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Disposable Medical 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 Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene. The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.

This document primarily details the non-clinical testing and substantial equivalence determination for a Disposable Medical Mask (K222545) in comparison to a predicate device (K211454). It is not a study that proves a device meets acceptance criteria through a clinical or reader study involving human interpretation of AI results.

This submission is for a medical mask, which is a physical device, and the "acceptance criteria" discussed are primarily related to its physical and biological performance characteristics (e.g., filtration efficiency, fluid resistance, biocompatibility), not the performance of an AI algorithm. Therefore, many of the requested points, such as those related to AI algorithm performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and performance of the mask itself based on the provided text.

Acceptance Criteria and Device Performance (Applicable to the physical mask device)

The document details the performance testing of the Disposable Medical Mask against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Synthetic Blood Penetration: 32 samples (stated as "32 out of 32 pass at 160 mmHg"). For acceptance, it states "29 samples out of 32 pass (AQL 4%)".
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): Specific sample sizes are not explicitly stated for each test, but standard test methods (e.g., ASTM, ISO) typically specify the number of samples required.
• Data Provenance: Not explicitly stated as retrospective or prospective given this is laboratory testing of a physical product. The manufacturer is Guangzhou Fuzelong Hygiene Material Co., Ltd, China.

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

• Not applicable. This document describes laboratory performance testing of a physical medical device (a mask), not the evaluation of an AI algorithm's diagnostic performance requiring human expert ground truth. The "ground truth" here is the objective measurement of the mask's physical properties against defined standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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

• No. This is not an AI device.

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

• No. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for the mask's performance is based on objective measurements against pre-defined international and national standards (e.g., ASTM, EN, ISO, 16 CFR). For example, "Level 3 pass at ≥98%" for filtration efficiency is the acceptance criterion acting as the "ground truth."

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a "training set."

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

• Not applicable. See point 8.

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The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.

The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and the results of a study demonstrating that the "Disposable Medical Masks" device, manufactured by Hantech Medical Device Co., Ltd., meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 3 nonconsecutive lots were used for testing, with 32 samples for each model of surgical mask for the non-clinical tests.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, Hantech Medical Device Co., Ltd. is based in the PEOPLE'S REPUBLIC OF CHINA. It can be inferred that the testing was conducted for the purpose of this premarket notification, making it prospective in nature relative to the submission.

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

This document describes performance testing for medical masks against established standards. The nature of these tests (e.g., fluid resistance, filtration efficiency, flammability) does not typically involve human expert consensus for "ground truth" establishment in the same way an AI diagnostic algorithm would. The results are obtained through objective physical and biological tests conducted in laboratories. Therefore, information about "experts used to establish ground truth" with specific qualifications is not applicable in this context. The "ground truth" is defined by the technical specifications and criteria within the referenced standards (e.g., ASTM F2100, ISO 10993).

4. Adjudication Method for the Test Set

Given that the tests involve objective measurements against predefined criteria and standards, an adjudication method like "2+1" or "3+1" (typically used for resolving discrepancies in expert interpretations) is not applicable. The results are quantitative and pass/fail based on the physical properties of the masks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is evaluated. This submission is for medical masks, which do not involve human diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone (algorithm-only) performance study was done. The device is a physical medical mask, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these medical masks is defined by established international and national standards and their specific criteria. These include:

• ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks)
• ASTM F1862 (Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood)
• EN 14683 (Medical Face Masks - Requirements and Test Methods)
• ASTM F2101 (Standard Test Method for Evaluating the Bacterial Filtration Efficiency)
• ASTM F2299 (Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates)
• 16 CFR 1610 (Standard for the Flammability of clothing textiles)
• ISO 10993-5 (Biological Evaluation of Medical Devices - Tests For In Vitro Cytotoxicity)
• ISO 10993-10 (Biological Evaluation of Medical Devices - Tests for Irritation and Skin Sensitization)

8. The Sample Size for the Training Set

This submission pertains to a physical medical device (disposable medical masks). There is no "training set" in the context of machine learning or AI algorithms for this type of device. The production of such devices involves manufacturing processes that are validated, but not "trained" in the computational sense.

