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The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.

Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (M643BE). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, 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:

• Sample Size: For performance testing (BFE, Differential Pressure, Particulate Filtration, Synthetic Blood Resistance, Flammability), the sample size used was 32 units per lot for 3 non-consecutive lots.
• Data Provenance: The document does not explicitly state the country of origin where the tests were performed or if the data was retrospective or prospective. Given that the applicant is in Taiwan and the submission correspondent is in China, the testing likely occurred in one of these regions. The testing described is prospective (i.e., new tests conducted 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 submission does not involve a clinical study or human interpretation of data for the ground truth. The "ground truth" for the performance testing is established by the specified ASTM, EN, and CFR standards' methodologies and acceptance criteria. The qualifications of the personnel performing these standardized laboratory tests are not detailed but are assumed to meet the requirements of the testing laboratories.

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

Not applicable. This is not a study involving human readers or subjective interpretation that would require adjudication. The tests are objective, laboratory-based performance measurements against defined standards.

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 document pertains to a physical medical device (face mask), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed.

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

Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the physical properties of the mask tested in a laboratory setting.

7. The type of ground truth used:

The ground truth for this device's performance is based on established industry standards and regulatory requirements (ASTM, EN, CFR, ISO standards). These standards define the test methods and the acceptable performance thresholds for medical face masks.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model; 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 a physical medical device.

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The Disposable Medical Face Mask is intended to be worn to protect 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.

Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the acceptance criteria and the results of a study for a Disposable Medical Face Mask (K223055) to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used.
• Data Provenance: The document does not explicitly state the country of origin of the data for these tests. However, the applicant is Xiantao Zhuobo Industrial Co., LTD, located in Hubei Province, China. The tests are non-clinical (laboratory tests) rather than retrospective or prospective clinical data.

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

• This device is a Disposable Medical Face Mask, and the evaluation is based on non-clinical performance testing against established industry standards (ASTM, EN, ISO, CFR). Therefore, the concept of "experts used to establish ground truth" as it would apply to a diagnostic imaging device, for example, is not applicable here. The "ground truth" is defined by the objective pass/fail criteria of the scientific/engineering standards themselves.

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

• Not applicable. The tests are objective measurements against predefined thresholds, not subjective assessments requiring adjudication by multiple readers.

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:

• Not applicable. This is a physical medical device (face mask) and not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.

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

• Not applicable. This is not an algorithm or AI device.

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

• The ground truth for this device's performance is based on established quantitative and qualitative criteria defined by international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). For biocompatibility, the ground truth is the classification as "non-cytotoxic," "non-irritating," and "non-sensitizing" as per ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical medical devices being evaluated through non-clinical performance and biocompatibility testing. This is not an AI/machine learning device.

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

• Not applicable, as there is no training set for this type of device and study.

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The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond 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 face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.

1. 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):

For all performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the sample size used was 32 units per lot, across 3 non-consecutive lots.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the document is a 510(k) submission to the US FDA from a Chinese applicant (Wellmed Dental Medical Supply Co., Ltd. in Shenzhen, China), suggesting the tests were likely conducted by or for the manufacturer in China or by a certified lab for regulatory submission purposes. These are non-clinical (laboratory) tests performed specifically for regulatory approval.

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, laboratory-based performance and biocompatibility study for a medical device (face mask). There is no "ground truth" in the clinical sense established by human experts like radiologists. The "ground truth" is determined by established scientific standards and test methods (e.g., ASTM, EN, ISO standards), with results measured by laboratory equipment and qualified personnel following those protocols. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically understood in AI/clinical studies does not apply here.

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

Not applicable. This is a non-clinical, laboratory-based performance and biocompatibility study. Adjudication methods are typically relevant for human-interpreted data, such as medical images or clinical diagnoses.

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:

Not applicable. This is a non-clinical study for a medical face mask. It does not involve human readers, AI, or clinical effectiveness studies in this context.

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

Not applicable. This device is a physical medical product (a face mask), not a software algorithm.

