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Surgical Face Mask 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 Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.

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 model of proposed device, ear loops, 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 ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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 the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE). However, for Resistance to penetration by synthetic blood and Flame spread, it states that 32 test articles were used.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given this is a 510(k) submission for a Chinese manufacturer (Xiantao Daoqi Plastic Co., Ltd.) and tests are cited against international (ISO) and US (ASTM) standards, the testing was likely conducted in laboratories, possibly in China or other accredited facilities. The nature of these tests (bench testing) implies they are prospective assessments of product samples.

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 to this type of submission. The ground truth for these medical device tests (surgical face mask performance and biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO). These standards define specific methodologies and acceptance criteria. No human experts are involved in establishing "ground truth" in the way they would for a diagnostic AI study. The "experts" are the technicians performing the standardized tests and interpreting the results against the defined criteria.

4. Adjudication method for the test set

This information is not applicable. The tests are objective measurements against predefined criteria in recognized standards. There is no adjudication process involving multiple human observers or adjudicators for these types of physical and chemical tests.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems, not for a physical device like a surgical face mask.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The device is a physical surgical face mask.

7. The type of ground truth used

The "ground truth" for this device is established by objective measurements and assessments against recognized performance and biocompatibility standards (ASTM F2100-23, ASTM F2101-23, ASTM F1862/F1862M-17, ISO 10993-5, ISO 10993-23, ISO 10993-10). These standards define the acceptable range of physical properties and biological responses for surgical masks.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set.

Ask a specific question about this device

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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

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

The body of the face 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.

The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The document is a 510(k) premarket notification for a Surgical Face Mask. It primarily focuses on the device's substantial equivalence to a predicate device, supported by non-clinical performance testing and biocompatibility assessments. It explicitly states that no clinical studies were performed. As such, the information provided does not pertain to the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human-in-the-loop diagnostic device as implied by the detailed questions.

Therefore, many of the requested details, such as those related to AI performance, human reader improvement, ground truth establishment for training and test sets, expert consensus, and multi-reader multi-case studies, are not applicable to this document.

However, I can extract the acceptance criteria and the device performance for the non-clinical tests conducted for this surgical face mask.

Here's the information based on the provided document, addressing the extractable points and noting the non-applicability of others:

Device: Surgical Face Mask (Kingstar Medical (Xianning) Co., Ltd.)
Predicate Device: K210433 Surgical Face Mask (Wuhan Dymex Healthcare Co., Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)

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

• Sample Size for Test Set:
  • Fluid Resistance: "32 out of 32 pass" indicates at least 32 samples were tested across 3 lots.
  • For other functional tests (PFE, BFE, Differential Pressure, Flammability) and biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the specific number of masks or test replicates is not explicitly stated, beyond the qualitative "Pass" or "minimum/maximum" values. However, the tests are done according to recognized standards (ASTM, EN, ISO) which would prescribe sample sizes.
• Data Provenance: The tests were non-clinical, conducted to verify compliance with standards. The origin of the raw materials is China (Xianning City, Hubei Province), and the testing facilities are not explicitly named or their location revealed. It is a pre-market notification, implying this data was generated specifically for this submission.

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

• Not Applicable. This document describes the performance of a physical medical device (surgical face mask) through non-clinical laboratory testing, not a diagnostic AI device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of results is mentioned for these physical performance tests. The tests are conducted according to standardized laboratory procedures yielding objective measurements.

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

• Not Applicable. No clinical studies, especially MRMC studies comparing human readers with and without AI assistance, were performed. The submission explicitly states: "No clinical study is included in this submission."

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

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

• Not Applicable. The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (e.g., ASTM F2100 Level 3 requirements for fluid resistance, filtration efficiency, etc.) and biocompatibility standards (e.g., ISO 10993 series).

8. Sample Size for the Training Set

• Not Applicable. This device did not involve machine learning or AI, hence no training set.

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

• Not Applicable. No training set was used.

Ask a specific question about this device

The Surgical Face Masks, Model: EFDS-LS-Pn BLU is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. 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 mask provided non-sterile.

Surgical Face Masks, Model: EFMDS-L50Pn BLU

This document is a 510(k) clearance letter from the FDA for a surgical face mask. It does not contain information about a medical device that uses AI or a study proving its performance against acceptance criteria. Therefore, I cannot provide the requested information.

The document discusses:

• The device name: Surgical Face Masks, Model: EFMDS-L50Pn BLU
• Its regulatory classification (Class II, Product Code FXX, Regulation Number 21 CFR 878.4040)
• Its intended use: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material... for use in infection control practices to reduce the potential exposure to blood and body fluids."
• It clarifies that it's a "single-use, disposable mask provided non-sterile."

It is a clearance based on substantial equivalence to legally marketed predicate devices, not on a performance study demonstrating AI software's accuracy.

