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510(k) Data Aggregation
(205 days)
The 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 masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile.
XX0009 Ear loop Level: Level 1, Level 2 and Level 3
XX0008 Tie-on Level: Level 1, Level 2 and Level 3
XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3
XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3
The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece 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 proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.
The provided text is a 510(k) Summary for Surgical Masks (K212120), focusing on demonstrating substantial equivalence to a predicate device (K160269) through non-clinical testing. It does not describe a study involving an AI (Artificial Intelligence) or medical imaging device, nor does it involve a multi-reader multi-case (MRMC) study. Therefore, many of the requested details, such as human reader improvement with AI assistance, ground truth establishment for AI training/test sets, or the number of experts for adjudication, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, specifically for the surgical masks.
Acceptance Criteria and Device Performance for Surgical Masks (Based on Non-Clinical Tests)
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical tests were conducted to verify that the proposed device met all design specifications. The performance levels (Level 1, Level 2, Level 3) refer to classifications defined by ASTM F2100: 2019 "Standard Specification for Performance of Materials Used in Medical Face Masks."
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Particulate Filtration Efficiency (PFE) | Determines the particle filtration efficiency (PFE) of the test article (ASTM F2299/F2299M-03 (2017)) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1: Pass at 96.17%Level 2: Pass at 98.95%Level 3: Pass at 99.06% |
| Bacterial Filtration Efficiency (BFE) | Determines the bacterial filtration efficiency (BFE) of the test article using a biological aerosol of Staphylococcus aureus (ASTM F2101: 2019) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1: Pass at 96.80%Level 2: Pass at 98.90%Level 3: Pass at 99.04% |
| Differential Pressure | Measures the breathability of the mask (EN 14683:2019+AC: 2019 Annex C) | Level 1: <5.0 mmH₂O/cm²Level 2: <6.0 mmH₂O/cm²Level 3: <6.0 mmH₂O/cm² | Level 1: Pass at 4.0 mmH₂O/cm²Level 2: Pass at 5.1 mmH₂O/cm²Level 3: Pass at 5.2 mmH₂O/cm² |
| Flammability | Determines the flammability of the mask material (16 CFR Part 1610) | Class 1 | Class 1 |
| Resistance to Penetration by Synthetic Blood | Evaluates the effectiveness of the sample from possible exposure to blood and other body fluids (ASTM F1862/F1862M: 2017) | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg |
| Cytotoxicity | Evaluates the cytotoxicity of the test sample (ISO 10993-5:2009) | Viability ≥ 70% of the blank; 50% extract viability ≥ 100% extract viability | Viability ≥ 70% of the blank; 50% extract had higher viability than 100% extract. Proposed device was non-cytotoxic. |
| Sensitization | Evaluates the sensitization potential of the test sample (ISO 10993-10:2010) | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | Evaluates the irritation potential of the test sample (ISO 10993-10:2010) | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of masks or material samples) used for each non-clinical test. These tests are typically conducted on a statistically significant number of samples per batch or according to the specific standard's requirements, but the exact count is not detailed in this summary.
The provenance of the data is that these are non-clinical laboratory test results performed to demonstrate compliance with recognized consensus standards (ASTM, ISO, EN, CFR). The tests were performed for a Chinese manufacturer (Hubei Xinxin Non-woven Co., Ltd.) for submission to the U.S. FDA. The data is implicitly prospective testing conducted specifically for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. These are physical and biological performance tests on a device (surgical masks), not image-based diagnostic tests or AI performance evaluations requiring expert radiologists or similar medical professionals for ground truth establishment. The "ground truth" for these tests is defined by the objective measurement results according to the specified standard methods.
4. Adjudication Method for the Test Set
Not applicable. This is not a study that requires human adjudication of subjective data. The results are based on objective, standardized laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission is for surgical masks, not an AI or imaging device that would typically involve a human-in-the-loop diagnostic task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical mask), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the surgical masks is established by objective, standardized laboratory measurements performed according to internationally recognized consensus standards (e.g., ASTM, ISO, EN). For biocompatibility, it's the biological response observed based on in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) assays against defined criteria.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI model, and therefore, it does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(91 days)
The 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 Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.
