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The Disposable Medical Face 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 Medical Face 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 Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.

Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (M643BE). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, 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:

• Sample Size: For performance testing (BFE, Differential Pressure, Particulate Filtration, Synthetic Blood Resistance, Flammability), the sample size used was 32 units per lot for 3 non-consecutive lots.
• Data Provenance: The document does not explicitly state the country of origin where the tests were performed or if the data was retrospective or prospective. Given that the applicant is in Taiwan and the submission correspondent is in China, the testing likely occurred in one of these regions. The testing described is prospective (i.e., new tests conducted specifically for this submission).

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

This submission does not involve a clinical study or human interpretation of data for the ground truth. The "ground truth" for the performance testing is established by the specified ASTM, EN, and CFR standards' methodologies and acceptance criteria. The qualifications of the personnel performing these standardized laboratory tests are not detailed but are assumed to meet the requirements of the testing laboratories.

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

Not applicable. This is not a study involving human readers or subjective interpretation that would require adjudication. The tests are objective, laboratory-based performance measurements against defined standards.

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 document pertains to a physical medical device (face mask), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed.

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

Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the physical properties of the mask tested in a laboratory setting.

7. The type of ground truth used:

The ground truth for this device's performance is based on established industry standards and regulatory requirements (ASTM, EN, CFR, ISO standards). These standards define the test methods and the acceptable performance thresholds for medical face masks.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model; therefore, there is no "training set."

9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical medical device.

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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.

The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided FDA 510(k) summary describes the acceptance criteria and the study results for the Disposable Surgical Face Mask (M663BE, M663BT).

Here's a breakdown of the 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

• Fluid Resistance Test:
  • Sample size: 32 samples per lot, tested across 3 lots. (Total 96 masks).
  • Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.
• Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility (Cytotoxicity, Irritation, Sensitization):
  • The specific number of samples for each of these tests is not individually detailed in the provided summary, beyond the "3 lots" mention for fluid resistance which might imply similar lot-based testing for other performance characteristics. The results are typically reported as averages across tests.
  • Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.

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 device is a Disposable Surgical Face Mask, and the performance evaluation relies on standardized non-clinical laboratory tests rather than expert interpretation of medical images or patient data.

4. Adjudication method for the test set

This information is not applicable as the performance evaluation relies on standardized non-clinical laboratory tests with objective pass/fail criteria, not on human interpretation or adjudication processes.

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 not applicable. The device is a surgical face mask, and the evaluation does not involve AI or human readers for diagnostic purposes.

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 face mask, and its performance evaluation does not involve an algorithm.

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

The "ground truth" for the device's performance is established by reference to established industrial standards and test methods. For example:

• Fluid Resistance: ASTM F1862 and ASTM F2100 Level 3.
• Particulate Filtration Efficiency: ASTM F2299.
• Bacterial Filtration Efficiency: ASTM F2101.
• Differential Pressure: EN 14683 Annex C.
• Flammability: 16 CFR 1610.
• Biocompatibility: ISO 10993 (Parts 5 and 10).

8. The sample size for the training set

This information is not applicable. The device is a surgical face mask and its development and evaluation do not involve machine learning models that require a training set.

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

This information is not applicable for the reasons stated in point 8.

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The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. This device also meets CDC Guidelines for TB Exposure Control.

The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.

Here's a breakdown of the acceptance criteria and study information for the Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document emphasizes substantial equivalence to a predicate device (Gerson Isolair APR Type N95 Mask Model 2735, K960778) as the primary proof of safety and effectiveness, meaning the new device performs comparably to an already approved device.

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

• Sample Size: Not explicitly stated. The document refers to "the use of 0.3 micron diameter challenge" for filtration efficiency testing, and tests performed by NIOSH and Nelson Laboratories. It does not specify the number of masks or trials involved in these tests.
• Data Provenance: The tests were conducted by recognized testing laboratories: NIOSH (National Institute for Occupational Safety and Health) and Nelson Laboratories. The data is prospective, as it involves active testing of the Makrite device. The country of origin for these testing bodies is the United States.

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

Not applicable. This device is a physical product, and its performance is assessed through objective, standardized laboratory tests, not subjective expert evaluation of data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or medical diagnosis. The "ground truth" is defined by the objective measurement standards of the relevant test protocols (e.g., 95% filtration efficiency for N95).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation relies on objective laboratory test results, not expert consensus or adjudication of subjective interpretations.

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 diagnostic devices that involve human interpretation of images or other data, where the goal is to evaluate the impact of a new tool (like AI) on physician performance. The Makrite Model 910-N95 is a physical protective device, not a diagnostic tool requiring human interpretation.

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

Yes, in a sense, the performance of the device itself (the "algorithm" in this analogy) was tested in a standalone manner. The tests reported (filtration efficiency, breathing resistance, synthetic blood penetration, irritation) are all direct measurements of the mask's physical properties and performance without human interaction beyond conducting the test.

7. The Type of Ground Truth Used

The ground truth used is based on objective, standardized test criteria and regulatory requirements. For example:

• NIOSH N95 certification: The ground truth is defined by the NIOSH 42 CFR 84 standard, which specifies 95% efficiency against 0.3 micron particles.
• Synthetic Blood Penetration: The ground truth is defined by the ASTMF1862-00 standard for resistance.
• Breathing Resistance: The ground truth is defined by NIOSH 30 CFR11 section 11.140-9.

These are established benchmarks for performance, not subjective expert opinions or clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. The Makrite Model 910-N95 is a manufactured product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Its performance is inherent in its design and manufacturing materials, verified through 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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