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The Disposable surgical masks are intended to be worn to protect 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 surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.

Here's an analysis of the requested information based on the provided text:

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

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

• Sample Size: For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, "3 non-consecutive lots tested" were used. The number of individual masks tested within each lot is not specified, except for Fluid Resistance where "29 out of 32" suggests 32 samples were tested per lot for that specific test.
• Data Provenance: The tests were conducted by the manufacturer, Xiamen Blue Star Enterprise Co., Ltd., China. The document does not specify if the data is retrospective or prospective, but it's generated for the purpose of this 510(k) submission, suggesting it's newly generated for regulatory approval.

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

This section is not applicable to this document. The device in question is a physical product (surgical mask), and its performance is evaluated through standardized laboratory tests (e.g., filtration efficiency, fluid resistance) rather than through expert interpretation of medical images or other data where a "ground truth" would be established by human experts. The "ground truth" here is the objective measurement of the physical properties of the mask.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where discrepancies need to be resolved. This document details laboratory performance testing of a physical product.

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

This section is not applicable. This document describes the clearance of a physical medical device (surgical mask), not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.

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

This section is not applicable. This is not an algorithm or software device.

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, standardized laboratory test methods. Examples include:

• ASTM F1862 for fluid resistance.
• ASTM F2299 for particulate filtration efficiency.
• ASTM F2101 for bacterial filtration efficiency.
• MIL-M-36954C (or EN 14683) for differential pressure.
• 16 CFR 1610 for flammability.
• ISO 10993-5 and -10 for biocompatibility (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train machine learning models. This document describes a physical medical device, not a machine learning algorithm.

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

This section is not applicable for the same reasons as #8.

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The Disposable 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 Disposable 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(s), provided non-sterile.

Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which 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 face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.

The provided document is a 510(k) Premarket Notification for a Disposable Surgical Mask (K212944). It describes the device, its intended use, and a comparison with a predicate device, along with non-clinical test results.

However, the questions you've asked are typically relevant to the validation of Artificial Intelligence (AI)/Machine Learning (ML) medical devices, particularly those that involve image analysis, diagnosis, or risk prediction. This document is for a physical medical device (surgical mask) and the submitted information pertains to its physical performance characteristics, not its performance in an AI/ML context.

Therefore, many of your specific questions, such as those related to:

• Ground truth establishment by experts
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Training set size and ground truth establishment

are not applicable to the context of this 510(k) submission for a surgical mask. The document does not involve AI/ML.

I can, however, extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for the surgical mask, based on the provided text.

Acceptance Criteria and Device Performance for Disposable Surgical Mask (K212944)

The device in question is a Disposable Surgical Mask, and its performance is evaluated against established physical and biological standards for medical masks.

Here's a summary tailored to 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 Physical Performance Tests:
  • Fluid Resistance (ASTM F1862): 32 samples were tested to achieve the acceptance criteria of "29 out of 32 pass". The reported performance was "31 out of 32 pass".
  • For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability Class), the specific number of samples tested is not explicitly stated, but the results are reported as single values (percentages, pressure, or class), implying multiple samples were likely tested to obtain representative values for product conformance.
• Data Provenance: Not explicitly stated regarding the origin of the testing data itself (e.g., country of origin of the samples). However, the manufacturer is in Heilongjiang, China. The tests were performed in accordance with ASTM and MIL standards, which are international standards. The study is a non-clinical test to demonstrate device performance against established standards. It is analogous to a prospective study in the sense that the device was manufactured and then tested to these specific criteria.

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

• Not Applicable. This is a physical medical device (surgical mask), not an AI/ML diagnostic or predictive device. "Ground truth" in this context refers to the measured physical characteristics (e.g., filtration efficiency, fluid resistance) as determined by standardized laboratory testing methods, not by expert interpretation of images or patient data. The expertise lies in performing and interpreting these specific laboratory tests according to the cited ASTM and MIL standards.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there is no expert adjudication for the objective physical and biological performance tests of a surgical mask. Results are based on quantitative measurements.

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

• No. This type of study is relevant for AI/ML devices where human readers (e.g., radiologists) use the AI to improve their performance. This 510(k) is for a physical surgical mask and does not involve AI assistance for human readers.

