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The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided FDA 510(k) summary for the Azur Medical Company Inc. Medical Surgical Mask (K231719) details the acceptance criteria and study results for the device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask with two types: Level 2 and Level 3, based on ASTM F2100-19.
The table below combines information from the "VII Comparison of technological characteristics with the predicate device" and "VIII Summary of Non-Clinical Tests" sections. Note that for some performance characteristics, the specific numerical results are given in comparison to the predicate, while for others, only "Pass" is stated against the acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many masks were tested for PFE, BFE, etc.). It only reports the overall "Test results" as "Pass" or an average value for the proposed device.

The data provenance is not specified in terms of country of origin, but the testing would typically be performed by accredited labs. The studies described are non-clinical (laboratory-based performance testing and biocompatibility testing), not clinical trials, so the terms "retrospective" or "prospective" do not apply in the same way they would for patient data.

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 to this document. The "ground truth" for non-clinical testing of a surgical mask is established by validated standardized test methods (e.g., ASTM, ISO standards) and their defined acceptance criteria. It does not involve expert consensus in the way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

This is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently review cases and then resolve discrepancies. Non-clinical performance tests follow predefined protocols and acceptance 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

This is not applicable to this document. This submission is for a physical medical device (surgical masks), not an AI/software as a medical device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant.

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

This is not applicable to this document. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth for this device's evaluation is based on standardized test methods and their defined performance criteria, primarily from ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

• Particulate Filtration Efficiency: ASTM F2299/F2299M-03
• Differential Pressure: ASTM F2100: 2019
• Bacterial Filtration Efficiency: ASTM F2101: 2019
• Flammability: 16 CFR Part 1610
• Synthetic Blood Penetration Resistance: ASTM F1862/F1862M-17
• Biocompatibility: ISO 10993 series (ISO10993-5, ISO10993-23, ISO10993-10)

These standards define the methodology and the quantitative or qualitative criteria for "passing" the test, which serves as the ground truth.

8. The Sample Size for the Training Set

This is not applicable to this document. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML device, so there is no training set in this context.

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

This is not applicable to this document, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device

Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical 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.

Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece. These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.

The provided text describes the acceptance criteria and performance of a Medical Surgical Mask but does not involve an AI-powered device or a study comparing AI assistance with human readers. Therefore, the questions related to AI effects, training data, and expert adjudication are not applicable.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device, "Medical Surgical Mask," was tested according to various standards (ASTM, EN, CFR, ISO). The results are categorized by Level 1 and Level 3 barrier requirements as per ASTM F2100.

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

• Fluid Resistance:
  • For ZKM-U02 (Black) and ZKM-U05 (Black): Not explicitly stated, but implies passing for all samples tested.
  • For ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U06 (Blue), ZKM-U07 (White): 32 samples were tested for each model, with 31 out of 32 passing based on the acceptance criteria.
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The sample size for these tests is not explicitly stated in the provided text. The results are reported as overall percentages or averages.
• Biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation): Sample sizes are not explicitly stated for these tests, though they typically involve a specific number of cells (cytotoxicity) or animals (sensitization/irritation).
• Data Provenance: The study is "non-clinical" and likely conducted in a laboratory setting. The country of origin for the data is not specified beyond the manufacturer's location in Guangzhou, China. The studies are assumed to be prospective tests performed on the manufactured devices.

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

Not applicable. This is not a study requiring expert interpretation of results to establish ground truth (e.g., medical imaging diagnosis). The ground truth is established by objective measurements against standardized test methodologies (e.g., ASTM, ISO).

4. Adjudication method for the test set

Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method. The tests are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical surgical mask, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth is based on objective measurements against established international and national standards and methodologies, such as ASTM F1862-17 for fluid resistance, ASTM F2299-17 for particulate filtration efficiency, ASTM F2101-19 for bacterial filtration efficiency, EN 14683:2019+AC:2019 Annex C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 series for biocompatibility.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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 Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical 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 Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) premarket notification for a Medical Surgical Mask (Planar type). It focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. The performance data presented is for the device itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML clinical studies are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask, and its performance is evaluated against parameters specified in medical device standards such as ASTM F2100. The acceptance criteria and reported performance are for the physical properties and barrier effectiveness of the mask.

