Search Results

The Procedure mask/Surgical mask/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, provided non-sterile.

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:

Table 1: Acceptance Criteria and Reported Device Performance

Study Details (Applicable to Face Mask Device)

Given that the device is a medical face mask, the "study" primarily consists of non-clinical, laboratory-based performance and biocompatibility testing, not clinical trials or AI performance evaluations as would be done for software.

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

   • Sample Size: Not explicitly stated in terms of number of masks or test replicates for each test, but standard test methodologies (e.g., ASTM F1862/F1862M-24, ASTM F2101-23) typically specify a minimum number of samples. The results are given for specific "lots" (e.g., Yellow mask (Level 1), White mask (Level 1), Blue mask (Level 1, 2, 3)), implying that multiple samples from these production lots were tested.
   • Data Provenance: Not explicitly stated. The manufacturer is Winner Medical Co., Ltd. from Shenzhen, China. This indicates the testing was likely conducted in China or by labs accredited to perform these standards. The tests are "Non clinical tests," meaning they are laboratory experiments rather than human subject or retrospective studies.

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

   • Not Applicable. For this type of device (medical mask), "ground truth" is established by adherence to validated, objective, and standardized laboratory test methodologies and measurements, not by expert human interpretation (like in imaging for AI). The tests measure physical and biological properties directly.

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

   • Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., reading medical images) where there can be inter-reader variability. These are objective, quantitative laboratory tests.

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 medical device (mask), not an AI-powered diagnostic tool. MRMC studies are used to assess the performance of AI systems in combination with human readers.

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

   • Not Applicable. This is a physical medical device (mask), not an algorithm.

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

   • Objective Laboratory Measurements/Standards. The "ground truth" for this device is based on the objective measurements obtained through the specified ASTM, EN, CFR, and ISO standards (e.g., bacterial filtration efficiency percentage, differential pressure values, absence of penetration by synthetic blood, flammability class, cellular toxicity grading, sensitization response). These are empirical, quantitative, and qualitative results from standardized test protocols.

7. The sample size for the training set:

   • Not Applicable. This is a physical device being tested against performance standards, not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As above, no training set for an algorithm is involved.

Ask a specific question about this device

The Procedure mask/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 is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

This document is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). The information provided demonstrates that the device meets the acceptance criteria through non-clinical testing.

Here's the breakdown of your 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 for each non-clinical test. However, it indicates that the tests were performed in accordance with the referenced standards (e.g., ASTM F1862/F1862M, ASTM F2299/F2299M-03, ASTM F2101, EN 14683, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards typically define appropriate sample sizes for such tests.

The provenance of the data is that the tests were performed on the proposed device by Winner Medical Co., Ltd. The company is located in Shenzhen, Guangdong, China. The data is prospective, generated specifically for this 510(k) submission.

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 is a non-clinical study for a physical device (surgical mask) based on standardized test methods for material performance and biocompatibility. Therefore, the "ground truth" is defined by the established acceptance criteria within those standards, as measured by laboratory testing. There are no "experts" in the sense of medical professionals establishing ground truth from observational data; rather, the expertise lies in the certified laboratories and personnel performing the standardized tests.

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

This is not applicable for non-clinical performance testing of a physical device. The results are obtained through standardized laboratory measurements.

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 is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The ground truth for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (ASTM, EN, ISO, CFR) for medical face masks and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. As noted above, there is no training set for this device.

Ask a specific question about this device

The Procedure 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. All models are single use, disposable devices, provided non-sterile.

Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

The provided document contains information on the acceptance criteria and performance testing for a medical device (Procedure Mask). However, it does not include information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML or diagnostic devices, such as:

• Sample size for a test set (it mentions testing on "three non-consecutive production lots" for the ASTM performance tests, which refers to the mask itself, not a dataset for an AI model).
• Data provenance for the test set.
• Number of experts or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI assistance.
• Standalone performance (for an AI algorithm).
• Type of ground truth (beyond the mask's physical performance).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a Procedure Mask, a physical medical device, not an AI/ML-driven diagnostic or image analysis device. Therefore, the questions related to AI/ML study design are not applicable to the information contained in this document.