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

• Not Applicable. There is no algorithm or AI component to this medical device.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on objective, standardized laboratory measurements of its physical properties (e.g., fluid resistance, filtration efficiency, differential pressure, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). These are determined by adhering to specified test methods from organizations like ASTM and MIL.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on design specifications and then tested to verify its performance.

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

• Not Applicable. As per point 8, there is no training set.

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The Disposable 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.

Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose. There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.

The provided document is a 510(k) summary for a Disposable Surgical Mask (K210042). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the context of an AI/ML medical device. The document details performance testing for physical and material properties of the surgical masks.

Therefore, most of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission.

However, I can extract the relevant acceptance criteria and performance data for the Disposable Surgical Mask as presented in the document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Performance):

This table is directly from the "IX. PERFORMANCE DATA" section of the document. The acceptance criteria and results refer to the physical and barrier performance of the surgical mask material.

Study that Proves the Device Meets Acceptance Criteria (as described for this non-AI/ML device):

The document states: "Non-clinical tests were conducted to verify that the proposed device met all design specifications found in the test methodology and standard using 3 nonconsecutive lots." The "Test Methodology" column in the table above lists the specific ASTM, EN, MIL-M, and ISO standards used for each test. The "Results" column confirms that the device passed all specified acceptance criteria for these physical and biological tests.

Regarding AI/ML specific questions (which are NOT applicable to this document):

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "sample size" is the number of mask samples tested (e.g., "32/32 Passed"). Data provenance would be from laboratory testing results based on specific mask lots.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-AI/ML medical devices like surgical masks is established via objective physical and biological tests against established industry standards.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 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: For this device, the "ground truth" is defined by compliance with the specified performance standards (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, 16 CFR Part 1610 for Flammability, ISO 10993-X for biocompatibility).
• 8. The sample size for the training set: Not applicable. No AI/ML model for training.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a traditional medical device (surgical mask) and describes its physical and biological performance testing, not the performance of an AI/ML algorithm.

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The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.

The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.

The provided text describes the performance data and acceptance criteria for a Disposable Surgical Mask (Model: YYKZ-01) in a 510(k) summary. 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

The document does not explicitly state the sample sizes for each specific test within the performance and biocompatibility sections. However, it indicates standard test methods were used (e.g., ASTM F2101-19 for BFE, ASTM F2299-03(2017) for PFE, ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2010 for Sensitization and Irritation). These methods typically specify minimum sample sizes for reliable results.

The data provenance is retrospective, as the tests were conducted on the device to demonstrate equivalence to a predicate device for marketing approval. The source of the data is implied to be from testing facilities in China, as the submitter, Jiaxing Amazing Travel-Ware CO., LTD, is located in Jiaxing, Zhejiang, China.

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

This information is not provided in the document. The "ground truth" for these tests comes directly from the established technical standards and the objective measurements performed in a laboratory setting, rather than expert interpretation of medical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involves objective laboratory testing against defined criteria, not subjective interpretation requiring adjudication.

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 is not applicable. The device is a physical product (Disposable Surgical Mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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 product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (BFE, PFE, Differential Pressure, Synthetic Blood Penetration, Flammability) is based on objective measurements against established industry standards and specifications (ASTM F2100-19 Level 1 criteria).

For biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation), the ground truth is established through biological assays using established protocols (ISO 10993-5 and ISO 10993-10) with clearly defined pass/fail criteria based on observed biological responses (e.g., cell viability, skin reactions).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

Ask a specific question about this device

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

The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask 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 cloth. The model of proposed device, ear loops, 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 Elastic materials consisting of Nylon low elastic yarn and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene and galvanized iron wire plastic materials. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The document describes the non-clinical performance testing of a disposable surgical mask to demonstrate its substantial equivalence to a predicate device, rather than a study involving an AI-powered device or human readers. Therefore, much of the requested information regarding AI assistance, human readers, effect size, and ground truth establishment for AI models is not applicable to this document.

However, I can provide information based on the performance testing of the surgical mask.