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

The sample size for performance testing was 32 units per lot, across 3 non-consecutive lots. This makes a total of 96 units tested for each performance characteristic.

Data provenance is from non-clinical tests conducted by Hunan Chopard Medical Devices Co., Ltd., based in Hunan Province, China. The tests are retrospective to the manufacturing process, as they are performed on finished product lots.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The tests are laboratory-based measurements of physical and biological properties.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for these non-clinical, objective tests. The results are quantitative measurements against predefined 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

Not applicable. This is not an AI/ML device, and no human reader studies or MRMC studies were performed.

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

The "ground truth" for the device's performance is established by validated laboratory testing methods against published international and national standards (e.g., ASTM F2101, EN 14683, ASTM F1862, ISO 10993). These standards define objective, measurable criteria for the performance of medical surgical masks.

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. As there is no AI/ML component, there is no training set or ground truth in that context.

Ask a specific question about this device

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).

The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.

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

The requested information pertains to a medical surgical mask, which is a physical device, not an AI/ML powered device. Therefore, acceptance criteria and study details relevant to AI/ML powered devices are not applicable.

However, based on the provided document, I can extract the acceptance criteria and performance data for the physical medical surgical mask for Level 1 and Level 3 performance, as well as biocompatibility testing.

Here's the relevant information about the acceptance criteria and the study that proves the device meets these criteria, focusing on the available context for a physical medical surgical mask:

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

Medical Surgical Mask (Level 1)

Medical Surgical Mask (Level 3)

Biocompatibility Testing

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

• Sample Size: For the performance tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to penetration by synthetic blood, and Flame Spread), the reported sample size is 32/32 Passed, which implies 32 samples were tested for each performance criterion. The number of samples for biocompatibility tests is not explicitly stated but would typically involve biological samples.
• Data Provenance: Not explicitly stated in terms of country of origin. The submitter is "GUANGDONG KINGFA SCI.&TECH. CO., LTD." from China. The tests are non-clinical (laboratory-based) performance tests, not human data. The tests are prospective in nature, as they are performed on manufactured masks to ensure they meet standards.

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 is not applicable for this type of device. The "ground truth" for the performance tests is established by adhering to recognized international standards (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610, and ISO 10993 series for biocompatibility). These standards define the test methodologies and pass criteria. The testing would be performed by qualified laboratory technicians in accordance with these standards.

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

• Not applicable. The tests performed are objective, quantitative laboratory tests with defined pass/fail criteria from international standards. There is no subjective interpretation requiring expert adjudication in the manner of medical image analysis.

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 (mask), not an AI/ML powered device, and therefore does not involve human readers interpreting output or AI assistance.

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

• Not applicable. This is a physical medical device without any algorithm.

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

• The "ground truth" for this device's performance is defined by adherence to established international standards and their specified methodologies and acceptance limits. For example, the Bacterial Filtration Efficiency testing is conducted according to ASTM F2101-14, and biocompatibility according to ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML model, so 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 device, this question is irrelevant.

Ask a specific question about this device

The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

The provided text describes the acceptance criteria and performance of a Medical Surgical Mask (Model: JM92, JM92B) based on non-clinical testing for FDA 510(k) clearance, not a study involving human readers or AI. Therefore, I cannot provide information on points 2, 3, 4, 5, 8, and 9 as they are not applicable to this type of device submission.

Here is the information from the document related to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to non-clinical performance testing of a physical device (surgical mask), not a test set of data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance testing is established by standardized test methods and laboratory results, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.

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 for a surgical mask, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a surgical mask, not an algorithm.

7. The type of ground truth used:
For the performance tests (bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, flame spread), the "ground truth" is defined by the requirements of the specific ASTM and EN standards used for testing (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610). For biocompatibility, the "ground truth" is defined by the ISO 10993 series of standards (ISO 10993-5 and ISO 10993-10). The device is deemed to meet the acceptance criteria if its measured performance falls within the specified limits of these standards.

8. The sample size for the training set: Not applicable. This is for a physical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 as sterile.

