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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 is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.

The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.

Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.

The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:

1. Table of acceptance criteria and the reported device performance:

The "Pass" result indicates that the device met the specified acceptance criteria for each test.

The following information is not present in the provided document, as it pertains to AI/ML device studies, which this medical mask submission is not:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.

This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.

Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.

The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.

Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:

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

2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes or dimensions). However, the tests are in accordance with the specified ASTM and ISO standards, which typically define appropriate sample sizes for such tests.
Data provenance: The testing was conducted by Guangdong Kingfa Sci. & Tech. Co., LTD., based in China. The data likely comes from laboratory testing conducted directly by or for the manufacturer. The data is retrospective in the sense that it was collected prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the device. Ground truth for glove testing is established through physical measurements, chemical analysis, and standardized biological tests conducted in laboratories, not by expert consensus of human readers. The "experts" would be the certified laboratory technicians and scientists performing the tests according to the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image reading. The testing for gloves involves objective measurements and standardized protocols.

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-assisted diagnostic device.

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 is based on objective, standardized measurements and laboratory test results defined by internationally recognized standards (ASTM, ISO). For example, a glove has a physical dimension (e.g., length, width), a certain tensile strength, or a specific level of powder residue, as measured by precise instruments and chemical analyses. Biocompatibility (irritation, sensitization, systemic toxicity) is determined by in-vivo/in-vitro assays according to ISO standards.

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. As above, there is no training set for this device.

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The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:

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 exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, pinholes, or biocompatibility). The tests are based on established ASTM and ISO standards, which typically specify sampling plans.

• Data Provenance: The tests were conducted internally by the manufacturer, Guangdong Kingfa Sci.& Tech.Co., Ltd., in China. The documentation implies these were prospective tests conducted on the manufactured product to demonstrate compliance with standards.

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 interpretation of results. The "ground truth" for the performance of examination gloves is based on objective, quantifiable physical and chemical properties measured according to international standards (ASTM, ISO).

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

Not applicable. This is not an AI/ML device requiring human adjudication of qualitative data.

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)

The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11). For example, tensile strength and elongation are measured directly, and biocompatibility is assessed through standardized in-vivo and in-vitro tests with specific endpoints.

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.

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The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).

The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.

For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.

Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)

For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.

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 sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
• Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.

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. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.

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

• Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test 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. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.

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

• Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.

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

• The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.

8. The sample size for the training set:

• Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable due to the absence of a training set.

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The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.

This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.

The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the table of acceptance criteria and reported device performance based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
3. Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
4. 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 concerns a physical medical device (gloves), not an AI/ML powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
6. The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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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.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

The provided document describes the acceptance criteria and the study conducted for "Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs" and "Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs".

Here's a breakdown of the requested information:

1. 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 specify the exact sample sizes (number of gloves or individual tests) used for each non-clinical test. It only states that "Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications."

The data provenance is from non-clinical laboratory testing conducted to established international and ASTM standards. The country of origin of the data is not explicitly stated for each test, but the devices are manufactured by GUANGDONG KINGFA SCI. & TECH.CO., LTD. in Qingyuan, Guangdong, China. The testing appears to be prospective as it was performed to verify the device's compliance.

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 study involves non-clinical performance testing of medical devices (gloves), not a diagnostic algorithm or human-readable data necessitating expert ground truth establishment. The "ground truth" here is determined by the objective measurements and adherence to the specified ASTM and ISO standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For non-clinical device testing, the results are objectively measured 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

There was no MRMC comparative effectiveness study done. This study is for medical gloves, which are physical devices, not an AI or imaging diagnostic tool 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. This study concerns a physical medical device (gloves), not an algorithm or AI.

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

The "ground truth" for this non-clinical testing is based on objective measurements and adherence to established international standards such as ASTM D6319-19, ASTM D6978-05, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, chemical permeation resistance, and biocompatibility of the gloves.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm development study.

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 testing.

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The Medical Protective 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 Protective 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 Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.

This document is an FDA 510(k) premarket notification for a medical protective mask. It does not describe an AI medical device or an MRMC study. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI and human reader improvement, cannot be extracted from this document.

However, I can provide the acceptance criteria and reported performance for the physical and biological characteristics of the medical protective mask based on the provided text.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This table details the performance criteria for the Medical Protective Mask (Model: KF-A F02(N)) based on ASTM F2100 Level 2 standards.

Information Not Applicable or Not Found in the Document:

The provided document is a 510(k) premarket notification for a Medical Protective Mask, which is a physical device, not an AI/software-based medical device. Therefore, the following points related to AI, imaging, and clinical studies are not applicable or not found in this document:

2. Sample size used for the test set and the data provenance: Not applicable for this type of device and testing. The performance tests are laboratory-based, often using standard samples or methods (e.g., bacterial aerosols, synthetic blood).
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 masks is established by standardized laboratory test methods, not expert clinical interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation, not mask performance. The document explicitly states "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on standardized laboratory test methods and established measurement criteria (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862 for fluid resistance, ISO 10993 for biocompatibility).
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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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 is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and 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 metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.

The document provided describes the acceptance criteria and performance of a Medical Surgical Mask (Model: KF-B P05) by Guangdong KINGFA Sci.&Tech.Co.,Ltd. Rather than an AI device being proven to meet acceptance criteria, this is a 510(k) summary for a medical device (a mask) demonstrating substantial equivalence to a predicate device through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against ASTM F2100:2019 Level 1 performance requirements.

Biocompatibility Tests: The device also underwent biocompatibility testing according to ISO 10993-1:2009 for skin contact, with the following results:

• Cytotoxicity: Non-cytotoxic
• Irritation: Non-irritating
• Sensitization: Non-sensitizing

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

The document does not explicitly state the sample sizes used for each non-clinical performance test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the test methods and results.

The testing was performed according to international standards (ASTM and EN for performance, ISO for biocompatibility). The manufacturer is Guangdong KINGFA SCI.&TECH.Co.,Ltd. from China, so it is assumed the tests were conducted in facilities that are likely in China or by labs accredited to these standards. The nature of these tests is prospective as they are conducted specifically for the purpose of demonstrating device safety and effectiveness for regulatory submission.

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 to this type of device. The "ground truth" for a medical surgical mask is established by validated scientific test methods (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE) and regulatory standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility). These methods have predefined criteria for success or failure, not expert consensus as would be used for image interpretation in AI.

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 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with human readers. For this device, objective laboratory tests with defined protocols and metrics determine the performance.

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 submission is for a physical medical device (a surgical mask), not an AI algorithm. Therefore, no MRMC study or assessment of AI assistance was performed or is relevant.

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

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

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

The "ground truth" for the device's performance is established by the standardized test methods and their defined pass/fail criteria. For example:

• Bacterial Filtration Efficiency: Measured quantitatively as a percentage (≥95% is the pass criterion).
• Differential Pressure: Measured quantitatively in mm H2O/cm² (<5.0 mm H2O/cm² is the pass criterion).
• Biocompatibility: Determined by laboratory assessments (e.g., in vitro cell cultures for cytotoxicity, animal models or human patch tests for irritation/sensitization) against predefined biological response levels.

8. The sample size for the training set

This question is not applicable. This is not an AI device, so there is no "training set."

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

This question is not applicable. No training set exists for this type of device.

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