1. A 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): 32 samples per lot, tested across three lots (though the table summarizes the results for the current device as "31 out of 32 Pass at 120 mmHg" without specifying if this is across multiple lots for the current device). For the predicate, it states "32 out of 32 pass at 120 mmHg".
• Other performance tests (PFE, BFE, Differential Pressure, Flammability): The exact sample size for these specific tests is not explicitly stated as a number of individual masks, but rather a percentage or single value representing the performance of the device. These are typically performed on a representative sample of the manufactured product.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not explicitly stated, but typically involves a defined number of samples according to ISO standards.
• Data Provenance: The tests were conducted internally by SHANGHAI NO.9 KNITTING MILL CO., LTD., likely in a laboratory setting. The document does not specify the country of origin of the test samples beyond the manufacturing location (Shanghai, China). These are prospective tests on the manufactured product to demonstrate compliance.

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

This question is not applicable. The "ground truth" here refers to established technical standards (like ASTM, ISO, EN, CFR) for material and product performance, not expert consensus on interpretations of data. The results are objective measurements against these predefined numerical and qualitative criteria.

4. Adjudication method for the test set

This question is not applicable. The test results are objective measurements (e.g., percentages, pressure readings, "pass/fail" based on established criteria) and do not involve human interpretation 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 is not an AI device. No MRMC study was performed.

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

This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria are derived directly from these technical specifications for medical face masks, specifically for Level 2 performance.

8. The sample size for the training set

This is not an AI device. There is no concept of a "training set" in this context.

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

This is not an AI device. There is no concept of a "training set" or "ground truth establishment for a training set." The "ground truth" for the acceptance criteria for the surgical mask is established by widely recognized and published national and international standards for medical device performance.

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

The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes a 510(k) premarket notification for a Disposable Surgical Mask (non-sterile), K211451, submitted by Qinhuangdao Taizhi Medical Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182515, Surgical Face Mask by Wuhan Dymex Healthcare Co., Ltd.) through non-clinical testing.

Based on the provided text, the device in question is a Disposable Surgical Mask, not an AI or imaging device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, expert qualification, adjudication method, MRMC study, standalone performance, type of ground truth) typically associated with the development and validation of AI/ML-based medical devices or diagnostic tools are not applicable.

The acceptance criteria and study proving the device meets them are related to the physical and performance characteristics of a surgical mask, as per established standards and guidance for such products.

Here's the information extracted from the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for Disposable Surgical Mask (K211451)

The device demonstrates conformance to recognized standards and requirements for surgical face masks through non-clinical performance and biocompatibility testing. The testing was conducted to establish substantial equivalence to a predicate device (K182515).

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes the performance testing results against established acceptance criteria for surgical masks (specifically, Level 2, ASTM F2100-19):

Biocompatibility Testing:

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

• Sample Size: The exact sample size for each specific non-clinical test (e.g., number of masks tested for BFE, PFE, etc.) is not explicitly stated, beyond "32 of 32 test articles" for synthetic blood penetration. However, the testing was conducted according to recognized standards (e.g., ASTM F2100-19), which would prescribe appropriate sample sizes for each test.
• Data Provenance: The origin of the data is from required non-clinical performance and biocompatibility testing performed on the manufactured device. The location of the test facility is not specified beyond the manufacturer's location in China. This is prospective testing conducted specifically for regulatory submission.

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

• This is not applicable for a surgical mask. "Ground truth" in this context refers to objective scientific measurements and conformance to standardized performance criteria, not expert consensus on diagnostic interpretations. The tests themselves are the "ground truth." These tests are performed by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

• Not applicable. Performance metrics are objectively measured against pre-defined thresholds.

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

• Not applicable. This device is a surgical mask, not an AI or diagnostic tool requiring human reader studies.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on objective measurements obtained through standardized laboratory testing for physical and performance characteristics (e.g., filtration efficiency, differential pressure, fluid resistance, flame spread) and biocompatibility, as defined by recognized standards like ASTM F2100-19.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML product developed using training datasets.

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

• Not applicable.

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The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. 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 provided non-sterile.

Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.

