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The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.

The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The proposed device (model: ZSFM 24) is 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 non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Surgical Mask (Models ZSFM23 and ZSFM24)
Manufacturer: Wuhan Zonsen Medical Products Co., Ltd

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For performance tests, three non-consecutive lots were tested for each model (ZSFM23 and ZSFM24). Within each lot, a sample size of 32 was used for each performance test (BFE, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability). For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number of masks, but "the device" was evaluated.
• Data Provenance: Not specified in the provided text (e.g., country of origin for the testing facilities, specific dates). The study appears to be a prospective evaluation of newly manufactured devices/lots, rather than a retrospective analysis of existing data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This device (Surgical Mask) involves performance testing against established industry standards and biological evaluations, not diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is defined by the objective pass/fail criteria of the specified ASTM, EN, and ISO standards.

4. Adjudication Method

• Again, this is not applicable for performance testing of a physical medical device like a surgical mask. Results are determined by standardized laboratory methods and measurements, not by human expert adjudication of subjective findings.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human interpretation (e.g., in radiology). The submitted device is a physical product (surgical mask) whose performance is evaluated against material standards.

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

• Not applicable. This is not an AI algorithm or software device. The "standalone performance" is the direct physical and biological performance of the surgical mask itself, as measured by the specified tests.

7. The Type of Ground Truth Used

• The "ground truth" for the acceptance criteria and evaluation is derived from established international standards and regulatory guidance for medical face masks. Specifically:
  • ASTM F2100-20 (Standard Specification for Performance of Materials Used In Medical Face Masks)
  • ASTM F1862-17 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
  • EN 14683:2019 (Requirements and Test Methods of Differential Pressure of Medical Face Mask)
  • ASTM F2101-19 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
  • ASTM F2299-17 (Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates)
  • 16 CFR Part 1610-2008 (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 "ground truth" is therefore objective, measurable, and defined by these recognized scientific and regulatory benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The masks are physical products subject to direct performance testing.

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

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

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The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.

The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric. The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering. The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100. Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.

The provided document is a 510(k) summary for a Surgical Mask (K222335) and does not describe an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study details, and ground truth establishment for such devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present.

Instead, the document details the performance testing of the surgical mask against established standards for medical face masks. The acceptance criteria are based on ASTM F2100-19 for performance and ISO 10993 for biocompatibility.

Here's a summary based on the provided text for a non-AI/ML device:

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

Notes:

• ¹ Two samples (one sample per lot in two lots among the three lots) did not meet the acceptance criteria for Fluid Resistance at 160mmHg.
• ² Only one data (97.64%) did not meet the acceptance criteria for Particulate filtration efficiency.

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

• For performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability): Three lots, with 32 samples per lot were used. The provenance is not explicitly stated as country of origin, but the manufacturer is Luoyang Sunmed Devices Co., Ltd. from China. These are prospective tests on manufactured devices.
• For biocompatibility tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly mentioned with numerical values like "32 per lot" as in the performance section, but tests were conducted on the proposed device extract. The provenance is not specified.

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 for this type of device. The "ground truth" for a surgical mask's performance is established by standardized physical and biological testing methods (e.g., fluid penetration, bacterial filtration, flammability), not by expert consensus or interpretation of images.

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

This is not applicable as the tests are objective laboratory measurements against predefined physical and biological criteria, not subjective interpretations requiring adjudicated consensus.

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

This is not applicable as the device is a surgical mask and 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 is not applicable as the device is a surgical mask and not an algorithm.

7. The type of ground truth used:

The ground truth is based on standardized test methods and predetermined performance thresholds as defined by standards such as ASTM F2100-19 and ISO 10993 series for medical device performance and biocompatibility.

8. The sample size for the training set:

This is not applicable as the device is a surgical mask and not an AI/ML model that undergoes training.

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

This is not applicable as the device is a surgical mask and not an AI/ML model for which a training set and its ground truth would be established.

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

The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.

Below are the configuration of each model.

