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The Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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, provided non-sterile.

The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. 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 Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.

The provided document (K210030 510(k) Summary for the Medical Surgical Mask) describes the performance and testing of a medical surgical mask, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for training set, MRMC study, ground truth establishment for training, number of experts for test set ground truth) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the medical device described.

Summary of Device Performance and Testing (Medical Surgical Mask)

The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards. No clinical studies were included.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements for ASTM F2100-19, which defines performance levels for medical face masks. The proposed device includes both Level 2 and Level 3 masks.

Note: The document explicitly states: "The test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask." This confirms that the reported performance metrics meet or exceed the established acceptance criteria for their respective levels.

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

• Sample Size: The specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.) are not explicitly provided in this 510(k) summary. These details would typically be found in the full test reports, which are part of the detailed submission reviewed by the FDA but not included in this public summary.
• Data Provenance: The tests were non-clinical (laboratory-based) and conducted to verify compliance with standards like ASTM F1862/F1862M-17, ASTM F2299/F2299M-03, ASTM F2101: 2019, ASTM F2100: 2019, and ISO 10993. The manufacturer is Tianjin Aoshang Outdoor Equipment Co., Ltd. in China, so it is highly probable that the testing was conducted in laboratories in China or by accredited labs recognized by the manufacturer. The data would be considered retrospective in the context of the 510(k) submission, meaning the tests were completed prior to the submission.

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

This question is not applicable. The device is a medical surgical mask, and its performance is evaluated through objective, standardized laboratory tests (e.g., BFE, PFE, fluid resistance) rather than through subjective interpretation by human experts establishing "ground truth" for diagnostic or AI tasks. The "ground truth" here is the objective measurement obtained by the specific test methodology.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in subjective assessments. The tests conducted for this device are objective, quantitative laboratory 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

This question is not applicable. This submission is for a medical surgical mask, not an AI-powered device. Therefore, no MRMC study or AI-assisted human reader performance evaluation was conducted.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical mask, not an algorithm or software. Its performance is inherent to the product itself, not to a computational model.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective, quantitative measurements derived from standardized non-clinical laboratory tests (e.g., ASTM F2100, F1862, F2299, F2101, etc., alongside ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML or clinical trial ground truth. The "truth" is the measured physical property of the mask.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

This question is not applicable, as there is no training set for this device.

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

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Sample Sizes: The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of masks tested for BFE, PFE, etc.). It only provides the average results for some tests.
• Data Provenance: The tests were conducted to support a submission from Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China. The data is from non-clinical laboratory testing performed on the physical samples of the medical masks. Since these are performance tests of a physical product, they are by definition prospective with respect to the testing itself, i.e., new samples are manufactured and then tested.

3. Number of Experts and Qualifications

• This document describes non-clinical performance testing of a physical device (medical mask). Therefore, it does not involve human expert consensus for establishing ground truth or evaluating diagnostic performance. The "ground truth" here is based on the standardized test methods and their defined outcomes.

4. Adjudication Method

• Not applicable. This is not a study requiring adjudication of expert opinions for ground truth. The tests are objective measurements based on standards.

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

• No MRMC study was done. This document explicitly states: "No clinical study is included in this submission." The testing is purely non-clinical, focusing on the physical and performance characteristics of the mask. An MRMC study would be relevant for diagnostic imaging AI, where human readers interact with AI.

6. Standalone Performance

• The reported performance data (BFE, PFE, Differential Pressure, etc.) represents the standalone performance of the device itself, as measured by standardized laboratory methods. It's important to note that "standalone" in this context refers to the device's inherent physical properties, not an "algorithm only without human-in-the-loop performance" typical of AI devices.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by international and national standard test methodologies (e.g., ASTM F1862/F1862M-17, ASTM F2101-2019, ASTM F2299/F2299M-03, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the procedures and acceptance criteria for classifying the mask's performance.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical mask, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the manufacturing process would be ensuring the production consistently meets quality standards, which is demonstrated by the non-clinical tests on production samples.