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

The "ground truth" in this context is defined by the objective, reproducible measurements against established performance standards and specifications outlined in the referenced international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria for each test (e.g., "$\geq$ 98%," "< 6.0mmH2O/cm²") numerically define the acceptable performance.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a 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.

Ask a specific question about this device

The Disposable Medical 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 Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.

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

This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance: 32 samples per lot, across 3 lots.
• Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Cytotoxicity, Irritation, Sensitization: The document does not specify the exact sample size for these tests, only that the results passed. The provenance of the data is not explicitly stated beyond originating from "Non-Clinical Test Conclusion," which implies laboratory testing. The manufacturer is Xiantao Topmed Nonwoven Protective Products Co., Ltd. in China, so the testing was likely conducted in China. The data is retrospective in the sense that it was collected as part of the submission process to demonstrate equivalence.

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

This submission does not involve expert-established ground truth in the context of diagnostic interpretation. It relies on standardized laboratory testing and established regulatory guidance (ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10) for evaluating the performance of the face mask. The "ground truth" for each performance metric is defined by the acceptance criteria of these standards. The experts would be the accredited laboratory personnel performing these standardized tests,
but their specific number and qualifications are not detailed in this document.

4. Adjudication method for the test set:

Not applicable. The tests are objective, standardized laboratory tests with defined passing criteria. There is no subjective interpretation or adjudication needed for the results.

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:

Not applicable. This device is a medical face mask, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a medical face mask, not an AI-powered algorithm. It does not have a "standalone" or "human-in-the-loop" performance in the context of an algorithm.

7. The type of ground truth used:

The ground truth is based on pre-defined, internationally recognized technical standards and test methodologies for medical face mask performance, such as ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.

8. The sample size for the training set:

Not applicable. This is a physical medical device (face mask), not a machine learning model that requires a 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.

Ask a specific question about this device

The Disposable Medical Face Mask is 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 Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.

The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance metrics, multi-reader multi-case studies, effect size of human readers improving with AI, standalone algorithm performance, and ground truth establishment/training sets, are not applicable.

However, I can extract the acceptance criteria and reported device performance for this medical face mask from the document:

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

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

• For Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: 3 non-consecutive lots were tested, with a sample size of 32 per lot.
• For Fluid Resistance: The predicate device had 32 out of 32 per lot passing. The subject device simply states "pass at 120 mmHg," implying similar testing was conducted.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were non-clinical, conducted by Hubei Mediunion Medical Products Co., Ltd. for their proposed device.

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

• Not applicable. These are objective physical and biological performance tests for a medical face mask, not expert-adjudicated diagnoses or interpretations.

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

• Not applicable. These are objective physical and biological performance tests.

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:

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

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

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

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

• Objective Test Standards: The "ground truth" or acceptance criteria are based on established international and national standards for medical face mask performance, such as ASTM F1862, ASTM F2101, ASTM F2100, EN 14683, ISO 10993-5, ISO 10993-10, and 16 CFR Part 1610. The device's performance is measured directly against these standard specifications.

8. The sample size for the training set:

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

Ask a specific question about this device

The Disposable Medical Face Mask is 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.

Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-powered medical device. Therefore, most of the requested information about an AI-powered device, such as MRMC studies, training set details, or expert ground truth establishment, is not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical properties of the face mask as tested.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure:

  • Sample Size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used for each test. (e.g., 32 samples for fluid resistance from Lot1, 32 from Lot2, 32 from Lot3).
  • Data Provenance: Not explicitly stated as retrospective or prospective, but these are standard laboratory tests on manufactured lots. The manufacturer is Xiantao Zhibo Nonwoven Products Co., Ltd. in Hubei, China, so the testing would likely have occurred in China or at a contract lab.

• Biocompatibility (Cytotoxicity, Irritation, Sensitization):

  • Sample Size: Not explicitly stated as a number of devices/samples, but the tests were performed on "mask material" based on ISO10993 standards.
  • Data Provenance: Not specified, but likely conducted by the manufacturer or a contracted lab to meet ISO 10993 requirements.