The provided document is a 510(k) premarket notification for a Disposable Surgical Mask (K210267). It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Surgical Mask, K210267) is a surgical mask intended to meet Level 2 performance according to ASTM F2100:2019. The acceptance criteria and the device's reported performance are summarized in the table below:

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

• Sample Size for Performance Tests: For performance tests like Synthetic Blood Penetration, Flammability, Differential Pressure, Bacterial Filtration Efficiency, and Latex Particle Challenge, a sample size of 32/32 was used as indicated by "32/32 Passed" in the results.
• Sample Size for Biocompatibility Tests: The document doesn't explicitly state the exact sample size (number of devices or extracts) used for the biocompatibility tests (Cytotoxicity, Irritation, Sensitization). It only states "Under the conditions of the study, the subject device extract was determined to be..."
• Data Provenance: The tests were conducted in a lab ("Samples submitted to the testing lab"). The document does not specify the country of origin of the lab or if the data is retrospective or prospective, beyond saying the tests were conducted to verify the proposed device met design specifications. These are non-clinical (laboratory) studies, not human subject studies.

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

• This information is not applicable for this submission. The "ground truth" for the performance tests of a surgical mask is established by validated standardized test methods (e.g., ASTM, EN, ISO standards) and their predefined pass/fail criteria, not by expert consensus on clinical findings. Biocompatibility assessment is also based on established in-vitro and in-vivo biological evaluation standards.

4. Adjudication Method for the Test Set

• This is not applicable. As the evaluation involved standardized performance and biocompatibility laboratory tests, there was no need for an adjudication method by human experts. The results are quantitative and compared against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• This is not applicable. This is a 510(k) submission for a physical medical device (Disposable Surgical Mask), not an AI/software device. No MRMC comparative effectiveness study was performed or required.

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

• This is not applicable. This is a physical medical device; there is no algorithm or human-in-the-loop component.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is based on standardized test methods and their defined pass/fail criteria. For example:
  • Performance: Measured values (e.g., pressure, filtration efficiency, burn time) are compared against the numerical criteria specified in ASTM F2100 Level 2, 16 CFR Part 1610, and EN 14683.
  • Biocompatibility: Biological responses (e.g., cell viability, skin reactions) are assessed against the criteria for "non-cytotoxic," "non-irritating," and "non-sensitizing" as outlined in ISO 10993 standards.

8. The Sample Size for the Training Set

• This is not applicable. Since no AI or machine learning model is involved, there is no "training set."

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

• This is not applicable. As there is no training set.

Ask a specific question about this device

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

The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The mask is composed of 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 nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.

The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

The document describes the non-clinical testing performed to demonstrate that the Disposable Surgical Mask (Model MP9017) manufactured by XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD meets its acceptance criteria and is substantially equivalent 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

The document does not explicitly state the sample sizes for each test in the acceptance criteria table (Table 2 and 3). However:

• Fluid Resistance (ASTM F1862): The acceptance criteria and performance indicate a sample size of 32 test articles.
• Other performance tests (PFE, BFE, Differential Pressure, Flammability): The specific sample sizes for these tests are not provided.
• Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes are not provided, but these tests are typically conducted in vitro or on animal models following ISO 10993 guidelines.

Data Provenance: The non-clinical tests were conducted by the manufacturer, XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD, based in China (Xiamen, Fujian). The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, these would typically be newly conducted prospective tests.

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 acceptance criteria are based on established international standards (ASTM, EN, ISO, CFR) for medical device performance and biocompatibility, not on expert consensus for a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective laboratory measurements against defined standards, not subjective assessments requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." Surgical masks are typically evaluated through non-clinical performance and biocompatibility testing against established standards, not through studies involving human readers or comparative effectiveness with AI.

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

No, a standalone algorithm performance study was not done. This device is a physical product (surgical mask), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test results is based on objective measurements performed according to established international standards and test methods. For example:

• Fluid Resistance: Measured according to ASTM F1862.
• Filtration Efficiency: Measured according to ASTM F2299 (PFE) and ASTM F2101 (BFE).
• Differential Pressure: Measured according to EN 14683 Annex C.
• Flammability: Measured according to 16 CFR 1610.
• Biocompatibility: Evaluated according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical surgical mask and does not involve an AI algorithm that requires a training set. The term "training set" is relevant for AI/machine learning models.