Therefore, I cannot answer the questions about acceptance criteria, study details, expert ground truth, MRMC studies, or standalone algorithm performance, as these are not relevant to the provided text.

Ask a specific question about this device

The Surgical 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 ininfection 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 nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). 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 Polyester 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 .iron and zinc. The proposed device(s) are sold nonsterile and are intended to be single use, disposable device.

This document describes the acceptance criteria and the study proving that the "Surgical Face Mask (L 175*95mm)" device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • For performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): 3 non-consecutive lots were tested, with a sample size of 32 per lot. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided document, but it represents samples from the manufactured product.
   • For biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The sample size is not explicitly stated as a number of devices/lots, but the tests were conducted on the "mask material" and "device components". The provenance is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. The tests conducted are objective, standardized laboratory tests measuring material properties and performance against established criteria, not subjective expert interpretations requiring a ground truth established by experts.

4. Adjudication Method for the Test Set: Not applicable. These were objective laboratory tests with quantitative or qualitative (Pass/Fail) results based on specific measurement protocols and acceptance thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done: No, an MRMC comparative effectiveness study was not done. The device is a surgical face mask, and performance is evaluated through material and physical property testing, not through human reader interpretation of medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done: Yes, the device's performance was evaluated in a "standalone" manner, meaning the device itself was subjected to physical and biological tests in a laboratory setting without human intervention beyond conducting the tests and measurements.

7. The Type of Ground Truth Used: The "ground truth" for the performance evaluation is based on established international and national standards for medical face masks and medical device biocompatibility. These include:

   • ASTM F2100 (Standard Specification for Performance of Materials Used In Medical Face Masks)
   • ASTM F1862 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
   • EN 14683 (Medical Face Masks-Requirements and Test Methods)
   • ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
   • ASTM F2299 (Determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres)
   • 16 CFR 1610 (Standard for the Flammability of clothing textiles)
   • ISO 10993-5 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
   • ISO 10993-10 (Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization)

8. The Sample Size for the Training Set: Not applicable. This device is a physical product (surgical face mask) and not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.

This document is a 510(k) Premarket Notification from Wuhan Huashida Protective Products Co., Ltd. for their Surgical Face Mask. It is a submission to the FDA demonstrating that their device is substantially equivalent to a legally marketed predicate device.

The premise of a 510(k) submission is to demonstrate "substantial equivalence' to a legally marketed device, not necessarily to prove the device's independent safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application. For a device like a surgical face mask, the FDA generally relies on performance testing against recognized standards rather than clinical studies, especially if the device is similar in design and materials to existing cleared devices.

Therefore, the information provided below is based on the provided document and tailored to how a 510(k) submission addresses "acceptance criteria" through non-clinical testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

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

The document provides a table of acceptance criteria and results from non-clinical performance and biocompatibility testing.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size:
  • For "Fluid Resistance Performance," the sample size is explicitly stated as 32 (29 out of 32 pass).
  • For other performance and biocompatibility tests, specific sample sizes are not explicitly stated in this summary document. They would typically be defined within the testing protocols for each standard (e.g., ASTM F2299, ASTM F2101, ISO 10993-5, etc.).
• Data Provenance: The tests were conducted by the manufacturer, Wuhan Huashida Protective Products Co., Ltd., in China. The data would be considered prospective as it involves new testing performed 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 type of information is not applicable to this submission. This document addresses a physical medical device (surgical face mask) evaluated through non-clinical performance testing against recognized standards. The "ground truth" for such devices is established by the specifications in the standards themselves (e.g., a BFE of >=98% is the target). There are no human "experts" establishing a subjective ground truth like in a diagnostic AI study. The results are quantitative measurements.

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

This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) are involved in interpreting medical images or data, and their disagreements need to be resolved to establish a "ground truth" or reference standard. This document pertains to physical device testing.

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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human interpretation plays a role. This submission pertains to a surgical face mask, which is a physical barrier device, not an AI diagnostic tool. The document explicitly states: "No clinical study is included in this submission."

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The product is a surgical face mask, not an algorithm. The testing performed is standalone in the sense that it's the mask's performance being measured directly against established standards.

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

The "ground truth" in this context is based on pre-defined, quantitative performance specifications established by relevant industry standards and regulatory guidance. For example:

• Fluid Resistance: Resistance to penetration by synthetic blood at a specified pressure (ASTM F1862).
• Filtration Efficiency (Particulate & Bacterial): Percentage of particles/bacteria filtered out (ASTM F2299, ASTM F2101).
• Differential Pressure: How easily air can pass through (EN 14683).
• Flammability: A classification based on burn rate (16 CFR 1610).
• Biocompatibility: Absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993 standards.

These standards define the 'truth' or expected performance for a surgical mask of a certain level.

