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The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical 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 device(s), provided sterile.

The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical 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 device(s), provided sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.

The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.

The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.

The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.

The provided document is a 510(k) Summary for a medical device, a "Disposable Medical Surgical Mask". It details the device's technical characteristics, performance, and biocompatibility compared to a predicate device, as well as the non-clinical tests performed to demonstrate substantial equivalence.

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)

The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for fluid resistance). It refers to the tests being conducted per the cited ASTM, EN, and ISO standards, which would typically specify sample sizes. The data provenance is not explicitly mentioned as "country of origin of the data" or "retrospective/prospective," but the manufacturer is based in China: Hubei Huaqiang High-Tech CO., LTD., No.499 DongLin Road, Yichang, Hubei Province, 443000, China. The testing described is non-clinical performance and biocompatibility testing of the device, not a human study.

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 testing described in the document. The tests performed are objective, standardized laboratory tests (e.g., measuring filtration efficiency, fluid resistance) whose "ground truth" is determined by the physical properties of the device and the methodologies of the test standards, not by expert interpretation.

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

Not applicable. This is for direct performance measurements of physical characteristics, not expert adjudication of clinical outcomes.

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 device is a medical surgical mask, not an AI-powered 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

Not applicable, as this device is not an algorithm or AI system.

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

The "ground truth" for this device's performance is established by the specified international and national standards (ASTM, EN, ISO, CFR) and their defined test methodologies. The results reflect the physical and biological properties of the mask as measured by accredited laboratory procedures, not by expert consensus, pathology, or outcomes data in a clinical setting.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable for the same reason as above.

Ask a specific question about this device

The Disposable Medical 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 a single use, disposable device(s), provided sterile.

The Disposable Medical Surgical Mask is composed of mask body, nose clip and ear loop. The body of the 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 nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the Disposable Medical Surgical Mask is 17.5*9.5cm with tolerance +/- 0.2cm, the length of the ear loop is 17cm with tolerance +/-5 cm, and the length of the nose clip should no less than 8.0cm.

The outer layer of Disposable Medical Surgical Mask will be provided in blue, the inner layer of the Disposable Medical Surgical Mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

This document describes the premarket notification for a Disposable Medical Surgical Mask. It does not contain information about an AI/ML powered device, so I cannot answer your questions as they pertain to the criteria for AI/ML powered medical devices.

The document discusses the substantial equivalence of the proposed device to a legally marketed predicate device, focusing on material composition, intended use, and performance characteristics consistent with surgical masks.

However, I can extract the acceptance criteria and performance results for this non-AI medical device.

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

Biocompatibility Comparison

The following questions cannot be answered from the provided text, as the document pertains to a medical device (surgical mask) that is not AI/ML-powered:

2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the from the transfer of microorganisms, body fluids and particulate material. The 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 device, provided nonsterile.

The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The ear loop is made of Knited nylon and spandex. The nose clip contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Synthetic iron wire, PP and PE. The "Disposable Medical Surgical Mask" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.

The provided text describes a submission for a Disposable Medical Surgical Mask seeking FDA clearance (K210348) by demonstrating substantial equivalence to a predicate device (K202463).

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

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

The provided document includes two tables that effectively serve this purpose, one for general performance and another for biocompatibility.

Performance Test Results:

Biocompatibility Test Results:

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

• Sample Size: For performance testing (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability), the testing was performed using 3 nonconsecutive lots of 32 samples per lot.
• Data Provenance: Not explicitly stated regarding country of origin or specific lab accreditation, but the tests were "conducted below testing" for the proposed device, suggesting the tests were specifically performed for this submission. The lack of further detail on provenance beyond "Proposed Device" suggests these are new tests conducted for the submission. The classification and purpose indicate these are likely laboratory tests rather than human clinical data. The submission is from Weihai Dishang Medical Technology Co., Ltd in Weihai, Shandong, China.