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

As there is no training set for a physical medical device in the context of an AI/ML algorithm, this question is not applicable. The "ground truth" for manufacturing quality relies on process validation and quality control measures against established product specifications.

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The Disposable Medical 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 Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond 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 strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N) The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical 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 Mask. It is for a physical medical device (mask), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) are not applicable here.

However, I can extract information related to the acceptance criteria and non-clinical testing performed for this medical mask.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fluid Resistance: 32 samples per lot, tested across 3 non-consecutive lots.
• Other Performance and Biocompatibility Tests: Specific sample sizes are not explicitly stated for individual tests other than Fluid Resistance, but are implied to be sufficient for standard test protocols outlined by the referenced ASTM and ISO standards.
• Data Provenance: The tests were conducted to verify that the proposed device met design specifications and complied with listed standards. The data provenance is internal testing performed by the manufacturer (Hubei Wanli Protective Products Co., Ltd.) or contracted laboratories adhering to international standards. The document does not specify country of origin for the test data as it pertains to clinical data, but rather product manufacturing. The testing conducted is non-clinical performance and biocompatibility testing. The data is most likely prospective testing for this device.

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

This is not applicable as the device is a physical medical mask, and the "ground truth" for its performance is established through standardized laboratory testing against objective criteria (e.g., filtration efficiency percentages, pressure differentials, biocompatibility assays), not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set

Not applicable. As above, this is laboratory performance and biocompatibility testing, not human review requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical medical mask, not an AI-powered diagnostic device. No human reader studies (with or without AI assistance) were conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical mask. The concept of an "algorithm" or "human-in-the-loop performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE, ISO 10993 for biocompatibility). The results are compared against predefined numerical acceptance criteria.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a "training set."

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

Not applicable. There is no training set for this type of device.

Ask a specific question about this device

The Disposable Medical 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. It is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device. This product contains no components made from natural rubber latex.

This document is a 510(k) premarket notification for a medical device: a Disposable Medical Mask (K212826). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a set of acceptance criteria through a clinical study that uses AI or human readers for diagnosis. Therefore, several aspects of your request (related to AI, human readers, ground truth establishment for a training set, the number of experts, and adjudication methods for a test set) are not applicable to the content provided.

However, I can extract the acceptance criteria and performance data for the physical properties and biocompatibility of the medical mask, as these are the "device performance" aspects evaluated in this submission for regulatory clearance.

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

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

The document presents performance criteria for the Disposable Medical Mask based on established ASTM and EN standards for medical face masks.

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

• Sample Size for Test Set: The document indicates specific sample sizes for certain tests, e.g., "31 out of 32 pass" for fluid resistance. This implies a sample size of 32 masks for that particular test. Other tests, such as BFE, PFE, and Differential Pressure, typically involve multiple measurements across a sample of materials/masks, but specific sample numbers (like 'n=X') are not explicitly stated for each test beyond the fluid resistance.
• Data Provenance: The tests are conducted for the purpose of a US FDA 510(k) submission. The manufacturer is Jiangsu Nanfang Medical Co., Ltd. from Jiangsu Province, China. The testing itself is non-clinical, involving laboratory assessments of physical and biological properties. The document does not specify whether the data was retrospective or prospective in the sense of a clinical trial; these are manufacturing and materials tests conducted on samples of the device.

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. The "ground truth" for a medical mask in this context refers to its physical and biocompatibility properties as measured by standardized laboratory methods (e.g., how much fluid it resists, its filtration efficiency). These are objective measurements, not subjective interpretations by human experts like radiologists.

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

This is not applicable. As the ground truth is established through objective laboratory testing rather than human interpretation, there's no need for an adjudication process involving 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

This is not applicable. This submission is for a disposable medical mask, a physical barrier device, and does not involve AI assistance, image interpretation, or human reader studies.

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

This is not applicable. There is no algorithm or AI involved in this device.

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

The "ground truth" for the device's performance is established through measurements against recognized international consensus standards and test methods. For example:

• Performance: ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862/F1862M-17 for fluid resistance, EN 14683:2019 for differential pressure, and 16 CFR 1610 for flammability.
• Biocompatibility: ISO 10993 series (ISO10993-5 for cytotoxicity, ISO10993-10 for sensitization and irritation).

