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

The Medical Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.

The model of proposed device, Ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The nose clamp contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of metal core plastic.

The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.

The provided text is a 510(k) summary for a Medical Mask (K210020). It describes the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically focusing on non-clinical performance standards for medical face masks.

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

Acceptance Criteria and Device Performance

The acceptance criteria for this medical mask are based on established performance standards for surgical masks, primarily ASTM F2100-19 (Standard Specification For Performance of Materials used in Medical Face Masks) for Level 3 categorization, and other supporting standards for specific properties.

Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states "Level 3" under the "Comparison item" table, implying the performance results are a demonstration of meeting Level 3 requirements as per ASTM F2100-19.

Study Details:

This submission is for a medical device (Medical Mask), and the "study" refers to the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. It's not a clinical study in the typical sense of evaluating patient outcomes or diagnostic accuracy.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many masks were tested for BFE, PFE, etc.). These numbers would typically be found in the detailed test reports submitted to the FDA, but they are not included in this 510(k) summary.
   • Data Provenance: The testing was conducted as part of a 510(k) submission from Zhende Medical Co., Ltd. in China. The regulatory standards (ASTM, EN, ISO, CFR) are international/US standards. The data is retrospective in the sense that it was collected prior to the 510(k) submission, specifically for the purpose of demonstrating substantial equivalence.

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

   • This is not applicable in the context of this device and testing. For medical masks, "ground truth" is established by the specified performance standards (e.g., a BFE of >98% is the ground truth for BFE at Level 3). The tests themselves are the means of establishing whether the mask meets these pre-defined physical and biological performance characteristics. There isn't a team of human "experts" establishing a "ground truth" through consensus in the way there would be for, say, medical imaging interpretation. The experts involved would be laboratory technicians and engineers performing validated tests according to the standards.

3. Adjudication Method for the Test Set:

   • Not applicable. Performance testing of physical products against defined standards does not involve an adjudication method in the same way clinical trials or image readings might. The results are quantitative measurements or pass/fail determinations based on predefined criteria.

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

   • No, an MRMC study was not done. The document explicitly states: "No clinical tests were performed." MRMC studies are typically used for diagnostic devices involving human interpretation of medical data (e.g., radiology AI tools). This device is a medical mask, which is evaluated based on its physical and biological barrier properties.

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

   • This question is slightly misapplied to a medical mask. If interpreted as "was the device's performance evaluated independently of human use for its intended function (e.g., filtration efficiency tested on a machine)?" then yes. The performance metrics like BFE, PFE, fluid resistance, flammability, differential pressure, and biocompatibility are all measured in a standalone laboratory setting, independent of human interaction during the test itself. The mask's performance is the algorithm in this context – its material composition and design dictate its performance.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is based on pre-defined, internationally recognized technical standards and specifications. These standards (e.g., ASTM F2100-19 for medical face masks) lay out the specific performance thresholds (e.g., >98% BFE, >98% PFE, <6.0 mm H2O/cm² differential pressure) that a mask must meet to be classified at a certain level (in this case, Level 3). Biocompatibility is also assessed against ISO standards.

7. The Sample Size for the Training Set:

   • This question is not applicable. The Medical Mask is a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The "training" in this analogy would be the manufacturing process and quality controls that result in a consistent product.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for a physical device like a medical mask. The concept of ground truth in this context relates to the established performance requirements of the relevant standards.

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

The Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Medical 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 not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical Masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the acceptance criteria and the study conducted for the Medical Mask (Model L1171801) by Zhende Medical Co., Ltd. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance Performance (ASTM F1862): 3 non-consecutive lots were tested. For each lot, 32 samples were tested. Thus, the total sample size for fluid resistance testing was $3 \times 32 = 96$ masks.
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes for these tests are not explicitly stated in the provided text, beyond the acceptance criteria for fluid resistance.
• Data Provenance: Not explicitly stated whether the data is from the country of origin (China) or elsewhere. The study appears to be a manufacturer-conducted non-clinical study to demonstrate compliance with international standards. The study is retrospective in the sense that it's a pre-market submission, testing the final manufactured device according to established protocols.

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 as the study is a non-clinical performance evaluation of a physical medical device (Medical Mask) rather than an AI/software device requiring expert interpretation of results. The "ground truth" for the test set is defined by the objective measurement standards outlined in the industrial specifications (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993).

4. Adjudication method for the test set:

This is not applicable since the study involves objective physical and biological performance tests, not human interpretation or adjudication of complex data. The acceptance criteria define the pass/fail for each test.

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 Medical Mask, not an AI/software device that would involve human readers or AI assistance for medical image interpretation or diagnosis.

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 Medical Mask.

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

The "ground truth" for this device's performance evaluation is based on objective, standardized test methods and their defined limits (e.g., minimum filtration efficiency, maximum pressure differential, pass/fail for cytotoxicity). These standards are well-established in the medical device industry for surgical masks.

8. The sample size for the training set:

This is not applicable as the Medical Mask is a physical device, not an AI/machine learning model that requires a training set. The manufacturing process is designed and validated, not "trained" in the AI sense.

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

This is not applicable for the reasons stated above.

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