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 device and study. The "ground truth" for surgical masks is established by objective measurements based on specified ASTM and ISO standards (e.g., filtration efficiency, differential pressure). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for medical images. The acceptance criteria themselves serve as the ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, primarily in imaging studies where multiple readers interpret cases and disagreements need to be resolved. For objective laboratory tests like those performed on a surgical mask, there is no subjective interpretation requiring an adjudication process.

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. This is a submission for a physical medical device (surgical mask), not an AI-powered diagnostic tool, therefore no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established objective laboratory test results that meet internationally recognized standards (ASTM, EN, ISO) for performance and biocompatibility. These standards define the acceptable range for parameters like filtration efficiency, pressure differential, and biological reactions.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of testing a physical medical device like a surgical mask. These are direct performance and safety evaluations.

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

This information is not applicable as there is no training set involved.

Ask a specific question about this device

The Disposable medical surgical mask is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical 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 device(s), provided non-sterile.

The Disposable medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical 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 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 have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.

The Disposable medical surgical mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated steel wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The acceptance criteria and device performance for the "Disposable medical surgical mask" (K212097) are detailed in the provided tables.

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM F1862 (Resistance to penetration by synthetic blood): The test involved 32 samples, "32 out of 32 pass at 160 mmHg."
• For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly stated in the provided document beyond the quantitative results.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are non-clinical (laboratory) tests performed on the device itself.

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

This submission concerns a medical mask, and the evaluation is based on non-clinical performance and biocompatibility testing against established ASTM, ISO, EN, and CFR standards. Therefore, clinical expert ground truth is not applicable in the context of this device's submission and approval process. The "ground truth" is defined by the requirements of the standards themselves.

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

Not applicable. This is not a clinical study involving human readers or cases requiring adjudication. The device performance is assessed through standardized laboratory 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:

Not applicable. This device is a disposable medical surgical mask, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical product (mask), not an algorithm. The performance is inherent to the material and design of the mask as tested in laboratory settings.

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

The "ground truth" for the performance evaluation of the mask is based on established national and international standards for medical face masks and biological evaluation of medical devices. These standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993) define the methodologies and acceptance criteria for specific physical, mechanical, and biological properties.

8. The sample size for the training set:

Not applicable. This is a physical medical device (mask), not a machine learning model. There is no concept of a "training set" for its evaluation.

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

Not applicable, as there is no training set for this type of device. The performance is measured directly against predefined standard criteria.

Ask a specific question about this device

The disposable medical surgical 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, provided as sterile and non-sterile.

The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.

The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask. This type of device is a physical product and not an AI/ML software device. Therefore, the questions regarding AI/ML specific criteria (such as training sets, ground truth establishment methods, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The document details the acceptance criteria and a study proving the device meets these criteria for a medical mask. The study focuses on bench testing and biocompatibility testing, which are standard for physical medical devices of this type.

Here’s the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fluid Resistance (ASTM F 1862-17): The acceptance criteria states "29 out of 32 pass at 160 mmHg," indicating a sample size of 32 units tested. The results are reported for three different lots (Lot 1#, Lot 2#, Lot 3#), suggesting batch testing.
• Other tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability): While specific sample sizes for these tests are not explicitly stated in the summary table, results are provided for three different "lots" (Lot 1#, Lot 2#, Lot 3#). This implies multiple samples were taken from each lot and tested to derive the reported ranges.
• Biocompatibility tests (Cytotoxicity, Sensitization, Irritation): The results are reported as meeting the criteria "Under the conditions of the study," without specific sample numbers mentioned in the summary, but these are standard lab tests typically conducted on a sufficient number of samples as per the ISO standards.
• Data Provenance: The tests were conducted by Chongqing COE Display Technology Co., Ltd. (China). The data is prospective as it's generated specifically for this 510(k) submission to demonstrate compliance with standards.