These standards define the methodology for determining if the device's material properties meet specified safety and performance benchmarks.

8. The sample size for the training set

This is not applicable. The device is a physical product (medical mask) and does not involve AI or machine learning models that require a "training set" of data.

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

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

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The surgical face masks (Ear loops) 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, provided non-sterile.

The Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.

The provided document (K210222) is a 510(k) premarket notification for a Disposable Medical Mask. This type of device is a Class II medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device (K160269) through performance testing against established standards for medical masks, rather than a clinical study involving human subjects or AI algorithm validation data.

Therefore, many of the requested points, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "training set establishment," etc., are not applicable to this specific submission. The "acceptance criteria" here refer to meeting the performance requirements for physical properties of the mask as per recognized standards (e.g., ASTM F2100-19), not diagnostic accuracy or clinical outcomes assessed by an algorithm.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily derived from standard test methodologies for medical face masks.

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

The document does not specify the exact sample sizes (number of masks) used for each individual performance test (e.g., how many masks were tested for BFE). However, these are standard laboratory tests typically performed on a statistically relevant sample size of units from a production batch to ensure consistency. The provenance of the data is from non-clinical laboratory testing, likely conducted in China, as the manufacturer is based in China. The testing is retrospective in the sense that it's performed on manufactured samples for regulatory submission. It is not clinical data.

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

Not applicable. The "ground truth" for the performance tests of a medical mask (e.g., BFE, PFE, fluid resistance) is established by the standardized test methodologies themselves and the physical measurements obtained. It does not involve expert readers or clinical interpretation like in diagnostic AI.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication step in these physical 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 a physical medical device (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 medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device, which is a physical barrier, is defined by its measured physical performance characteristics as specified by internationally recognized standards (e.g., ASTM F2100-19, EN 14683). This includes:

• Bacterial Filtration Efficiency (BFE)
• Particulate Filtration Efficiency (PFE)
• Fluid Resistance
• Differential Pressure (Breathability)
• Flammability
• Biocompatibility (Cytotoxicity, Irritation, Sensitization)

8. The sample size for the training set

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

Ask a specific question about this device

The Disposable Medical 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 Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.

50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.

The document describes the acceptance criteria and performance of the Disposable Medical Mask (Model: RYSM001) manufactured by Yangzhou Runyi Arts & Crafts CO., LTD. It is a 510(k) summary demonstrating substantial equivalence to a predicate device (Single-use Medical Face Mask, K203591 from Conod Medical Co., Limited).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flame Spread):
  • Sample Size: 3 non-consecutive lots, with 32 samples per lot.
  • Data Provenance: The tests were conducted internally by the manufacturer or a contracted testing facility as part of the premarket notification (K203112) for the proposed device (Disposable Medical Mask, RYSM001). The data comes from non-clinical bench testing. The country of origin for the data is implicitly China, given the manufacturer's address. It is retrospective data collected for submission.
• For Biocompatibility tests (Cytotoxicity, Sensitization, Irritation):
  • The document implies that these tests were conducted on the proposed device to meet the ISO 10993 standards, indicating testing of the device materials. Specific sample sizes for these tests are not provided in the summary but are generally conducted on material extracts or actual device materials according to the standard.

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, bench-top performance and biocompatibility testing of a medical mask. It does not involve human expert adjudication or ground truth establishment in the way this question typically refers to it (e.g., for AI/image analysis studies). The "ground truth" for these tests are the established standards and their predefined pass/fail criteria, as determined by the scientific community and regulatory bodies. Therefore, no human experts were used to establish ground truth for this device in the context of the provided document.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical bench testing against established performance standards, there is no human adjudication or consensus method like 2+1 or 3+1. The results are quantitative measurements compared against predefined thresholds.