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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 nose piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" 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

The document does not explicitly state the total sample size for the entire test set in a singular number. However, it indicates the sample size for specific tests per lot:

• Fluid Resistance: 32 samples per lot (tested against 3 lots).
• Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: The results are presented for 3 distinct 'Lots' (Lot 1, Lot 2, Lot 3). While the exact number of samples per lot for these tests isn't always explicitly stated (except for fluid resistance), the presentation implies multiple measurements per lot.
• Biocompatibility: The sample size for biocompatibility tests (cytotoxicity, irritation, sensitization) is not specified.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD is located in China, it's highly probable the testing was conducted there.

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 in the document. The tests performed are objective, quantitative laboratory measurements (e.g., filtration efficiency, fluid resistance) based on established ASTM and military standards, not subjective assessments requiring expert consensus on a "ground truth" (like image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective assessments requiring an adjudication method among experts.

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 and no AI component mentioned. This document describes the performance testing of a physical medical device (a surgical mask), not an AI-powered diagnostic tool. Therefore, effects on human reader performance with or without AI assistance are not relevant.

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

There was no standalone (algorithm only) performance study done, as this product is a physical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests directly stems from standardized laboratory test results against predefined acceptance criteria. For example:

• For filtration efficiency, the ground truth is the measured percentage of particles/bacteria filtered.
• For fluid resistance, the ground truth is whether the sample passed or failed at a specific pressure.
• For biocompatibility, the ground truth is the biological response observed in the in vitro or in vivo tests.

This is based on objective measurements and established scientific methods, not expert consensus, pathology, or outcomes data in the traditional sense of clinical studies.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of testing a physical medical device like a surgical mask, as there is no algorithm or model being trained.

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

This information is not applicable and not provided, as there is no training set for this type of device submission.

Ask a specific question about this device

The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided document is a 510(k) premarket notification for a Medical Surgical Mask. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the request asks for information regarding an AI/Software as a Medical Device (SaMD) study, specifically about acceptance criteria, ground truth establishment, sample sizes for training and testing, expert qualifications, and potential MRMC studies.

The provided document is NOT for an AI/SaMD device. It is for a physical medical device (a surgical mask) and therefore does not contain any of the information requested about AI/SaMD acceptance criteria or study methodologies.

Therefore, I cannot fulfill the request using the provided text. The document discusses:

• Acceptance Criteria (for a physical surgical mask): These are performance standards like Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flame Spread, as well as Biocompatibility.
• Device Performance: The document states "Passed" for all the listed performance tests against the specified acceptance criteria for Level 2 and Level 3 masks.
• Study That Proves the Device Meets Acceptance Criteria: This is the "Non-Clinical Test Conclusion" section (pages 4-5), where various physical and biological tests were performed according to recognized standards (e.g., ASTM F2101, EN14683, ASTM F1862, 16CFR Part 1610, ISO 10993).

To explicitly address the numbered points in the prompt based on the provided document (even though it's not an AI/SaMD):

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

   Performance Testing	Purpose	Acceptance Criteria for Level 2 Barrier	Acceptance Criteria for Level 3 Barrier	Result
   Bacterial Filtration Efficiency ASTM F2101	Measure bacterial filtration efficiency	≥98%	≥98%	Passed
   Differential Pressure (mm H2O/cm2)	Determine breathability of a mask	<6.0 H2O/cm²	<6.0 H2O/cm²	Passed
   Sub-micron Particulate Filtration Efficiency ASTM F2299/F2299M-03	Measure initial particle filtration efficiency	≥98%	≥98%	Passed
   Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017	Evaluate the resistance to penetration by impact of small volume of synthetic blood	120 mmHg	160 mmHg	Passed
   Flame spread 16CFR Part 1610-2008	Response of materials to heat and flame	Class I	Class I	Passed

   Biocompatibility Acceptance Criteria and Results:

   Biocompatibility Evaluation	Biological Effect	Standard	Results
   	Cytotoxicity	ISO 10993-5	Not cytotoxic
   	Sensitization	ISO 10993-10	Non sensitizing
   	Irritation	ISO 10993-10	Negligibly irritating

2. Sample sizes used for the test set and the data provenance: The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE). It also does not specify the country of origin of the data or whether the testing was retrospective or prospective, though it implicitly describes a prospective testing process for compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the type of device. The "ground truth" for a surgical mask's performance is established by standardized test methodologies and equipment, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance testing of a physical device.