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

• Not Applicable. This is a physical medical device (surgical mask), not an AI/ML diagnostic tool. Ground truth is established through standardized laboratory testing protocols (e.g., ASTM, ISO) and physical measurements/observations, not human expert interpretation of images or data.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device, testing involves objective laboratory measurements and adherence to pre-defined standard protocols, not human adjudication of subjective interpretations.

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

• No. MRMC studies are relevant for diagnostic devices where human readers interpret medical data (e.g., images). This device is a physical protective barrier, and its effectiveness is determined through quantifiable physical and biological barrier properties, not diagnostic accuracy by human readers.

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

• Not Applicable. This is not an algorithm or software device. Its performance is intrinsic to the device's material and design, measured in a laboratory setting.

7. The Type of Ground Truth Used

The ground truth for this device is based on objective, measurable performance criteria derived from recognized national and international standards for medical face masks and biocompatibility:

• Standardized Bench Test Measurements: e.g., Fluid Resistance (ASTM F1862), Bacterial Filtration Efficiency (ASTM F2101), Particulate Filtration Efficiency (ASTM F2299), Differential Pressure (EN 14683), Flammability (16 CFR Part 1610).
• Biocompatibility Lab Results: e.g., Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10). These involve established biological testing methods.

8. The Sample Size for the Training Set

• Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.

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

• Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.

Ask a specific question about this device

The Disposable Medical Surgical 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 proposed device(s) are blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) 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 model of proposed device, ear loops, is 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 contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polyethylene coated steel wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the 510(k) premarket notification for a Disposable Medical Surgical Mask (K202511). This is a regulatory submission for a medical device, and as such, the "study" referred to is primarily a set of performance tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical trial or an AI algorithm validation study.

Therefore, many of the requested elements regarding AI performance, human reader studies, and sophisticated ground truth establishment are not applicable to this type of medical device submission. The device in question is a physical product (a surgical mask), not an AI algorithm or diagnostic tool.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards for surgical masks, primarily ASTM F2100 levels. The study demonstrates performance against these criteria.

Study Details (Applicable to a Medical Device Performance Test)

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

• Sample Size:
  • For Fluid Resistance Performance (ASTM F1862): 32 samples were tested.
• Data Provenance: The tests were conducted according to established ASTM and MIL-M standards. The country of origin of the data is not explicitly stated beyond the manufacturer's location in China. The data is retrospective in the sense that it's a test of the manufactured product to demonstrate compliance.

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

• This is not applicable as this is a performance test for a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is defined by the objective measurement protocols of the ASTM and MIL standards.

4. Adjudication method for the test set:

• Not applicable for a physical device performance test. Test results are quantitative measurements against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). This submission is for a surgical mask.

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

• Not applicable. This is not an AI algorithm. The performance tests (e.g., filtration efficiency, fluid resistance) are "standalone" in the sense that they are objective measurements of the mask's physical properties.

7. The type of ground truth used:

• The ground truth is based on objective measurement standards and specifications (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36954C, 16 CFR 1610, ISO 10993-1). For example, for "Fluid Resistance," the ground truth is the pressure at which fluid penetrates the mask when challenged with a synthetic blood spray.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model that requires a training set. The manufacturing process itself could be seen as "training" in a very abstract sense, but not in the context of machine learning.

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

• Not applicable. As above, this is not an AI model with a training set and associated ground truth.

Ask a specific question about this device

The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.

The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.

This document is a 510(k) Premarket Notification for a medical device (Disposable Medical Surgical Masks). It is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to the predicate device based on non-clinical performance and specifications.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML-based medical devices (like MRMC studies, expert adjudication, separate training/test sets for AI, human-in-the-loop performance, etc.) are not applicable to this document, as it describes a physical medical device (surgical masks) and its performance based on standardized material testing.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on meeting established industry standards for surgical masks, primarily ASTM F2100-19 for medical face mask materials, and other related standards (ISO 10993 for biocompatibility, ASTM F1862 for fluid resistance, etc.). The reported device performance is presented in comparison to these standards and a predicate device.

