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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. This is a single use device provided non-sterile.

The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.

The provided document describes the acceptance criteria and the study that proves the performance of a Single-Use Surgical Mask (K211773). This is a non-clinical study, as stated in section 8. Clinical Testing.

Here's a breakdown of the requested information:

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

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

The document does not explicitly state the sample sizes used for each individual test. It mentions "non-clinical testing" and the results are presented as "Pass" for each criterion. The data provenance is also not specified in terms of country of origin or whether it's retrospective or prospective, beyond being non-clinical (laboratory-based) tests.

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

This information is not applicable. The device is a surgical mask, and its performance criteria are objectively measured via standardized laboratory tests (e.g., ASTM, ISO, EN standards) rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable. The tests are laboratory-based and produce quantitative results compared against predefined thresholds, not subjective assessments requiring adjudication.

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

There was no MRMC comparative effectiveness study. This document describes the performance of a physical device (surgical mask) through non-clinical testing, not an AI or diagnostic imaging device that would involve human readers.

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

This information is not applicable. The subject is a physical surgical mask, not an algorithm.

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

The "ground truth" for the performance of the surgical mask is established by the specified industry and regulatory standards and test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define objective criteria and measurement procedures.

8. The sample size for the training set

This information is not applicable. This is not a study involving a training set for an algorithm or a similar machine learning context. The tests are for a physical product.

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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The Single-use Surgical 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.

Single-use Surgical Mask Model FE2311B

This document is a 510(k) clearance letter for a Single-Use Surgical Mask and does not contain information about the acceptance criteria or a study proving the device meets criteria in the way typically associated with AI/ML devices or clinical trials.

The document is a regulatory clearance for a physical medical device (a surgical mask), which goes through a different evaluation process than software or AI-driven diagnostics. The "acceptance criteria" for a surgical mask are typically based on material properties and performance standards (e.g., fluid resistance, particulate filtration efficiency, breathability), which are demonstrated through laboratory testing, not clinical studies with "ground truth" established by experts or MRMC studies.

Therefore, I cannot provide the requested information from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types and training set details) are relevant for evaluating AI/ML medical devices, but not for a conventional surgical mask as described in this FDA clearance letter.

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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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The Single-use Surgical Masks (Model:FE2311) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has 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 spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The model of proposed device, ear loops, is 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 nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The document is a 510(k) summary for the BYD Single-use Surgical Mask, মডেল FE2311. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are established by various standards and the FDA guidance for surgical masks. The reported performance of the subject device (BYD Single-use Surgical Mask) is compared to criteria from these standards and the predicate device.

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

• Fluid Resistance: 32 samples were tested.
• Other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample sizes for each of these tests, but it indicates adherence to the respective ASTM and ISO standards, which would define appropriate sample sizes.
• Data Provenance: The tests were non-clinical, conducted in accordance with international standards (ASTM, ISO, CFR) and FDA guidance for surgical masks. No specific country of origin for the test data is mentioned, but the manufacturer is based in China. The data would be considered prospective, as it was generated 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 a non-clinical performance study of a device (surgical mask) based on standardized laboratory tests, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" is established by the test methodologies and results themselves, as defined by the cited standards (e.g., ASTM F2100, ISO 10993). Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not applicable here. The experts involved would be the laboratory technicians and scientists performing the tests and ensuring compliance with the standards,
and this is not explicitly detailed in the document.

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

Not applicable. This is a non-clinical laboratory performance study, not a study involving human readers or expert adjudication of subjective findings. The test results are objective measurements against defined criteria.

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 a 510(k) submission for a physical medical device (surgical mask), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.

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

No. This is a non-AI medical device. The "standalone performance" refers to the device's intrinsic mechanical and filtration capabilities as measured by the laboratory tests.

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

The "ground truth" is based on standardized test methods and established performance criteria laid out in recognized industry standards (ASTM, ISO, CFR). For example:

• Fluid resistance is "ground-truthed" by passing or failing the 160 mmHg pressure spray.
• Filtration efficiencies are "ground-truthed" by the measured percentage retention of particles or bacteria.
• Biocompatibility is "ground-truthed" by standard cytotoxic, irritation, and sensitization assays.

8. The sample size for the training set:

Not applicable. This is a non-AI medical 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 type of device.

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