (K201691), demonstrating its substantial equivalence to a predicate device (K153496).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state the sample sizes for all tests beyond the Fluid Resistance (ASTM F1862) test, which mentions "31 out of 32 pass." The provenance of the data is not specifically detailed, but the tests were conducted to demonstrate compliance with various ASTM and ISO standards. The sponsor, Qiqihar Hengxin Medical Supplies, Ltd., is located in China, suggesting the testing likely occurred there or at a certified lab. The document does not specify if the studies were retrospective or prospective, though performance testing for regulatory submission is typically conducted prospectively.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. The evaluations are based on standardized laboratory performance tests, not expert interpretation of diagnostic images or clinical data requiring ground truth establishment by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable. The evaluations are based on objective measurements from standardized performance tests, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a surgical mask, and its evaluation relies on physical and biological barrier performance, not human reader interpretation of data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable to a physical medical device like a surgical mask. There is no algorithm or AI involved in its function that would require "standalone" performance testing. The evaluation focuses on the mask's inherent physical and material properties.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of this device is established by the prescribed methodologies and specifications of the referenced international standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define objective, measurable criteria for fluid resistance, filtration efficiency, differential pressure, flammability, cytotoxicity, irritation, and sensitization.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device (surgical mask) and not an AI/ML-based algorithm. Therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable, as there is no training set for this type of device.

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