Table of Acceptance Criteria and Reported Device Performance (Summary from Section 6 and 7):

Study Details (for a physical product, not an AI/ML algorithm)

It's important to reiterate that this is a submission for a physical medical device (surgical mask), not an AI/ML algorithm. Therefore, many standard AI/ML study components do not apply.

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

   • Test Set: No explicit "test set" in the AI/ML sense is mentioned. Instead, samples of the manufactured masks were subjected to various standardized non-clinical tests. The document does not specify the number of masks or samples tested for each criterion (e.g., how many masks were tested for BFE, how many for fluid resistance).
   • Data Provenance: The tests were conducted by the manufacturer/sponsor (Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd., China) as part of their verification process for the 510(k) submission. This would be considered "prospective" in the sense that the tests were performed specifically for this submission, on samples of the device.

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

   • Not Applicable. Ground truth in the context of a physical device like a surgical mask is established by validated laboratory testing methods and compliance with published standards (e.g., ASTM, ISO). There are no human "experts" establishing a subjective "ground truth" for each mask. The "ground truth" is the quantitative result from the standardized test.

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

   • None. Adjudication methods are relevant for subjective interpretations, typically in image analysis or clinical assessments. For standardized physical material testing, the results are quantitative and objective measurements from the validated test methods.

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 device, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This is a physical device, not an AI algorithm. Its performance is inherent to its materials and construction.

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

   • Objective Laboratory Test Results against Established Standards: The "ground truth" for the performance of the Disposable Medical Surgical Masks is the objective measurement obtained through specific, validated laboratory test methods (e.g., ASTM F2101 for BFE, ASTM F1862 for fluid resistance) and comparison against the specified acceptance criteria within those standards (e.g., ASTM F2100 Level 3 requirements).

7. The sample size for the training set:

   • Not Applicable. This is a manufactured physical device, not an AI/ML model that requires a training set. The manufacturing process is analogous to a "training" phase where the design and materials are refined to meet specifications.

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

   • Not Applicable. As above, no training set for an AI algorithm. The manufacturing process of a physical device involves quality control and adherence to specifications to ensure the final product meets its intended performance, which is then verified through non-clinical testing.

Ask a specific question about this device

The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is 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.

The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.

The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask, which is a Class II medical device. The document details the device's characteristics, intended use, and comparative analysis against a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document does not describe an AI/ML-driven medical device, and therefore, many of the requested criteria regarding AI model evaluation (e.g., training set, ground truth experts, MRMC studies) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, as detailed in the non-clinical performance testing section.

Here's the breakdown based on the provided text:

Device Type: Disposable Medical Surgical Mask (Not an AI/ML device)

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

The device performance is evaluated against the ASTM F2100-19 standard for medical face masks, along with other relevant standards for specific tests.

Biocompatibility Testing:

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

• Sample Size:
  • For Fluid Resistance (ASTM F1862): 32 samples were tested, with 29 passing the 160 mmHg threshold.
  • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The specific sample size per test is not explicitly stated but is implied to be sufficient to meet the standards (e.g., "Pass" results).
  • For Biocompatibility testing: The sample size for each test (Cytotoxicity, Irritation, Sensitization) is not explicitly stated.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that non-clinical tests were conducted. Given the nature of performance and biocompatibility testing for a physical medical product, these are almost certainly prospective laboratory tests following standardized protocols.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) does not apply here. The "ground truth" for this device is established by the results of standardized laboratory tests conducted according to established protocols (e.g., ASTM, ISO standards).

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

• Not Applicable. As this is a performance evaluation of a physical device against predefined quantitative standards, an adjudication method for human interpretation is not relevant. The results are objective measurements from laboratory equipment.

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 device is a surgical mask, not an AI-driven diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical device, not a software algorithm.

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

• Standardized Test Results / Quantitative Measurements: The "ground truth" is based on the objective outcomes of laboratory tests performed according to recognized industry standards (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ASTM F1862 for Fluid Resistance). These standards define the methodology and the acceptable performance thresholds.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.

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