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The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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/sterile.

The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white. The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.

The provided document is a 510(k) premarket notification for a "Protective Face Mask for Medical Use." It assesses the substantial equivalence of the proposed device to predicate devices. The study conducted is a non-clinical performance test, not a study involving human readers or AI.

Here's the breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size:
  • Fluid Resistance Performance: 32 samples (indicated by "32 out of 32 pass")
  • For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), the exact sample size is not explicitly stated, but the results are reported as meeting the criteria.
• Data Provenance: The tests were conducted to support the 510(k) submission from Hunan Heng Chang Pharmaceutical Co., Ltd. in China. The study is a non-clinical performance test of the device itself, not a study based on patient data, so "retrospective or prospective" and "country of origin of the data" in the typical clinical sense are not applicable. It's a laboratory-based device performance evaluation.

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 is a submission for a medical face mask, evaluated against established performance standards (ASTM, EN, ISO, CFR) through physical and biological testing, not through expert interpretation of medical images or diagnoses. Ground truth is defined by the objective measurement criteria of these standards.

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

Not applicable. This document describes laboratory performance testing, not a study involving human interpretation or adjudication. The results are based on objective measurements according to defined test methods.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical study is included in this submission."

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

This is not applicable, as the device is a physical medical face mask, not an AI algorithm.

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

The "ground truth" for the non-clinical tests is represented by the objective acceptance criteria defined in internationally recognized standards such as ASTM F1862M-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR 1610, ISO 10993-5: 2009, and ISO 10993-10: 2010. These standards specify how the device should perform under controlled laboratory conditions.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As above, this is a physical device, not an AI model.

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The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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, provided non-sterile.

The Protective Face Mask for Medical Use is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color.

This document is a 510(k) Premarket Notification submission for a medical device, specifically a "Protective Face Mask for Medical Use." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a "Performance testing" table (Table 2) that directly addresses this point.

Additionally, a "Biocompatibility testing" table (Table 3) is provided:

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

• Sample Size for Test Set:
  • For Fluid Resistance Performance, the sample size is explicitly stated as 32 (implied by "32 out of 32 pass").
  • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and all Biocompatibility tests, the exact sample size is not explicitly stated in this document. It is only reported that the tests were done and passed.
• Data Provenance: The document does not specify the country of origin of the data for the tests. It states the submitter's address is in Jinan, Shandong, China, implying the testing could have been conducted in China, but this is not explicitly confirmed for the test data itself. The testing type is non-clinical testing, which is typically conducted in a laboratory setting, not a retrospective or prospective clinical study on human subjects for this type of device.

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

This information is not applicable to this submission. The "ground truth" for a surgical mask primarily relies on objective, standardized physical and biological performance tests (e.g., filtration efficiency, fluid resistance) conducted in laboratories, not on human expert consensus or interpretation of images/data, as would be the case for AI/image analysis devices. The standards themselves (e.g., ASTM, ISO, EN) define the accepted methods and criteria.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Laboratory tests for physical performance of a mask do not involve adjudication by multiple experts in the same way clinical data or imaging studies do.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study would be relevant for software or AI devices where human performance with and without AI assistance is being evaluated. This is a physical device (surgical mask) whose performance is evaluated through standardized laboratory tests.

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

Not applicable/No. This is not an algorithm or AI device. The testing conducted was standalone performance of the physical mask itself in laboratory conditions, according to specified standards.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective, standardized laboratory measurements and adherence to established industrial and medical device standards (e.g., ASTM F1862M-17 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101-19 for bacterial filtration, EN 14683:2019 Annex C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 series for biocompatibility). These standards define the acceptable performance thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a software/AI device that requires a "training set" for machine learning.

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

This information is not applicable for the same reason as point 8.

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