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The Surgical 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. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, 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 facemask. The elastic ear loops are not made with natural rubber latex.

The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text is a 510(k) summary for a Surgical Face Mask. It describes the device, its intended use, and the non-clinical tests conducted to demonstrate its substantial equivalence to a predicate device.

Here's the information extracted and organized as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Fluid Resistance: 32 samples were tested.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to non-clinical tests conducted to verify the device met design specifications and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the tests performed are non-clinical (laboratory tests) and do not involve human diagnostic assessment or ground truth established by experts in the context of clinical scenarios.

4. Adjudication Method for the Test Set

This section is not applicable as the tests performed are non-clinical laboratory tests and do not involve human adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of non-clinical laboratory testing. The device's performance was evaluated against established standards for medical face masks (ASTM F2100 Level 3). The results in the table above represent the algorithm-only performance against these standards, as there is no human-in-the-loop for these types of tests.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is established by industry standards and regulatory requirements, specifically ASTM F2100, ISO 10993-5, ISO 10993-10, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, and 16 CFR 1610. These standards define the quantitative and qualitative acceptance criteria for the performance and safety characteristics of surgical face masks.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (Surgical Face Mask), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would relate to production batches, but not a training set for an algorithm.

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

This information is not applicable for the same reason as point 8; there is no training set mentioned for this medical device.

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The surgical 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. This is a single use, disposable device(s), provided non-sterile.

The surqical face masks are pleated 3 plys sinqle use, disposable masks. Inner layers and outer layers are made of spun-bond polypropylene. Middle layer is made of melt blown polypropylene filter. Earloops are Knitted Elastic loops (not made with natural rubber latex). Tieon is made of spun-bond polypropylene. The nose piece is a malleable aluminum wire.

The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI/ML powered device. As such, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of regulatory submission.

However, I can extract the acceptance criteria and reported device performance based on the non-clinical tests conducted to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the surgical face masks are based on recognized standards and demonstrate the product's performance for bacterial filtration, particulate filtration, fluid resistance, flammability, and biocompatibility.

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

• Sample Size for Test Set: Not specified in the document. For these types of standard tests, statistical sampling plans are typically used, but the specific numbers are not provided.
• Data Provenance: The tests were conducted to specific ASTM, MIL, CFR, and ISO standards, indicating laboratory testing conditions. The country of origin for the testing itself is not explicitly stated, but the manufacturer is BH Medical Products Co., Ltd. in Changzhou, Jiangsu, China. The document does not specify if the studies were retrospective or prospective; due to the nature of product performance testing, they would be considered prospective laboratory studies.

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

• This is not applicable for surgical face mask performance testing. "Ground truth" in this context is defined by objective physical and biological measurements against established standards, not expert consensus interpretation.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against objective standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (surgical face mask).

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

• No, this is not a software/AI-based device. Performance tests are inherently "standalone" in the sense that they measure the device's physical and biological properties.

7. The type of ground truth used:

• The "ground truth" for the performance claims of the surgical face mask is based on objective measurements against established national and international standards (ASTM, MIL, CFR, ISO). These standards define specific methodologies and acceptance criteria for demonstrating performance (e.g., filtration efficiency, fluid resistance, flammability, cytotoxicity).

8. The sample size for the training set:

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