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

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

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The Disposable 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 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 proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) 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 model of proposed device, ear loops, 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 and polyester fiber. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The document describes the acceptance criteria and performance of the Disposable Surgical Mask device by Safeway Industry Healthcare.

Here's the breakdown of the information requested:

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

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

• Fluid Resistance (ASTM F1862): 32 samples per test condition for each of the 3 non-consecutive lots (96 samples total for this test). The data provenance is not explicitly stated as country of origin, but the submission is from Safeway Industry Healthcare in Hubei, China, implying the tests were conducted there or commissioned by them. The study is retrospective as these are test results from manufactured lots.
• Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta P) (EN 14683 Annex C), Flammability (16 CFR 1610): The results are reported for 3 non-consecutive lots (Lot1, Lot2, Lot3). The specific number of masks tested within each lot for these performance characteristics is not explicitly stated, but the results are given as a single value per lot for efficiency/pressure. The data provenance is implied to be from China and the studies are retrospective.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): The sample size for these tests is not explicitly stated but "the device" is referenced, meaning the materials of the device were tested. The data provenance is implied to be from China and the studies are retrospective.

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 (N/A) because the device is a Disposable Surgical Mask, and its performance is evaluated through standardized laboratory-based material science tests (e.g., filtration efficiency, fluid resistance) and biocompatibility tests. There is no human interpretative "ground truth" established by experts in the context of this device's performance evaluation.

4. Adjudication method for the test set:

This information is N/A for the same reasons as #3. The tests are objective quantitative measurements, not subjective evaluations 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. The device is a surgical mask, not an AI software or system designed for interpretation by human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

This information is N/A. The device is a physical product (surgical mask), not an algorithm.

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

The "ground truth" for the performance evaluation of the surgical mask is based on objective, standardized laboratory test results against predefined regulatory and industry standards (e.g., ASTM F2100, ASTM F1862, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this type of device.

8. The sample size for the training set:

This information is N/A. The device described is a physical product (surgical mask), not a machine learning model that requires a training set.

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

This information is N/A for the same reason as #8.

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When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.

The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.

This document pertains to the 510(k) premarket notification for a Disposable Surgical Mask (K203756). The study described focuses on the device's functional performance and biocompatibility rather than human-in-the-loop performance with an AI. Therefore, the questions related to AI assistance, human reader improvement, multi-reader multi-case studies, and ground truth establishment from expert consensus for AI training are not applicable to the context of this traditional medical device submission.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the device's performance evaluation is found in the "Summary of Non-clinical Testing" section, specifically in the table on page 8.

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

For the performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), results are reported for 3 lots of the disposable surgical mask. Specific sample sizes within each lot for individual tests are provided where applicable (e.g., 32 out of 32 for Fluid Resistance).

The data provenance is from non-clinical testing, likely conducted by the manufacturer or a contracted lab in China, given the manufacturer's location (Yixing, Jiangsu, China). The data is by nature prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with performance and biocompatibility standards.

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

Not applicable. This submission is for a traditional medical device (surgical mask), not an AI device requiring ground truth established by expert medical reviewers. The "ground truth" for the device's performance is established by standardized, objective laboratory test methods (e.g., ASTM, EN, ISO standards), which measure physical and biological properties.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective laboratory measurements according to established standards, there is no need for expert adjudication.

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

No. This is a submission for a physical medical device (surgical mask), not an AI-assisted diagnostic or treatment system. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to this submission.

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

Not applicable. This submission is for a non-AI physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is based on objective, quantitative measurements performed according to recognized international and national standards. This includes:

• Physical Performance Data: Measured values for fluid resistance, particulate filtration efficiency, bacterial filtration efficiency, differential pressure, and flammability.
• Biocompatibility Data: Results from in vitro cytotoxicity tests and in vivo irritation and sensitization tests (using animal models, specifically rabbits and guinea pigs).

These standards define the acceptable range or threshold for each performance characteristic, effectively serving as the "ground truth" for the device's safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The device's performance is based on its physical design and materials, which are verified through the non-clinical tests described.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this submission.

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