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 not an AI/SaMD, so no MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is determined by adherence to established, quantitative non-clinical testing standards and their respective measurement methods. For biocompatibility, it's based on biological responses in standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set: Not applicable. There is no AI/ML model for this physical device that would require a "training set."

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.

The document provided pertains to a 510(k) premarket notification for a Medical Surgical Mask. It demonstrates substantial equivalence to a predicate device based on non-clinical performance testing. The device is a "Medical Surgical Mask" (K212867) from Nanchang Kanghua Health Materials Co., Ltd. and its predicate device is "Disposable Surgical Face Mask" (K153496) from Xiantao Rayxin Medical Products Co., Ltd.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and 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)

• Test Set Sample Size: For the performance tests (BFE, Delta-P, PFE, Flammability), the tests were conducted on 3 non-consecutive lots, using a sample size of 32 per lot. For the synthetic blood penetration test, it was 3 non-consecutive lots tested, with the outcome reported as 32 out of 32 passing at 120mmHg, implying 32 samples per lot were used or observed.
• Data Provenance: Not explicitly stated regarding the country of origin of the data, but the manufacturer is Nanchang Kanghua Health Materials Co., Ltd. in China, so it's highly probable the testing was conducted in China or by a contracted lab that sent the data to the manufacturer. The tests are prospective as they were conducted on the subject device to fulfill regulatory requirements for its 510(k) submission.

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

• This document describes non-clinical performance testing of a medical surgical mask. The "ground truth" for such tests is established by standardized laboratory test methods (e.g., ASTM, EN, CFR standards), not by human experts interpreting results. Therefore, no "experts establishing ground truth" in the diagnostic sense are involved. The results are quantitative measurements against predefined criteria.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of medical images or symptoms, where discrepancies between initial readers might need to be resolved. This document details laboratory-based performance testing of a physical product.

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 submission for a medical surgical mask, which is a physical product, not an AI-powered diagnostic device or software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This is a physical medical device (mask), not an algorithm or AI system.

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

• The "ground truth" here is determined by objective measurements obtained through standardized laboratory test methods (e.g., measuring filtration efficiency, differential pressure, resistance to synthetic blood, and flammability according to specified ASTM, EN, and CFR standards). For biocompatibility, it's based on the results of in vitro cytotoxicity, skin sensitization, and skin irritation tests following ISO standards.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning 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 medical device.

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The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 medical surgical 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 text describes the performance criteria and testing for a Medical Surgical Mask to demonstrate its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: For performance tests, the number of samples varied by test:
  • Bacterial filtration efficiency: 32 samples
  • Differential pressure: 32 samples
  • Sub-micron particulate filtration efficiency: 32 samples
  • Resistance to penetration by synthetic blood: 32 samples
  • Flame spread: 32 samples
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only refers to "Non-Clinical Test Conclusion."

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

• Not Applicable: For this type of medical device (surgical mask), the "ground truth" is established through standardized laboratory testing against objective criteria, not through expert consensus or interpretation of medical images. The tests listed are objective physical and microbiological measurements.

4. Adjudication Method for the Test Set:

• Not Applicable: As the "ground truth" is established by standardized test methods with objective pass/fail criteria, an adjudication method in the sense of multiple expert reviews is not relevant. The results are based on the direct output of the specified ASTM and EN 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:

• Not Applicable: This device is a physical surgical mask and does not involve AI or human "readers" interpreting data. Therefore, an MRMC study is not relevant.

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

• Not Applicable: This device is a physical surgical mask and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• The ground truth for the performance criteria is based on standardized laboratory test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993-1/5/10). These methods define objective parameters and thresholds for acceptable performance.

8. The Sample Size for the Training Set:

• Not Applicable: This device is a physical product, not an AI or machine learning model, so 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 device, this question is not applicable.

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