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

• Not applicable. As stated above, this is not an AI/ML device requiring a "training set" with established ground truth labels by experts. The performance is assessed against established engineering and safety standards.

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

The Surgical Mask is Blue color, and Flat Pleated type mask, utilizing Ear Loops ' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. Theelastic ear loops are made with Polyester fiber and Polyurethane. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Polyethylene and Metal Wire. The mask is sold non-sterile and are intended to be single-use, dis posable devices and the colorant used for mask is TiO2 + Phthalocyanine Blue BGS + Pigment Violet23.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Surgical Mask (K202640), structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were tested for BFE, PFE, etc.). It only mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted for the purpose of this 510(k) submission.

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

Not applicable. This device is a surgical mask, and its performance is evaluated through standardized laboratory tests (e.g., ASTM, ISO standards) rather than expert review of clinical data. There is no mention of human experts establishing ground truth for these performance metrics.

4. Adjudication Method for the Test Set

Not applicable. Performance is determined by objective laboratory measurements and adherence to specified standard values, not through human adjudication of qualitative assessments.

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 a diagnostic device involving human readers or AI.

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-powered device. The device itself (the surgical mask) is the subject of the standalone performance testing against recognized standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by recognized industry standards and test methods. Specifically:

• ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks, which defines performance levels (e.g., Level 2) based on objective measurements.
• ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials.
• ASTM F2299-03: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates.
• ASTM F1862-17: Standard Test Method for Resistance of Medical Face Masks to Penetration By Synthetic Blood.
• 16 CFR 1610: Standard for the Flammability of clothing textiles.
• ISO 10993-5: 2009: Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
• ISO 10993-10: 2010: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

The device's performance is measured and compared directly against the quantitative or qualitative requirements specified in these 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. The "training" for this type of device involves adherence to manufacturing processes and material specifications.

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

Not applicable. As noted above, there is no training set in the context of this device.

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The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.

The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The provided text describes the acceptance criteria and performance of a Medical Surgical Mask-Non Sterile. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets criteria in an AI/algorithm context. Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific AI-related ground truths, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the device's performance based on the non-clinical tests conducted for this medical device.

Acceptance Criteria and Reported Device Performance

Detailed breakdown of requested information:

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

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 primarily describes non-clinical bench testing for a medical surgical mask. It does not refer to "test sets" in the context of AI/algorithm evaluation but rather samples of the physical medical device used for specific performance tests.
   • Sample Size: Not explicitly stated for each individual test. Standard medical device testing protocols typically specify the number of units to be tested per batch or for regulatory submission, but these details are not provided in this summary.
   • Data Provenance: The tests were performed to demonstrate compliance with international standards (ISO, ASTM, MIL-M-36945C) and US regulations (16 CFR 1610). The manufacturer is SHANDONG T&F NONWOVEN CO., LTD. located in CHINA. The testing was conducted in direct support of their 510(k) submission, implying it's "prospective" in terms of its regulatory purpose, but the specific conduct of the tests themselves would follow standard laboratory practices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. This document pertains to physical device testing against established performance standards, not diagnostic accuracy requiring expert panel consensus/ground truth. The "ground truth" here is the pass/fail criteria defined by the recognized standards (e.g., ASTM F2100, ISO 10993).

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

   • Not Applicable. As per point 3, there's no diagnostic task or expert review requiring an adjudication method.

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 document is about a physical medical device (surgical mask), not an AI algorithm.

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

   • Not Applicable. This document is about a physical medical device (surgical mask), not an AI 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 established international and national standards and regulations (e.g., ISO 10993, ASTM F2100, 16 CFR 1610, MIL-M-36945C). The device's performance is measured against the quantitative and qualitative requirements set forth in these standards. For biocompatibility, it's the absence of cytotoxic, irritant, or sensitizing effects as per the ISO standards. For filtration, it's achieving specific percentage thresholds.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI algorithm.

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

   • Not Applicable. There is no "training set."

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