GFM 96 - three-layer, flat-pleated with ear loops

GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip

GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield

GFM 88 - three-layer, flat-pleated with ties

GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip

GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield

The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.

The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.

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

The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) Premarket Notification for a Surgical Mask, specifically models GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, and GFM 80, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.

The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K210147). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical testing conducted to show the device meets specific requirements for surgical masks and is equivalent to the predicate.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: For the performance tests (Bacterial Filtration, Differential Pressure, Particulate Filtration, Synthetic Blood Penetration, Flammability), 3 non-consecutive lots were tested, using a sample size of 32 devices per lot.
• Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs were located). It mentions the applicant's address as "JINGZHOU HUBEI, CHINA." The study is a non-clinical study, which typically means lab testing, not patient-derived data, so the terms "retrospective" or "prospective" are not applicable in their usual clinical sense. The tests were performed to demonstrate compliance with recognized standards.

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

• This is a non-clinical device performance and safety study, not a study involving medical imaging or clinical diagnosis where experts establish ground truth.
• The "ground truth" for these tests is defined by the established ASTM, EN, ISO, and CFR standards themselves (e.g., a specific filtration efficiency percentage, a specific pressure drop value, etc.). The tests are quantitative measurements against these predefined objective criteria.
• The document does not mention the number or qualifications of experts involved in "establishing ground truth" in the way one would for diagnostic AI. The expertise would lie in the accredited labs and personnel performing the standardized tests.

4. Adjudication Method for the Test Set

• Not applicable. This is a non-clinical, quantitative performance testing of a physical device against specified standards. Results are direct measurements, not subject to human adjudication or consensus in the way clinical interpretations are.

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 submission is for a surgical mask, a physical medical device, not an AI or diagnostic imaging device that assists human readers. No MRMC study was conducted.

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

• Not applicable. This is a physical device, not an algorithm. The "standalone" performance here refers to the intrinsic physical properties and performance of the mask as measured by the specified tests.

7. The Type of Ground Truth Used

• The "ground truth" for these non-clinical tests are the quantitative performance specifications defined by internationally recognized standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610 for performance, and ISO 10993-5, ISO 10993-10 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this context.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. The "training set" concept is relevant for machine learning/AI models. For device manufacturing, the "training" involves process control and quality assurance to meet specifications, not data-driven model training.

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

• Not applicable for the reasons stated above (physical device, not an AI model). Quality control and manufacturing processes ensure the device is produced to meet the established performance specifications.

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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. The Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.

The provided document is a 510(k) Premarket Notification for a Surgical Mask. It details the device's technical specifications, intended use, and a comparison to predicate devices, along with performance and biocompatibility testing. The document does not describe an AI/ML-driven medical device, but rather a traditional medical device (a surgical mask).

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through physical and performance testing, rather than through a clinical study involving AI/ML performance metrics.

Here's a breakdown of the information that is available related to the device's performance, as per the tables in the document, interpreted as "acceptance criteria" and "reported performance" for a surgical mask:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The document presents performance data for two models of the surgical mask (0868F and 0866F), which align with different performance levels (Level 1 and Level 3, respectively, based on ASTM F2100 standards).

Points 2-9 (Specific to AI/ML Device Study Design) are Not Applicable:

Since this document describes a surgical mask and not an AI/ML device, the following points are not addressed:

• 2. Sample sized used for the test set and the data provenance: Not applicable. Performance is evaluated on physical samples of the mask, not a data test set.
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for a surgical mask is based on standardized physical and chemical tests, not expert interpretation of AI outputs.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for evaluating changes in human diagnostic performance with AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a surgical mask's performance is established by the standardized test methods themselves (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).
• 8. The sample size for the training set: Not applicable. There is no AI model to train.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance for a traditional medical device (surgical mask) based on established performance standards and biocompatibility, rather than a clinical study of an AI/ML device.

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The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 sterile.

The model EH-1 is made of mask body, nose clip, ear loops and nose pad, whit color. The model EH-2 is made of mask body, nose clip, straps and nose pad, green color.