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

No. This document pertains to the 510(k) submission for a physical medical device (mask) based on non-clinical performance and biocompatibility testing. It specifically states "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not conducted.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on established international and national standards for medical face masks and biocompatibility:

• Performance Standards: ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36945C, 16 CFR 1610. These standards define the test methodologies and the acceptance criteria (e.g., minimum filtration efficiency, maximum differential pressure, specified fluid resistance).
• Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). These standards provide protocols for evaluating the biological response to medical devices and define acceptable limits for these biological effects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product validated through bench testing.

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

Not applicable. As there is no training set, there is no ground truth to be established for it.

Ask a specific question about this device

The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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.

Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.

Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

This document is a 510(k) summary for a Disposable Medical Mask (Model: k0450). It focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a medical device (surgical mask), not a software or AI device. Therefore, the concepts of human readers, AI assistance, effect size, training sets, and ground truth establishment in the context of AI/ML models are not applicable to this document.

The acceptance criteria and performance data pertain to the physical characteristics and barrier performance of the surgical mask.

1. Table of acceptance criteria and the reported device performance

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

• Fluid Resistance Performance (ASTM F1862): The test involved 32 samples as indicated by the acceptance criteria and reported performance ("29 Out of 32 pass" and "32 out of 32 pass").
• Other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability, Differential Pressure): The sample sizes for these specific tests are not explicitly stated in the provided text, beyond the percentage or class reported.
• Data Provenance: The tests were conducted by a lab (implied by "lab bench testing") to evaluate the safety and effectiveness of the device. The specific country of origin of the testing lab is not mentioned, though the manufacturer is based in China. The tests are described as "non-clinical tests" and not related to human subject data, therefore, "retrospective or prospective" doesn't apply in the context of clinical trials.

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

N/A. This is a physical medical device (surgical mask) evaluated by laboratory bench testing against established performance standards. "Experts" to establish a ground truth in the sense of clinical interpretation or diagnosis are not relevant for this type of testing. The "ground truth" is defined by the objective measurement standards referenced (e.g., ASTM F1862, ASTM F2101).

4. Adjudication method for the test set

N/A. As this involves objective physical testing against defined standards, an adjudication method for reconciling expert opinions is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

N/A. An MRMC study is relevant for comparing the performance of readers (e.g., clinicians) with and without assistance from a diagnostic tool or AI. This submission is for a physical medical device (surgical mask) and does not involve human readers in its performance evaluation as described.

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

N/A. This is not a software or algorithm-based medical device.

7. The type of ground truth used

The "ground truth" for the performance of the Disposable Medical Mask is based on objective measurements against established performance standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for bacterial filtration efficiency, 16 CFR 1610 for flammability). These standards define the criteria for a "Level 2 barrier" mask.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. This is not an AI/ML device that requires a training set or ground truth established for it.

Ask a specific question about this device

Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and study information for the "Disposable Medical Mask," based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The non-clinical testing was performed using 3 nonconsecutive lots with a total of 96 samples evaluated.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer is Dong Guan Kinyet Metal Products Co., Ltd. in China, it's highly probable the testing was conducted prospectively in a laboratory, potentially in China or a facility used by the manufacturer.

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

This information is not applicable (N/A) for this type of device and study. The "ground truth" for the performance criteria of a medical mask (like filtration efficiency, fluid resistance, biocompatibility) is established through standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus on cases. The results are objective measurements.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is N/A for this type of device and study, as the tests are objective measurements based on standardized protocols, 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

This information is N/A. This document describes the performance of a physical medical device (a mask), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This information is N/A. This is a physical medical device, 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 established by objective, quantitative measurements obtained through adherence to recognized international and national standards (ASTM, ISO, 21 CFR). For example:

• Fluid resistance is measured by the ability to resist penetration by synthetic blood at a certain pressure.
• Bacterial filtration efficiency is measured by the percentage of bacteria filtered.
• Biocompatibility (cytotoxicity, irritation, sensitization) is assessed through standardized in-vitro and in-vivo tests that yield measurable results (e.g., cell viability, observed reactions).

8. The Sample Size for the Training Set

This information is N/A. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This information is N/A as there is no training set.

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The Disposable Medical 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. It is intended for adults only (greater than 21 years of age).

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.

The provided document is a 510(k) summary for a disposable medical mask. It details the device's technical characteristics and performance testing against established standards, primarily for determining substantial equivalence to a predicate device.