8. The sample size for the training set

This is not applicable. This device is a manufactured medical product, not an AI algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device submission.

Ask a specific question about this device

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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of 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 Galvanized iron wire. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and performance of a Surgical Face Mask (K222483), not an AI-powered diagnostic device. Therefore, the questions related to AI/algorithm performance (such as MRMC studies, standalone performance, training set details, ground truth for training data, expert qualifications, and adjudication methods for specific diagnoses) are not applicable to this submission.

However, I can extract and present the acceptance criteria and study results for this medical device based on the non-clinical tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Synthetic Blood Penetration: "32 samples out of 32 pass" and "3 lots" are mentioned. This suggests at least 32 samples per lot were tested, across 3 lots.
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure): The sample size for these specific tests is not explicitly stated, but averages are provided, indicating multiple samples were tested for each.
• Biocompatibility (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly stated.
• Data Provenance: Not specified, but generally, such tests are conducted by certified testing laboratories commissioned by the manufacturer, Hubei Woozon Healthcare Co.,Ltd., located in China. These are non-clinical in vitro/in vivo tests on the device materials, not clinical data from patients.

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

This information is not applicable as the document pertains to the performance testing of a physical medical device (surgical face mask) against established industry standards. There is no diagnostic algorithm or ground truth to be established by experts in the context of this submission. The "ground truth" here is adherence to specified technical standards (e.g., minimum filtration efficiency, maximum differential pressure).

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Test results are determined by objective measurements per standard protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

This is not applicable. This submission concerns a physical medical device, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

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

This is not applicable. There is no algorithm for this device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is defined by established international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, ISO 10993 series, EN 14683 Annex C, 16 CFR 1610). The device is tested against these predefined criteria, and its performance is measured directly against those benchmark values.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical medical device undergoing performance testing.

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

This is not applicable for the reasons stated above.

Ask a specific question about this device

The Surgical 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 Surgical 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 Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of high density polyethylene. The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.

The provided document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is categorized as a "Level 3 Barrier" surgical face mask.

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It only indicates "Passed" for the results.

The data provenance is from non-clinical tests performed on the "Surgical Face Mask" manufactured by Xiantao Sanda Industrial Co., Ltd. The tests were conducted according to FDA guidance and international standards (ASTM, EN, ISO). The country of origin of the data is implied to be where the manufacturer is located or where the testing was contracted, which is China (Xiantao, Hubei). These are laboratory tests, not human data, so "retrospective or prospective" does not directly apply in the same way it would for clinical studies.

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

This section is not applicable as the ground truth for device performance in this context is established by objective, standardized test methodologies and established acceptance criteria from recognized international standards (ASTM, EN, ISO) and FDA guidance documents. There are no human experts establishing ground truth for these physical and biological performance tests.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication method" primarily refers to expert review processes for cases, which is relevant for clinical studies or image-based diagnostic AI. For non-clinical device performance tests like those described (e.g., filtration efficiency, breathability, flammability), the results are quantitative and objective, determined by the test procedures outlined in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in the context of AI assistance. This document describes a physical medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing.

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

This section is not applicable. This document describes a physical surgical face mask, not an algorithm or AI-based device. The term "standalone performance" typically refers to the performance of an algorithm without human intervention, which does not apply here.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established scientific and engineering standards and their specified test methodologies. For example:

• Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101, using a biological aerosol of Staphylococcus Aureus. The "ground truth" is the empirically measured percentage of bacteria filtered.
• Differential Pressure: Measured according to EN 14683:2019 Annex C, the "ground truth" is the physical measurement of pressure drop across the mask.
• Sub-micron Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17, using latex spheres. The "ground truth" is the empirically measured percentage of particles filtered.
• Resistance to Penetration by Synthetic Blood: Measured according to ASTM F1862-17. The "ground truth" is whether the synthetic blood penetrates the material at a specific pressure.
• Flammability: Assessed according to 16 CFR Part 1610-2008. The "ground truth" is the material's flammability classification.
• Biocompatibility: Evaluated according to ISO 10993 series (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation). The "ground truth" is the biological response observed in standardized in vitro or in vivo tests.

These tests provide objective, measurable outcomes against predefined criteria.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct physical and biological testing.

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

This section is not applicable for the same reason as point 8; there is no training set mentioned or implied for a physical medical device like a surgical face mask.

Ask a specific question about this device

The Surgical 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(s), provided non-sterile.

The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is 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 ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.

The provided text describes the regulatory clearance for a Surgical Face Mask (K222529). This is a medical device, not an AI/ML-driven device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML systems (such as expert consensus, MRMC studies, training set details, or an 'algorithm only' performance) are not applicable.

The acceptance criteria here pertain to the physical and performance characteristics of the surgical face mask, comparing it to established industry standards (ASTM, ISO, EN, CFR) for medical face masks. The study proving the device meets these criteria is a non-clinical performance and biocompatibility testing.