The acceptance criteria here pertain to the physical and functional performance of the mask as per relevant ASTM and ISO standards for medical face mask materials and biocompatibility.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM F2100 levels (Level 1, Level 2, Level 3) which define performance requirements for medical face masks. The tables within the document compare the proposed device's performance to the predicate device's performance against these standards.

Model GFM31A (ASTM Level 1)

*GFM31A uses the same materials as GFM43A, and GFM43A (a Level 3 mask) was subjected to all biocompatibility tests as the "worst case" model. GFM31A was specifically tested for cytotoxicity only.

Model GFM42A (ASTM Level 2)

*GFM42A uses identical materials to GFM43A, which was used for irritation and sensitization testing as a "worst case" model due to an additional layer of material.

Model GFM43A (ASTM Level 3)

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

• Test Set Sample Size: For the ASTM performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure), the tests were conducted "in triplicate on samples obtained from three non-consecutive production lots." For Fluid Resistance (ASTM F1862), it states "32 out of 32 passed at X mmHg, 3 lots," implying a sample size of 32 per lot for that specific test.
• Data Provenance: Not specified, but generally, such tests are conducted by certified laboratories as per industry standards. No information regarding country of origin or retrospective/prospective nature is given, as it's not relevant for a physical product's performance testing in this context.

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

• Not applicable as this is a physical product's performance testing based on established standards (ASTM, EN, ISO). Ground truth is the defined standard performance, not expert opinion.

4. Adjudication method for the test set:

• Not applicable. Performance is measured directly against predefined quantitative 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:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The ground truth is based on established industry standards and physical measurements. For example, for fluid resistance, the standard specifies a certain pressure; for filtration efficiency, it specifies a minimum percentage. For biocompatibility, it's defined by the absence of cytotoxicity, irritation, and sensitization as per ISO 10993.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

This document describes the performance of a medical device, specifically Procedure Masks with Ear Loops and Surgical Masks with Ties, submitted for FDA 510(k) clearance (K221134). The device is compared to a predicate device (K202899) to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on ASTM F2100-19 for medical face mask performance, and other relevant standards like ASTM F1862/F1862M-17 (Fluid Resistance), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 + AC:2019 Annex C (Differential Pressure), 16 CFR 1610 (Flammability), ISO 10993-5: 2009 (Cytotoxicity), and ISO 10993-10: 2010 (Irritation and Sensitization).

There are two tables provided in the document:

• Table 1: Comparison of Performance Testing for Proposed ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate Device
• Table 2: Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device

Table 1: ASTM Level 1 Masks (PM3001 & SM3001)

Table 2: ASTM Level 3 Masks (PM3003 & SM3003)

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

• Sample Size for Test Set: For each non-clinical performance test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the tests were conducted on 32 samples from 3 non-consecutive lots, totaling 96 samples for each test. For cytotoxicity, irritation, and sensitization, specific sample sizes are not explicitly stated, but the results indicate evaluation was performed.
• Data Provenance: The document does not specify the country of origin of the data. It indicates these are "non-clinical testing" results, which implies laboratory testing. It does not state whether the data is retrospective or prospective, but as it concerns performance of the newly manufactured device, it would inherently be prospective testing.

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

No information is provided regarding human experts or ground truth establishment in the context of the performance tests for the masks. The "ground truth" for these tests is the quantitative measurement against established ASTM/EN/CFR standards, which are objective and do not require expert human interpretation in the way medical image analysis might.

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and yield quantitative results against defined criteria, not subjective interpretations requiring adjudication.

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

No. The document explicitly states: "No clinical testing is included in this submission." This type of study would typically be done for AI/CAD devices, not for basic personal protective equipment like masks where performance is evaluated through standardized material tests.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Not applicable. This is a physical medical device (mask), not an algorithm or software.

7. Type of Ground Truth Used

The ground truth for the performance tests is based on pre-defined, internationally recognized standards and test methods (e.g., ASTM, EN, CFR, ISO). Each test has a specific methodology and acceptance criterion for properties like filtration efficiency, fluid resistance, breathability, and biological safety.