The mask body is manufactured with three layers, the inner and outer layers are made of nonwoven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The straps and ear loops are held in place over the users' mouth and nose by two elastic straps welded to the mask body. It is made of nylon & spandex.

The nose clip in the layers of mask body is to allow the user to fit the mask body around their nose. It is made of polypropylene plastic wrapped metallic wire.

The nose pad which is made by 100% polyurethane is placed between the nose bridge and the mask body to let the user feel comfortable.

The buckle is use to clamp the ear loops and adjust the length and tightness of the mask. It is made of Polypropylene.

The colorant of white (EH-1)is Titanium dioxide, CAS Number is 13463-67-7; and the colorant of green(EH-2) is Pigment Green 7, CAS Number is 1328-53-6.

The EH-1 will be provided in white and the EH-2 will be provided in green. The Surgical Masks are sold sterilized with ethylene oxide gas and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and results for a Surgical Mask (device name). It details non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

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 Data Provenance:

• Sample Size for Physical Performance Tests (e.g., Blood Penetration, BFE, PFE, Delta P): The acceptance criteria explicitly state "≥ 29 samples out of 32 pass". This indicates that 32 samples were likely used for these specific tests for each model (EH-1 and EH-2).
• Sample Size for Biocompatibility Tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The specific sample sizes for these tests are not provided in the document, only the qualitative results.
• Data Provenance: The document states "non-clinical tests were conducted to verify that the subject device met all design specifications." The manufacturer is Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA. The tests appear to be prospective as they were conducted to demonstrate compliance for this specific device submission.

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

• Not applicable. This study involved non-clinical performance testing of a physical device (surgical mask) against established industry standards (e.g., ASTM, EN, ISO, CFR). Ground truth is established by the test methods themselves and their quantifiable outcomes, not by expert consensus or interpretation of medical images/data.

4. Adjudication Method for the Test Set:

• Not applicable. As stated above, this is non-clinical performance testing against objective standards, not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a submission for a surgical mask, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance was performed.

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

• No. This is a physical medical device (surgical mask). There is no algorithm involved.

7. The Type of Ground Truth Used:

• The ground truth for the device's performance is established by objective, quantitative measurements against recognized international standards (ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific test procedures and criteria for evaluating properties like bacterial filtration efficiency, blood penetration resistance, differential pressure, flammability, and biocompatibility.

8. The Sample Size for the Training Set:

• Not applicable. This refers to non-clinical testing of a physical device, not a machine learning model that requires a training set.

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

• Not applicable. See explanation for point 8.

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The 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 masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile.

XX0009 Ear loop Level: Level 1, Level 2 and Level 3
XX0008 Tie-on Level: Level 1, Level 2 and Level 3
XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3
XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3

The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece 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 proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.

The provided text is a 510(k) Summary for Surgical Masks (K212120), focusing on demonstrating substantial equivalence to a predicate device (K160269) through non-clinical testing. It does not describe a study involving an AI (Artificial Intelligence) or medical imaging device, nor does it involve a multi-reader multi-case (MRMC) study. Therefore, many of the requested details, such as human reader improvement with AI assistance, ground truth establishment for AI training/test sets, or the number of experts for adjudication, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, specifically for the surgical masks.

Acceptance Criteria and Device Performance for Surgical Masks (Based on Non-Clinical Tests)

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical tests were conducted to verify that the proposed device met all design specifications. The performance levels (Level 1, Level 2, Level 3) refer to classifications defined by ASTM F2100: 2019 "Standard Specification for Performance of Materials Used in Medical Face Masks."

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

The document does not explicitly state the specific sample size (number of masks or material samples) used for each non-clinical test. These tests are typically conducted on a statistically significant number of samples per batch or according to the specific standard's requirements, but the exact count is not detailed in this summary.

The provenance of the data is that these are non-clinical laboratory test results performed to demonstrate compliance with recognized consensus standards (ASTM, ISO, EN, CFR). The tests were performed for a Chinese manufacturer (Hubei Xinxin Non-woven Co., Ltd.) for submission to the U.S. FDA. The data is implicitly prospective testing conducted specifically for this regulatory submission.

