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Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document sometimes lists the predicate's performance in the "Acceptance Criteria" column implicitly by comparing the new device's performance to it. For particulate filtration, it seems the predicate's "2.0 microns" is the filtration size it achieves, and the new device achieves a much higher percentage at a smaller particle size (0.1 micron), indicating superior performance.

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

The document does not specify the sample size used for the test set for any of the performance criteria (Fluid Resistance, Particulate Filtration, BFE, Delta-P, Flammability).

The data provenance is not explicitly stated. However, given that Hong Ya Non-Woven Products Co., Ltd. is located in P.R. China and the submission is to the FDA, it's highly probable the testing was conducted retrospectively on samples of the manufactured device. The location where the tests were performed is not mentioned.

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

This information is Not Applicable in this context. The study is a series of non-clinical, laboratory-based performance tests for a surgical mask. Ground truth is established by the standardized methods of the tests themselves, not by expert consensus on clinical data. For example, BFE is measured by a specific laboratory procedure, not by a panel of experts reviewing cases.

4. Adjudication Method for the Test Set

This information is Not Applicable. As with the ground truth, the tests are objective laboratory measurements, not subjective evaluations requiring adjudication among multiple observers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. The listed tests are non-clinical performance evaluations of a physical product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation was done. All the tests (Fluid Resistance, Particulate Filtration Efficiency, BFE, Delta-P, Flammability) are standalone assessments of the device's physical properties and performance characteristics, without human intervention in the loop for interpreting results.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by standardized laboratory test methods. The specific standards mentioned include:

• Fluid Resistance: ASTM F1862-05 (Synthetic Blood Penetration Resistance Test)
• Bacterial Filtration Efficiency (BFE): ASTM F2101-01
• Particulate Filtration Efficiency: ASTM F1215 (Latex Particle Challenge)
• Differential Pressure (Delta-P): MIL M 36954 C
• Flammability: 16CFR 1610
• Biocompatibility: ISO 10993

8. The Sample Size for the Training Set

This information is Not Applicable. Surgical masks are not typically "trained" in the sense of machine learning algorithms. The device's performance is inherent to its design and materials.

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

This information is Not Applicable for the reasons stated in point 8.

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Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue):

Summary: This document describes a 510(k) submission for a surgical face mask. The core of the submission is demonstrating substantial equivalence to a predicate device (Tucker & Associates Surgical Face Mask K022256) through a series of non-clinical, bench-top performance tests. No clinical studies or human-in-the-loop studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" but rather presents a comparison table showing the performance of the applicant's device against "K022256" (the predicate device). The implicit acceptance criterion is that the new device's performance should be comparable to or better than the predicate device.

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

• Sample Size: The document does not specify the exact sample sizes used for each performance test (e.g., how many masks were tested for BFE). It just states "Performance testing met all relevant requirements."
• Data Provenance: The data is from non-clinical bench testing. The tests were performed to support substantial equivalence to a predicate device. The country of origin for the testing facilities is not explicitly stated, but the manufacturer is based in China. The data would be considered prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

• Not Applicable. For this type of device (surgical mask) and submission (510(k) based on bench testing), "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The "ground truth" for these tests is defined by the objective results of the standardized test methods themselves (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human interpretations or readings involved, no adjudication method (like 2+1 or 3+1 consensus) was used. The tests produce objective measurements.

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

• No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where different readers interpret cases with and without AI assistance to measure the impact of AI on their performance. This submission for a surgical mask focuses on material performance, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. There is no AI algorithm or software component in this device. The device is a physical surgical face mask.

7. The Type of Ground Truth Used

• The "ground truth" for the performance tests is derived from standardized physical and material property measurements as defined by the referenced ASTM (American Society for Testing and Materials) and other relevant standards (e.g., ASTM F1862-00a for fluid resistance, ASTM F2101-01 for BFE, ASTM F1215-89 for particulate filtration, MIL M 36954C for Delta P, 16 CFR 1610 for flammability, and ISO 10933 for biocompatibility). These standards define the test methods and the expected outcome or measurement for compliance.

8. The Sample Size for the Training Set

• Not Applicable. There is no AI model or algorithm, so there is no training set in the machine learning sense. The device is a physical product.

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

• Not Applicable. As there is no training set, this question is irrelevant.

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