8. Sample Size for the Training Set

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

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

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device

The Procedure mask/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 is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.

Therefore, I cannot extract information related to:

• Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
• Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
• Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
• Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
• Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.

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 general "sample sizes" in terms of number of patient cases or images, as this is a physical product's performance validation. The "tests" refer to laboratory evaluations of material properties. The provenance of the testing data is not explicitly stated beyond being "non-clinical tests" conducted to verify compliance with standards. It does not indicate country of origin for test data or whether tests were retrospective or prospective, as these are material property tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device (a face mask) is established by adherence to recognized international and national standards (e.g., ASTM, EN, ISO, CFR) for material performance, not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring human adjudication.

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 MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for physical medical devices like face masks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the results of standardized physical and biological tests, which measure specific material properties and performance characteristics against predefined thresholds in the cited standards (e.g., ASTM F1862/F1862M for synthetic blood penetration, ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility).

8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model.

Ask a specific question about this device

The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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 Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

Ask a specific question about this device

The Procedure Masks / 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 Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) Premarket Notification for a Procedure Mask/Surgical Mask. It describes the device's technical specifications and performance testing. However, it is important to note that this document is for a medical device (a mask) and not a software or AI-based device. Therefore, many of the requested elements for describing an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details, are not applicable in this context.

The document focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device by meeting certain performance criteria.

Here's the information derived from the document that is applicable to your request, formatted as closely as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against the ASTM F2100 requirements for Level 1 and Level 3 masks.

Acceptance Criteria and Device Performance for Level 1 Masks:

Acceptance Criteria and Device Performance for Level 3 Masks:

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 Test Set:
  • Fluid Resistance (ASTM F1862): 32 samples per lot, across 3 lots for both Level 1 and Level 3 masks. (e.g., "32 out of 32 passed at 80 mmHg, 3 lots")
  • Particulate Filtration Efficiency (ASTM F2299): Not explicitly stated how many individual samples were tested, but results are reported as percentages for "3 lots."
  • Bacterial Filtration Efficiency (ASTM F2101): Not explicitly stated how many individual samples were tested, but results are reported as percentages for "3 lots."
  • Differential Pressure (EN 14683): Not explicitly stated how many individual samples were tested per lot, but results are reported with three values for each model (e.g., "2.9, 2.8, 2.7 mmH₂O/cm²"), likely representing different samples or averages across lots.
  • Flammability (16 CFR 1610): Not explicitly stated.
• Data Provenance: The document implies that the tests were conducted by the manufacturer or a third-party lab on samples of their manufactured masks. The manufacturer is KENPAX INTERNATIONAL LIMITED, located in Hong Kong, China. The testing therefore likely occurred in China or at a contract lab. The data is prospective in the sense that these tests were performed on new device samples to demonstrate compliance.

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 type of information is not applicable. The "ground truth" for medical masks is established by validated standardized test methods (e.g., ASTM standards) and not by expert clinical consensus. The performance is measured objectively using specified laboratory procedures.

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

Not applicable, as this is objective performance testing against a standard, not classification based on expert opinions.

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 is for a physical medical device (mask), not an AI system.

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

Not applicable. This is for a physical medical device (mask), not an AI system. The tests are for the physical properties of the mask.

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

The "ground truth" is based on established engineering and materials science standards for mask performance (e.g., flow rates, particle sizes, microbial viability, fluid pressure) as defined by organizations like ASTM and EN. For example, the ground truth for Bacterial Filtration Efficiency (BFE) is derived from the established protocol of the ASTM F2101 standard, which dictates the aerosolization of Staphylococcus aureus and measurement of filtration effectiveness.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. As above, no AI model or training set is involved.

Ask a specific question about this device

Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial.

Procedure Masks PM 4-301 + Pm4-31

This document is a 510(k) premarket notification decision letter from the FDA regarding "Procedure Masks: PM4-301 and PM4-304" manufactured by Primline Medical Products, Incorporated. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.

Therefore, I cannot provide the requested information from the given input.

Ask a specific question about this device