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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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.

This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance and biocompatibility testing program, as detailed in Table 3 of the submission. The key objective was to demonstrate that the subject device performs "as well as or better than the identified predicate device" (K160269) across all specified test parameters, and specifically that the change in nose clamp material (from polyethylene coated steel wire to just polyethylene) does not negatively impact performance, and allows for MR safety.

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

The document does not explicitly state the specific sample sizes (number of masks tested) for each of the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). However, it implies that the tests were conducted according to the relevant ASTM and ISO standards, which typically specify sample sizes for such evaluations.

• Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer (SAN-M PACKAGE CO., LTD.) being located in Japan. The type of study is prospective non-clinical performance and biocompatibility testing conducted on the newly manufactured subject device and, for comparison, on the predicate device.

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

This information is not applicable in this context. The "ground truth" for a medical mask's performance is established by adherence to recognized performance standards (e.g., ASTM F2100-11, ISO 10993) and measured through objective laboratory tests. There is no concept of expert consensus or interpretation for these physical and biological performance characteristics.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where human reviewers make subjective assessments that might require a consensus. Performance tests for surgical masks are objective, standardized laboratory measurements that yield quantitative results (e.g., filtration efficiency percentages, pressure differentials, pass/fail for chemical tests).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging devices where multiple readers interpret cases to assess the effectiveness of an AI system, with and without AI assistance. The device in question is a surgical face mask, which does not involve human interpretation or AI assistance in its function or evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. This concept applies to AI/ML software as a medical device (SaMD). The device under review is a physical medical device (surgical face mask), not an algorithm or software. Its performance is evaluated through direct physical and biological testing.

7. Type of Ground Truth Used

The "ground truth" for the performance of the surgical face masks is established through objective, standardized laboratory measurements against predefined thresholds and criteria outlined in recognized national and international standards (e.g., ASTM F2100-11 for mask performance, ISO 10993 for biocompatibility, 16 CFR 1610 for flammability, MIL-M-36945C for differential pressure). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather on physical and chemical properties and biological response.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical face 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 for the same reason as point 8.

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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 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 nonsterile.

The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.

Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance

Note: For ASTM F2299 and ASTM F2101, the document reports "Pass at" a certain percentage. The acceptance criteria for these would typically be a minimum percentage, which the reported values exceed.
Note: For Differential Pressure, the acceptance criteria are maximum values (e.g., <5.0 mmH2O/cm²), and the device's reported values fall within these limits.

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

The document does not explicitly state the sample sizes for the individual performance tests (e.g., how many masks were tested for fluid resistance). The nature of these tests (e.g., ASTM F1862, F2299, F2101) typically involves standardized replicates as specified by the respective standards.

The data provenance is from non-clinical tests conducted on the proposed device. The country of origin of the data is not specified, but the applicant is from Japan (SAN-M PACKAGE CO., LTD.) and the US Correspondent is Globizz Corporation. The tests are "non-clinical tests" as opposed to human studies, so the retrospective or prospective nature in the clinical sense is not directly applicable. These are laboratory-based performance tests usually conducted in a controlled environment.

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 to this type of device and study. The "ground truth" for these tests are the established performance requirements of the referenced ASTM and ISO standards, which are objective, quantifiable measurements (e.g., pass/fail for fluid penetration, percentage filtration, pressure drop). These are not subjective interpretations requiring expert consensus.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving subjective assessments by human readers/experts to resolve discrepancies. The performance tests for surgical masks are objective laboratory measurements against predefined 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

This is not applicable. The device is a surgical face mask, not an AI-powered diagnostic device. No MRMC study was conducted.

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 physical product (surgical face mask), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for these tests are the established performance requirements defined by recognized international and national standards:

• ASTM F2100-11: Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulate Matter Using a Latex Sphere Aerosol
• ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• MIL-M36945C: General Performance Requirements for Filtering Facepiece Respirators (likely referenced for differential pressure, though the specific ASTM equivalent is often used now)
• 16 CFR 1610: Standard for the Flammability of Clothing Textiles
• ISO 10993 (specifically ISO 10993-5 and ISO 10993-10): Biological evaluation of medical devices for cytotoxicity, irritation, and sensitization.

These standards provide objective, measurable criteria, not expert consensus or pathology on individual cases.

8. The sample size for the training set

This is not applicable. This is a physical product, not a machine learning model, so 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."

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The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.

The provided document describes the acceptance criteria and performance of the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, in comparison to a predicate device.

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 (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of masks tested for fluid resistance or flammability). It simply states that the models meet the requirements of the standards. The provenance of the data is not specified beyond indicating it was a submission to the FDA. The tests are described as performance testing and non-clinical tests, which are typically prospective.

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 information is not applicable to the type of device and testing described. The "ground truth" for N95 masks is established through standardized laboratory performance tests according to recognized standards (e.g., ASTM, NIOSH, ISO) and not through expert consensus or interpretation of medical images.

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

This information is not applicable. Adjudication methods like 2+1 are typically used in studies where human readers interpret medical data (e.g., radiology studies) and their findings need to be reconciled. For performance testing of a physical device like an N95 mask, objective laboratory measurements are taken against predefined criteria.

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 physical N95 mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this document.

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 physical N95 mask; there is no algorithm or AI component involved. The testing described is for the physical performance of the mask.

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

The ground truth for the performance of the N95 mask is based on objective measurements against established performance standards set by regulatory bodies and testing organizations. These include:

• ASTM F1862 for Fluid Resistance
• NIOSH Certification (TC 84A-3348) for Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure
• 16 CFR 1610 for Flammability
• ISO 10993 series for Biocompatibility (cytotoxicity, irritation, sensitization)

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of performance testing for a physical medical device like an N95 mask. Training sets are relevant for machine learning or AI models.

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

This information is not applicable, as there is no training set for this type of device and study.

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