Here's the information extracted from the provided text, adapted to the requested format where applicable, and noting when a requested AI/ML specific criterion is not relevant to this type of device:

Device Name: Surgical Face Mask (Xiantao Rayxin Medical Products Co., Ltd.)
Regulatory Classification: Class II Surgical Apparel (Product Code FXX, 21 CFR 878.4040)
Predicate Device: Surgical Face Mask (K212368, Anhui Tiankang Medical Technology Co., Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Synthetic Blood Penetration: 32 samples per test condition for each of 3 lots.
• Other Performance Tests (PFE, BFE, Delta P, Flammability): Specific sample sizes are not explicitly stated for each of these, but performance is reported as averages or 'Pass' implying multiple samples were tested to demonstrate compliance with the standards.
• Biocompatibility Tests: Sample sizes are not explicitly stated.
• Data Provenance: The tests appear to be laboratory performance tests, not clinical data from patients. The sponsor, Xiantao Rayxin Medical Products Co., Ltd., is based in China. The specific location where these tests were performed is not detailed, but it would typically be a certified testing laboratory. The data is based on prospective testing of the manufactured devices to the specified standards.

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

• Not applicable. This is a hardware device where ground truth is established through standardized laboratory measurements and physical properties, not human interpretation or expert consensus. The "ground truth" is defined by the performance standards themselves (e.g., a specific percentage filtration, a specific pressure differential).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3. Testing involves objective measurements against established physical and chemical standards, not subjective interpretations requiring adjudication.

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

• No. This is not an AI/ML-assisted diagnostic device, so an MRMC study is not relevant. The device's effectiveness is based on its physical barrier properties and breathability, not its ability to assist human readers.

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

• No. This is a physical product (surgical face mask), not an algorithm or software. The concept of "standalone performance" for an algorithm is not applicable here.

7. The Type of Ground Truth Used:

• Standardized Physical and Chemical Measurements & Definitions: Ground truth is defined by the requirements of the specific ASTM, ISO, EN, and CFR standards referenced. For example, "Level 1 pass at ≥95%" for BFE means that any value of 95% or higher, as measured by the ASTM F2101 method, constitutes a 'pass'. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" phase.

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

• Not applicable. See point 8.

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The Surgical Face 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. The Surgical 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 Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.

The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.

The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The document provided is a 510(k) Pre-market Notification for a Surgical Face Mask (Non-sterile). It outlines the non-clinical testing performed to establish substantial equivalence to a predicate device. This type of submission relies on performance testing against established standards rather than clinical studies for device functionality.

Here's a breakdown of the requested information 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 (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Performance Tests: For Bacterial Filtration Efficiency, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flammability, 3 non-consecutive lots were tested, with a sample size of 32 per lot.
• Sample Size for Biocompatibility Tests: The exact sample size for cytotoxicity, irritation, and sensitization tests is not specified, but the tests were performed on the mask material.
• Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the applicant is from China (Xiantao Junhui Plastic Products Co., Ltd.), it is highly probable that the testing was conducted in China or a region following these international standards. The testing is non-clinical performance testing rather than human subject data.

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 section is not applicable. The device is a surgical face mask, and its performance is evaluated through standardized non-clinical laboratory tests (e.g., filtration efficiency, breathability, fluid resistance, flammability, biocompatibility) based on criteria defined in established standards (ASTM, EN, ISO, CFR). There is no "ground truth" in the clinical sense established by human experts for these types of tests. The "ground truth" is the objective measurement against the specified standard's criteria.

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 refer to methods used to resolve discrepancies among multiple expert readers or scorers, typically in medical imaging or clinical trials. As stated above, the device performance is determined by 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 section is not applicable. MRMC studies and AI assistance are relevant to diagnostic or interpretation devices, particularly in medical imaging. The device in question is a surgical face mask, which does not involve human readers interpreting data or AI assistance.

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

This section is not applicable. "Standalone performance" or "algorithm only" refers to the performance of an AI or software algorithm without human intervention, again typically for diagnostic or interpretative devices. The surgical face mask does not use an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements against established international and national standards. For example:

• For Bacterial Filtration Efficiency, the ground truth is the measured percentage of bacteria filtered, compared against the ≥98% standard.
• For Resistance to Penetration by Synthetic Blood, the ground truth is the number of samples passing the test at 160 mmHg, compared against the 29 out of 32 pass standard.
• For Biocompatibility, the ground truth is determined by the results of standardized tests for cytotoxicity, irritation, and sensitization, compared against criteria like "non-cytotoxic," "negligibly irritating," and "non-sensitizing."

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (a surgical face mask) and does not involve machine learning or AI, and therefore no training set.

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

This section 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 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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