All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.
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 polyethylene.
The proposed device(s) 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 terylene and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
Based on the provided text, the device in question is a Surgical Mask, and the submission is a 510(k) premarket notification. This type of submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies for novel AI/ML-driven diagnostics.
Therefore, the requested information regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and standalone algorithm performance is not applicable to this document. This document describes the testing for physical and biological properties of the surgical masks to show they perform as well as a predicate device.
Here's the information that is applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the surgical masks are based on ASTM F2100 Level 2 requirements and other relevant standards.
| ITEM | Acceptance Criteria | Results (Blue Color) | Results (White Color) |
|---|---|---|---|
| Performance Characteristics (ASTM F2100 Level 2 Requirement) | |||
| Fluid Resistance (ASTM F1862) | 120 mmHg | 120 mmHg | 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) at 0.1 micron | ≥ 98% | ≥ 99.30% | ≥ 99.77% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | ≥ 98.54% | ≥ 99.04% |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mm H2O/cm² | < 5.4mm H2O/cm² | < 5.0mm H2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO 10993) | |||
| Cytotoxicity (ISO 10993-5) | No cytotoxicity effect | Under the conditions of the study, no cytotoxicity effect | Under the conditions of the study, no cytotoxicity effect |
| Irritation (ISO 10993-10) | No irritation effect | Under the conditions of the study, no irritation effect | Under the conditions of the study, no irritation effect |
| Sensitization (ISO 10993-10) | No sensitization effect | Under conditions of the study, no sensitization effect | Under conditions of the study, no sensitization effect |
The study proves the device meets the acceptance criteria as indicated by the "Results" columns. All reported values fall within or exceed the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The studies are non-clinical bench tests performed on the physical masks themselves (e.g., measuring filtration efficiency, pressure drop, flammability, and conducting biocompatibility tests).
The provenance of the data is from non-clinical bench testing performed on the devices manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. in China. The tests are reported as "Nonclinical Test Conclusion," implying they were conducted in a laboratory setting to verify the device's design specifications. The studies are prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This concept is not applicable to a submission for surgical masks based on physical and biological performance testing. "Ground truth" in this context refers to the results of standardized laboratory tests performed by qualified personnel using specified methodologies. There is no mention of expert consensus or human interpretation being part of establishing "ground truth" for these performance metrics.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results/labels. The tests are laboratory-based measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (surgical masks).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. Its performance is evaluated through physical and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance characteristics (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and biocompatibility testing (ISO 10993). These are objective, quantitative measurements against predefined criteria.
8. The Sample Size for the Training Set
Not applicable. This submission is for 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 this type of device.
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(87 days)
The 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 Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric. The Surgical Masks are single use, disposable device, provided non-sterile.
This document is a 510(k) Summary for a Surgical Mask, not an AI/ML medical device. Therefore, a significant portion of the requested information regarding AI/ML device acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.
The acceptance criteria and performance data provided in this document pertain to the physical and functional characteristics of the surgical mask, as tested against ASTM F2100-19 standards for medical face masks.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology (Test Standard) | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862M-17 | Fluid Resistance Performance | 29 out of 32 pass at 160mmHg | Pass at 160mmHg |
| ASTM F2299 | Particulate Filtration Efficiency | $\geq$ 98% | Pass |
| ASTM F2101-19 | Bacterial Filtration Efficiency | $\geq$ 98% | Pass |
| EN 14683:2019 Annex C | Differential Pressure | < 6.0mmH2O/cm² | Pass |
| 16 CFR 1610 | Flammability | Class I non-flammable | Pass |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for each test, but for Fluid Resistance (ASTM F1862M-17), the acceptance criterion mentions "29 out of 32 pass," indicating a test of at least 32 samples.