Here's the information requested based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is seeking to meet Level 2 classification according to ASTM F2100-19.

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 for each specific performance test (e.g., the number of masks tested for BFE or PFE). For the Fluid Resistance test, it is stated that "32 out of 32 pass at 120mmHg," implying a sample size of 32 for that specific test.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the device manufacturer is in China: "TUOSHENG PROTECTIVE PRODUCTS (NINGBO) CO.,LTD... Zhejiang Province, CHINA".

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 evaluations are based on objective, standardized laboratory tests (e.g., ASTM, ISO standards) for material performance and biocompatibility, not on expert interpretation of medical images or clinical data. There is no concept of "ground truth" established by experts in this context.

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

This information is not applicable as the evaluation is based on objective laboratory testing against pre-defined numerical and qualitative criteria, not on subjective assessments requiring adjudication.

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

No such study was performed or is relevant to this device. This document describes the testing of a medical mask, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a physical medical mask, not an 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, quantitative performance specifications outlined in the referenced international consensus standards (ASTM, EN, ISO, 16 CFR). For example, a BFE of ≥98% is the objective standard (ground truth) for a Level 2 mask in that particular test.

8. The sample size for the training set

This information is not applicable. The device is a physical medical mask. There is no "training set" as it is not a machine learning model.

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

This information is not applicable for the reasons stated in point 8.

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The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

The Disposable medical mask is flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clip design for fitting the facemask around the nose. The Disposable medical mask is only one model: WSKZ-001 and the color is blue. The Disposable medical mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue, CAS number: 147-14-8), and the middle layer is made of melt blown fabric. Ear loops, which is held to cover the users' mouth and nose by two Ammonium nylon elastic bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the Disposable medical mask is in the middle layer of Disposable medical mask to allow the user to fit the Disposable mask around their noses, which is made of Polypropylene and metallic iron. The Disposable medical mask is sold non-sterile and is intended to be single use, and the intended environment is professional healthcare facility environment. The shelf life of each Disposable medical mask is 2 years. The dimensions of each Disposable medical mask are length 175mm and width 95mm. The dimension of nose clip is length 100mm, and the ear loop is length 170mm.

The provided text describes the acceptance criteria and performance data for a medical mask (K203388) seeking FDA clearance, primarily through comparison to a predicate device (K153409).

Here's the breakdown of the information requested:

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)

• Sample Size for performance tests: 32 samples were used for each of the bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, and flame spread tests.
• Sample Size for biocompatibility tests: The document refers to "the subject device extract" for cytotoxicity, irritation, and sensitization tests, implying a sufficient sample was prepared according to the respective ISO standards. No specific number of devices or extracts is provided.
• Data Provenance: The document does not explicitly state the country of origin of the testing data or whether it was retrospective or prospective. However, the submitter, Everwin Toys (Dongguan)., Ltd., is located in China, and the application correspondent is in Guangzhou, China. The testing standards (ASTM, EN, ISO) are international.

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 device is a medical mask and the evaluation involves objective performance metrics (e.g., filtration efficiency, pressure, flammability) and biocompatibility, not diagnostic interpretation. Therefore, there are no "experts" in the sense of clinicians or radiologists establishing a "ground truth" for a test set. The ground truth is established by the results of standardized laboratory tests by qualified personnel following the specified ASTM, EN, and ISO methodologies.

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

Not applicable. The evaluation is based on objective laboratory measurements against predefined thresholds, not subjective interpretation requiring adjudication 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

Not applicable. This is a medical mask, not an AI-powered diagnostic device. No human reader or AI assistance studies were performed or are relevant to this type of device.

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

Not applicable. This is a medical mask, not an algorithm or software device.

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

The ground truth for the performance and biocompatibility tests is established by the results obtained from adherence to recognized international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These are objective, quantitative measurements and qualitative assessments (e.g., non-cytotoxic) conducted in a laboratory setting.

8. The sample size for the training set

Not applicable. This is a physical medical device (mask), not an AI algorithm that requires a training set.

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

Not applicable. As
described above, this is a medical mask and does not involve AI algorithms or training sets.

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