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

Not applicable. These are physical and biological performance tests on a device (surgical masks), not image-based diagnostic tests or AI performance evaluations requiring expert radiologists or similar medical professionals for ground truth establishment. The "ground truth" for these tests is defined by the objective measurement results according to the specified standard methods.

4. Adjudication Method for the Test Set

Not applicable. This is not a study that requires human adjudication of subjective data. The results are based on objective, standardized laboratory measurements.

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

No, an MRMC comparative effectiveness study was not done. This submission is for surgical masks, not an AI or imaging device that would typically involve a human-in-the-loop diagnostic task.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance of the surgical masks is established by objective, standardized laboratory measurements performed according to internationally recognized consensus standards (e.g., ASTM, ISO, EN). For biocompatibility, it's the biological response observed based on in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) assays against defined criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model, and therefore, it does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.

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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. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black

The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.

This document is a 510(k) Summary for a Surgical Mask, submitted to the FDA. It details the non-clinical testing performed to demonstrate that the proposed device is substantially equivalent to a predicate device.

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

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

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

• Sample Size for performance tests: For Fluid Resistance, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, and Flammability, the sample size was "three lots, 32 per lot" for a total of 96 samples per test.
• Data Provenance: The tests were conducted by the submitting company, Guangdong Zhizhen Biological Medical Co., Ltd, which is based in China. The document does not specify if the data is retrospective or prospective, but based on the nature of device testing for 510(k) clearance, it is typically prospective for the purpose of demonstrating performance.

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)

• The document describes non-clinical laboratory testing (e.g., physical properties, filtration efficiency, biocompatibility). It does not involve "experts" establishing ground truth in the sense of medical diagnosis or interpretation of images. The "ground truth" is established by adherence to standardized test methods (e.g., ASTM, ISO, EN standards) and their predefined acceptance criteria. Thus, the expertise lies in the accredited laboratories and personnel performing these specific, standardized tests.

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

• This is not applicable as the study involves standardized laboratory testing against specific criteria, not human interpretation or adjudication of cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI/imaging devices, not for a surgical mask.

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

• This is not applicable. The device is a physical surgical mask, not an algorithm. The performance tests are for the physical properties of the mask (e.g., filtration, fluid resistance).

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

• The "ground truth" for these tests is defined by established international standards and regulations (e.g., ASTM F2100-19, ISO 10993 series, EN 14683, 16 CFR 1610, USP <85>). The performance of the device is measured against the quantitative and qualitative acceptance criteria specified in these standards.

8. The sample size for the training set

• This is not applicable. The submission describes non-clinical testing of a physical device, not an algorithm that requires a training set.

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

• This is not applicable, as there is no training set for a physical device like a surgical mask.

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

The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of 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 elastic ear loops welded to the facemask. The elastic ear loops are made of polyester. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

Here's a breakdown of the acceptance criteria and study information for the Surgical Mask, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical tests conducted to demonstrate that the proposed device meets its design specifications and acceptance criteria. This is primarily a standalone performance study as it evaluates the device's physical and biological properties.

1. Sample sizes used for the test set and data provenance:

   • Fluid Resistance (ASTM F1862-13): "182 out of 182 pass." This indicates a sample size of 182 masks were tested for fluid resistance.
   • For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, specific sample sizes are not explicitly stated for the "Proposed Device" results, but the footnote mentions "Acceptable sampling plans are found in ISO 2859-1 with an acceptable quality limit of 4 %". This implies that standard sampling methods were followed.
   • Biocompatibility: The results (non-cytotoxic, non-irritating, non-sensitizing) are qualitative statements, and specific numerical sample sizes for these tests are not provided in the summary.
   • Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of performance testing for device submission, it's generally prospective as the tests are conducted specifically for the submission.

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

   • Not applicable. This is a non-clinical, laboratory-based performance study, not a study requiring expert consensus for ground truth on patient outcomes or diagnoses. The "ground truth" is defined by the established ASTM and ISO standards and test methodologies.