- Data Provenance: The tests were non-clinical performance tests conducted by the manufacturer, Hunan Triplex Precision Medical Devices Co., Ltd., based in Changsha, Hunan, China. The data would be considered prospective for the purpose of demonstrating compliance for this specific device.
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 product, not an AI/ML device relying on human expert annotations for ground truth. Testing involves laboratory measurements against established standards.
4. Adjudication method for the test set:
- None applicable. This is non-clinical laboratory testing, not a human reader study requiring adjudication. The results are quantitative measurements against predefined thresholds.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This 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 algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is defined by the established performance standards (e.g., ASTM F2100-19, EN 14683:2019, 16 CFR 1610) and the specific methodologies outlined within those standards for measuring characteristics like fluid resistance, filtration efficiency, differential pressure, and flammability.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
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(87 days)
The 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 Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Surgical Masks are manufactured with three/four layers. The surgical mask has two models which are SNN200640 and MN12. They are basically the same, the only difference is the SNN200640 has the three layers and MN112 has the fours layers. The Surgical Masks are single use, disposable device, provided non-sterile.
The document you provided is a 510(k) Premarket Notification for surgical masks, which focuses on demonstrating substantial equivalence to a predicate device. It includes non-clinical testing results against specific standards, but it does not describe a study in the context of evaluating an AI/ML-driven device's performance against clinical acceptance criteria. The questions you've asked are typically relevant for AI/ML medical devices.
Since the provided text describes a medical device (surgical masks) that is evaluated based on physical and filtration properties, and not an AI/ML device, many of the requested categories (like number of experts, ground truth, AI assistance effect size, training set) are not applicable.
However, I can extract the acceptance criteria and performance data for the surgical masks from the "Non-Clinical Testing" section.
Here's the information derived from the document, acknowledging that it's for a traditional medical device, not an AI/ML system:
1. A table of acceptance criteria and the reported device performance
| Standard | Purpose | Acceptance Criteria (Level 1) | Acceptance Criteria (Level 3) | Reported Performance |
|---|---|---|---|---|
| ASTM F1862M-17 | Fluid Resistance Performance | 29 out of 32 pass at 80mmHg | 29 out of 32 pass at 160mmHg | Pass |
| ASTM F2299 | Particulate Filtration Efficiency | ≥95% | ≥98% | Pass |
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥95% | ≥98% | Pass |
| EN 14683:2019 Annex C | Differential Pressure | <5.0mmH2O/cm² | <6.0mmH2O/cm² | Pass |
| 16 CFR 1610 | Flammability | Class I non flammable | N/A | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Fluid Resistance (ASTM F1862M-17), the acceptance criterion mentions "29 out of 32 pass", implying a sample size of 32 items tested for this specific criterion.
- For other tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the document states "Pass" without specifying the exact number of units tested.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are standard non-clinical tests performed in a lab setting rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a surgical mask, and its performance is evaluated against standardized test methods for physical properties (like filtration efficiency and fluid resistance), not against expert interpretations of clinical images or data. Ground truth in this context is established by the methods outlined in standards such as ASTM F1862M-17, ASTM F2299, ASTM F2101-19, EN 14683:2019, and 16 CFR 1610.
4. Adjudication method for the test set
This question is not applicable. The performance is measured directly by scientific instruments and defined protocols within the specified ASTM and EN standards, not through human adjudication or consensus.
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 question is not applicable as the device is a surgical mask and not an AI-assisted diagnostic or interpretive system. No human reader studies with or without AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a surgical mask and does not involve any algorithm or AI component performing in a standalone capacity.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these surgical masks is established by physical and material testing standards (e.g., filtration rates, fluid resistance under specified pressures, flammability class) as defined by organizations like ASTM and EN.
8. The sample size for the training set
This question is not applicable. The document describes non-clinical performance testing for a physical product, not the development of an AI/ML model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
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(86 days)
The 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 non-sterile.