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 as the document describes physical performance testing of a medical face mask, not an AI device that requires expert-established ground truth for image/data interpretation. The ground truth for these tests is based on the results of standardized laboratory measurements and physical/chemical properties.

4. Adjudication method for the test set:

This is not applicable. The tests performed are objective laboratory measurements, not interpretations 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:

This is not applicable. This document is about a physical medical device (face mask), not an AI-powered diagnostic device.

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

This is not applicable. This document is about a physical medical device (face mask), not an AI-powered algorithm.

7. The type of ground truth used:

The ground truth for these tests is based on objective laboratory measurements and established physical/chemical standards for material performance (e.g., precise measurements of filtration efficiency, pressure differential, and biological assays for cytotoxicity/irritation/sensitization). There is no "expert consensus" in the sense of radiological or pathological interpretations.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is a physical device, not an AI model.

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

This is not applicable. There is no "training set" or corresponding ground truth establishment for this type of device.

Ask a specific question about this device

The Disposable Medical Face Mask is 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 Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. 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 nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and the study that proves the device (Disposable Medical Face Mask, K202676) meets these criteria. All information is extracted directly from 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

The sample size is specified for certain tests:

• Resistance penetration synthetic blood (ASTM F1862): 32 samples per lot (tested across 3 lots).
• For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the specific sample size per test is not explicitly stated, but results are provided for 3 lots.
• For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated beyond what is implied by the methodology (e.g., L-929 cells, rabbits, guinea pigs).

The data provenance is not explicitly stated in terms of country of origin for the testing, nor whether it was retrospective or prospective. However, the manufacturer is from China (Zhejiang Senhong Medical&Instrument Co., Ltd.) and the submission was made to the US FDA. The studies appear to be laboratory-based non-clinical performance 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 and not provided. The ground truth for these tests is established by standardized test methodologies and their respective measurement criteria, not by expert consensus or interpretations. For example, for "Resistance penetration synthetic blood," the ground truth is simply whether the specific number of samples passed the physical penetration test at a certain pressure.

4. Adjudication method for the test set

Not applicable. The tests are standardized physical and biological performance assessments, not subjective evaluations 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

Not applicable. This device is a disposable medical face mask, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

Not applicable. This is not an algorithm or AI device. The tests are for the physical and biological performance of the mask itself.

7. The type of ground truth used

The ground truth for the device's performance is based on established industry standards and regulatory requirements for medical face masks. This includes:

• Physical properties (e.g., filtration efficiency, differential pressure, flammability) measured against quantitative thresholds.
• Biocompatibility properties (e.g., cytotoxicity, irritation, sensitization) measured against predefined biological responses.
  The "ground truth" is determined by the results of these standardized laboratory tests meeting the pre-defined acceptance criteria.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

Ask a specific question about this device

The Disposable medical face mask 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(s), provided non sterile.

The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. 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 nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (K202745), not an AI-powered medical device. Therefore, many of the requested fields related to AI/MRMC studies, number of experts, and ground truth establishment are not applicable.

However, I can extract the information relevant to the performance testing of the medical face mask as described in the document.

Here's a breakdown of the acceptance criteria and study results for the Disposable Medical Face Mask:

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing:

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

• Sample Size for Performance Testing: Three nonconsecutive lots were tested, with each lot having 32 samples, for a total of 96 samples.
• Data Provenance: The document does not explicitly state the country of origin of the data beyond the manufacturer being in China. The testing was described as conforming to recognized standards like ASTM F2100-19 and FDA guidance. The studies are retrospective in the sense that they are conducted on manufactured samples to demonstrate compliance.

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

• Not Applicable. This is a physical product (face mask) with performance measured against established physical and chemical standards (e.g., filtration efficiency, pressure differential, blood penetration). It does not involve human expert interpretation for "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, the tests are objective measurements against defined standards, not subjective interpretations 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

• Not Applicable. This device is a disposable medical face mask, not an AI-powered diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This is a physical product, not an algorithm.