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

   • Not applicable. This type of adjudication is typically used in clinical studies when interpreting ambiguous cases or disagreeing expert opinions. For objective laboratory tests, the results are quantitative or qualitative assessments against defined criteria, not subject to human adjudication in this sense.

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:

   • No, a MRMC comparative effectiveness study was not done. This device is a surgical mask, and the evaluation focuses on its physical and biological performance characteristics, not on the effectiveness of human readers or AI assistance.

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

   • Yes, a standalone study was done. The non-clinical tests described are evaluations of the device's intrinsic properties and performance, independent of human interaction or interpretation beyond performing the test procedures.

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

   • The ground truth for these non-clinical tests is based on established industry standards and test methodologies (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured against the quantitative and qualitative requirements set forth in these standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The "device" in question is a physical product (surgical mask). The tests evaluate its performance characteristics directly.

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

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

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The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.

The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.

All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.

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.

The proposed device(s) 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 terylene and spandex.

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

Based on the provided text, the device in question is a Surgical Mask, and the submission is a 510(k) premarket notification. This type of submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies for novel AI/ML-driven diagnostics.

Therefore, the requested information regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and standalone algorithm performance is not applicable to this document. This document describes the testing for physical and biological properties of the surgical masks to show they perform as well as a predicate device.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the surgical masks are based on ASTM F2100 Level 2 requirements and other relevant standards.

The study proves the device meets the acceptance criteria as indicated by the "Results" columns. All reported values fall within or exceed the specified acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The studies are non-clinical bench tests performed on the physical masks themselves (e.g., measuring filtration efficiency, pressure drop, flammability, and conducting biocompatibility tests).
The provenance of the data is from non-clinical bench testing performed on the devices manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. in China. The tests are reported as "Nonclinical Test Conclusion," implying they were conducted in a laboratory setting to verify the device's design specifications. The studies are prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance with standards.

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

This concept is not applicable to a submission for surgical masks based on physical and biological performance testing. "Ground truth" in this context refers to the results of standardized laboratory tests performed by qualified personnel using specified methodologies. There is no mention of expert consensus or human interpretation being part of establishing "ground truth" for these performance metrics.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results/labels. The tests are laboratory-based measurements against defined standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (surgical masks).

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

Not applicable. This device is not an algorithm or software. Its performance is evaluated through physical and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and biocompatibility testing (ISO 10993). These are objective, quantitative measurements against predefined criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML 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 this type of device.

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The Surgical Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Medical surgical mask is 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 Sterile.

This document describes the non-clinical testing performed for the HKZ-01 Surgical Mask (subject device) to demonstrate its substantial equivalence to a legally marketed predicate device (Surgical Face Mask, K202843).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Three nonconsecutive lots were tested to demonstrate that the subject device met the standard and the test methodology." (Page 4) Specific sample numbers for each test (e.g., how many masks were tested for fluid resistance) are not provided.
• Data Provenance: Not explicitly stated as country of origin, but the submission is from Nanjing 3H Medical Products Co., Ltd., China. The tests are non-clinical, likely conducted in a laboratory setting. The data is retrospective in the sense that these tests were conducted on completed products prior to submission.

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

• This information is not applicable as the tests are non-clinical, performance-based tests, not requiring expert ground truth for interpretation. The ground truth is defined by the established industry standards (e.g., ASTM, ISO).

4. Adjudication Method for the Test Set

• This information is not applicable as the tests are non-clinical, objective measurements against defined standards, not requiring adjudication by multiple readers or experts.

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

• No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical testing was included in this submission." (Page 5)

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 surgical mask, not an algorithm or AI-powered system. The testing performed is physical and biological performance testing of the mask itself.

7. The Type of Ground Truth Used

• The ground truth for these non-clinical tests is established by objective, quantitative performance criteria defined by recognized national and international standards such as ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR 1610, ASTM F2100-19, and ISO 10993 (various parts).

8. The Sample Size for the Training Set

• This information is not applicable as this is a physical medical device (surgical mask), not an AI/ML algorithm that requires a training set.

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

• This information is not applicable as this is a physical medical device (surgical mask) and does not involve a training set.

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