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. 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 size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.
This document describes the performance testing for the Bain Medical Equipment (Guangzhou) Co., Ltd. Surgical Masks (K203524).
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test / Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M-17) | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (ASTM F2101-2019) | To determine the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of Staphylococcus aureus. | ≥98% | Average 99.9% |
| Particulate Filtration Efficiency (ASTM F2299/F2299M-03 (2017)) | To determine the Particle Filtration Efficiency of materials used in medical face masks to penetration by particulates using latex spheres. | ≥98% | Average 98.8% |
| Differential Pressure (EN 14683:2019) | To determine the differential pressure. | <6.0 mm H2O/cm² | Average 4.5 mm H2O/cm² |
| Flammability (16 CFR 1610) | To evaluate the flammability of the test sample. | Class I | Class I |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for each test. However, it indicates that the tests were performed in accordance with recognized international standards (ASTM, EN, CFR), which typically specify sample sizes for such evaluations. The data provenance is from non-clinical testing conducted by Bain Medical Equipment (Guangzhou) Co., Ltd., as part of their 510(k) submission to the FDA. The country of origin for the data is implicitly China, where Bain Medical Equipment (Guangzhou) Co., Ltd. is located. It is retrospective in the sense that the testing was performed and the results are being reported for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This report details non-clinical laboratory performance testing of a medical device (surgical masks), not a diagnostic or AI-based device requiring human expert consensus for ground truth. The "ground truth" for these tests is established by the specified methodology and measurement against the defined acceptance criteria in the respective standards.
4. Adjudication Method for the Test Set
Not applicable, as this is laboratory performance testing against established standards, not a clinical study involving human assessment or adjudication of outcomes.
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 submission is for a medical device (surgical masks) which is evaluated through non-clinical performance testing against established standards, not through clinical comparative effectiveness studies with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective measurements and defined acceptance criteria outlined in specific industry standards and regulations (e.g., ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610). These standards dictate the methodology and expected outcomes for each performance characteristic of a surgical mask.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/machine learning device.
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(102 days)
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description.
All of the proposed devices are non-sterile, and only for single use.
This medical device is a surgical mask and the "study" referred to is a series of bench tests to demonstrate compliance with various standards, not a clinical study involving human participants or AI. Therefore, most of the requested information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, AI improvement effect size, standalone performance, ground truth types) is not applicable in this context.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by various standards for mask performance. The reported device performance is that the proposed device complies with these standards.
| Performance Metric | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Performance | ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks | Complies |
| Fluid Resistance | ASTM F 1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | Complies |
| Bacterial Filtration Efficiency (BFE) | EN 14683: 2005 Surgical masks, Requirements and test methods. | Complies |
| Particulate Filtration Efficiency (PFE) | ASTM F 2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Complies |
| Flammability | 16 CFR 1610, Standard for the Flammability of Clothing Textiles; Corrections | Complies |
| Differential Pressure (Delta-P) | Mil M36954C Military Specification- Mask, Surgical, Disposable | Complies |
| Biocompatibility | - ISO 10993-5:2009 "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity."- ISO 10993-10:2002 Standard, "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity"- ISO 10993-10:2002 Standard and Amendment 1, 2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT I" | Complies |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the conventional sense for a clinical study. Instead, these are bench tests conducted to verify the device met design specifications. The data provenance is not explicitly stated as retrospective or prospective, but as bench tests, they are inherently prospective in their execution for the purpose of the 510(k) submission. The country of origin for the testing itself is not stated, but the manufacturer is based in Shanghai, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these types of engineering and performance tests is defined by the objective measurement criteria within the specified standards, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is used for these objective performance 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 is a surgical mask, not an AI-powered diagnostic device. No human-in-the-loop performance or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device (surgical mask), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective physical and chemical properties and performance characteristics as measured against the specifications outlined in the referenced ASTM, EN, 16 CFR, Mil M, and ISO standards.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment.
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