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

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.

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

Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:

Table 1: Acceptance Criteria and Reported Device Performance

Study Details (Applicable to Face Mask Device)

Given that the device is a medical face mask, the "study" primarily consists of non-clinical, laboratory-based performance and biocompatibility testing, not clinical trials or AI performance evaluations as would be done for software.

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

   • Sample Size: Not explicitly stated in terms of number of masks or test replicates for each test, but standard test methodologies (e.g., ASTM F1862/F1862M-24, ASTM F2101-23) typically specify a minimum number of samples. The results are given for specific "lots" (e.g., Yellow mask (Level 1), White mask (Level 1), Blue mask (Level 1, 2, 3)), implying that multiple samples from these production lots were tested.
   • Data Provenance: Not explicitly stated. The manufacturer is Winner Medical Co., Ltd. from Shenzhen, China. This indicates the testing was likely conducted in China or by labs accredited to perform these standards. The tests are "Non clinical tests," meaning they are laboratory experiments rather than human subject or retrospective studies.

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

   • Not Applicable. For this type of device (medical mask), "ground truth" is established by adherence to validated, objective, and standardized laboratory test methodologies and measurements, not by expert human interpretation (like in imaging for AI). The tests measure physical and biological properties directly.

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

   • Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., reading medical images) where there can be inter-reader variability. These are objective, quantitative laboratory tests.

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

   • Not Applicable. This is a physical medical device (mask), not an AI-powered diagnostic tool. MRMC studies are used to assess the performance of AI systems in combination with human readers.

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

   • Not Applicable. This is a physical medical device (mask), not an algorithm.

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

   • Objective Laboratory Measurements/Standards. The "ground truth" for this device is based on the objective measurements obtained through the specified ASTM, EN, CFR, and ISO standards (e.g., bacterial filtration efficiency percentage, differential pressure values, absence of penetration by synthetic blood, flammability class, cellular toxicity grading, sensitization response). These are empirical, quantitative, and qualitative results from standardized test protocols.

7. The sample size for the training set:

   • Not Applicable. This is a physical device being tested against performance standards, not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As above, no training set for an algorithm is involved.

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The Procedure mask/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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

This document is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). The information provided demonstrates that the device meets the acceptance criteria through non-clinical testing.

Here's the breakdown of your requested information:

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)

The document does not explicitly state the specific sample sizes for each non-clinical test. However, it indicates that the tests were performed in accordance with the referenced standards (e.g., ASTM F1862/F1862M, ASTM F2299/F2299M-03, ASTM F2101, EN 14683, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards typically define appropriate sample sizes for such tests.

The provenance of the data is that the tests were performed on the proposed device by Winner Medical Co., Ltd. The company is located in Shenzhen, Guangdong, China. The data is prospective, generated specifically for this 510(k) submission.

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

This is a non-clinical study for a physical device (surgical mask) based on standardized test methods for material performance and biocompatibility. Therefore, the "ground truth" is defined by the established acceptance criteria within those standards, as measured by laboratory testing. There are no "experts" in the sense of medical professionals establishing ground truth from observational data; rather, the expertise lies in the certified laboratories and personnel performing the standardized tests.

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

This is not applicable for non-clinical performance testing of a physical device. The results are obtained through standardized laboratory measurements.

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

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The ground truth for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (ASTM, EN, ISO, CFR) for medical face masks and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. As noted above, there is no training set for this device.

Ask a specific question about this device

The Procedure mask/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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.

Therefore, I cannot extract information related to:

• Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
• Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
• Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
• Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
• Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify general "sample sizes" in terms of number of patient cases or images, as this is a physical product's performance validation. The "tests" refer to laboratory evaluations of material properties. The provenance of the testing data is not explicitly stated beyond being "non-clinical tests" conducted to verify compliance with standards. It does not indicate country of origin for test data or whether tests were retrospective or prospective, as these are material property tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device (a face mask) is established by adherence to recognized international and national standards (e.g., ASTM, EN, ISO, CFR) for material performance, not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for physical medical devices like face masks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the results of standardized physical and biological tests, which measure specific material properties and performance characteristics against predefined thresholds in the cited standards (e.g., ASTM F1862/F1862M for synthetic blood penetration, ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility).

8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model.

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