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

• The "ground truth" for this device's performance is based on pre-defined, objective, and standardized laboratory test methods (e.g., those referenced in ASTM F2100-19) and their corresponding quantitative or qualitative pass/fail criteria. These standards are established through expert consensus in the field of material science and medical device testing, but not for case-by-case "ground truth" establishment as in diagnostic imaging.

8. The sample size for the training set

• Not Applicable. This refers to a manufactured physical product; there is no "training set" in the context of an algorithmic device.

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

• Not Applicable. As above, there is no training set for this type of device.

Ask a specific question about this device

The Disposable Medical 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.

Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Disposable Medical Face Mask:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each performance test. It mentions for Fluid Resistance (ASTM F1862) that "32 out of 32 Pass at 120mmHg". This implies a sample size of 32 for that specific test. For other performance tests (BFE, Delta-P, PFE, Flammability) and biocompatibility tests, the sample sizes are not explicitly provided within this summary.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). The submitting company is Suzhou Bolisi Medical Technology Co., Ltd in China, which suggests the testing was likely conducted in China or a contracted lab. It's safe to assume these are prospective tests performed specifically for this submission.

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

This information is not applicable to this type of device. The ground truth for performance standards of medical masks is established by standardized test methods (e.g., ASTM, EN, ISO) and the results are objectively measured by laboratories, not through expert consensus on cases.

For biocompatibility testing, the results are also determined by standardized laboratory assays, not by expert review of "cases."

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective, quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.

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 imaging devices where human interpretation is involved. For a product like a disposable medical face mask, the assessment relies on objective performance testing and biocompatibility.

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

No, this is not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established performance standards and test methodologies for medical face masks and biocompatibility. Specifically:

• Performance Standards: ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610. These standards define the acceptable physical and filtration properties.
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization). These standards define the acceptable biological response to the device materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for this type of medical device. The device's performance is not based on a machine learning model that needs training data.

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

This is not applicable for the same reason as above.

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Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.

The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm.

The models MK-34, DY 95 and DY 97, ear loops, are 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 of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm.

The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.

The device is sold non-sterile and are intended to be single use, disposable device.

This document is a 510(k) premarket notification for a Disposable Medical Face Mask, not a study describing the performance of a medical device against specific acceptance criteria in the context of an AI/human reader study. Therefore, most of the questions regarding acceptance criteria and study design for AI/human performance are not applicable.

However, I can extract the acceptance criteria and reported performance for the Disposable Medical Face Mask based on non-clinical testing of the physical characteristics of the mask.

Here's the information based on the provided text, focusing on the mask's non-clinical performance and not on AI/human reader studies.

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

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

The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many masks were tested for BFE, PFE, etc.). It only provides the results for the different models of the mask. The data provenance is testing conducted for Guangzhou Mei Yi Kang Medical Technology CO., LTD. in China. The tests are non-clinical and relate to product performance, not 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)

This question is not applicable. The "ground truth" for this device (a medical face mask) is established by standardized laboratory test methods (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, 16 CFR Part 1610, ISO 10993). These are objective measurements performed in a laboratory setting, not based on expert interpretation of medical images or patient outcomes.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among experts to establish ground truth in diagnostic studies. The tests conducted for this device are laboratory-based physical and biological performance tests, not diagnostic interpretations requiring expert consensus.

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

This question is not applicable. This document is for a Disposable Medical Face Mask, not an AI-powered diagnostic device, and therefore no MRMC study was performed.

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

This question is not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical performance of the medical face mask is established by standardized laboratory test methods against predefined performance metrics (e.g., Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability, and Biocompatibility tests according to ISO 10993 standards). These are objective measurements rather than interpretations requiring expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This document pertains to the performance testing of a physical medical device (face mask), not an AI algorithm. There is no concept of a "training set" in this context.

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

This question is not applicable, as there is no training set for a physical medical device.

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