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510(k) Data Aggregation
(220 days)
The single-use medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided sterile and 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 spunbonded 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 held in place over the users' mouth and nose by ear loops/ ties welded to the mask. The nose clip is made of polypropylene and iron. 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. Both the ear loop and tie-on masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-19, which are provided in following table. The difference of the level 1, level 2 and level 3 masks is the gram weight of the melt-blown nonwoven. The gram weight of the melt-blown nonwoven for level 1 is 30g/m², and that for level 2 and level 3 masks is 40g/m². Level 2 and level 3 masks are exactly the same and are divided into level 2 and level 3 just for marking. The proposed devices are provided in sterile and non-sterile two types.
This document describes the premarket notification (510(k)) for a Single-use Medical Face Mask, not an AI/ML medical device. Therefore, the information requested in points 2-9 of your prompt (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of the physical medical face mask against established industry standards.
However, I can extract information related to the acceptance criteria and the study proving the device meets these criteria as presented in the document for the physical medical face mask.
Here's the table of acceptance criteria and reported device performance based on the provided text, focusing on the non-clinical tests:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance (Test Result) |
|---|---|---|
| Resistance to Penetrationby Synthetic blood (ASTM F1862/F1862M-17) | Level 1: No penetration at 80 mmHg;Level 2: No penetration at 120 mmHg;Level 3: No penetration at 160 mmHg | Sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgSterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgNon-sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgNon-sterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-2019) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-on: Level 1: 98.48%; Level 2: 99.84%; Level 3: 99.85%Sterile Ear loop: Level 1: 98.38%; Level 2: 99.86%; Level 3: 99.89%Non-sterile Tie-on: Level 1: 98.39%; Level 2: 99.82%; Level 3: 99.87%Non-sterile Ear loop: Level 1: 98.67%; Level 2: 99.86%; Level 3: 99.88% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-on: Level 1: 99.22%; Level 2: 99.85%; Level 3: 99.88%Sterile Ear loop: Level 1: 99.23%; Level 2: 99.86%; Level 3: 99.88%Non-sterile Tie-on: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.88%Non-sterile Ear loop: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.87% |
| Differential Pressure (EN 14683:2019) | Level 1: <5.0 mm H2O/cm²Level 2: <6.0 mm H2O/cm²Level 3: <6.0 mm H2O/cm² | Sterile Tie-on: Level 1: 4.00 mm H2O/cm²; Level 2: 4.83 mm H2O/cm²; Level 3: 4.90 mm H2O/cm²Sterile Ear loop: Level 1: 3.83 mm H2O/cm²; Level 2: 4.77 mm H2O/cm²; Level 3: 4.90 mm H2O/cm²Non-sterile Tie-on: Level 1: 4.10 mm H2O/cm²; Level 2: 4.90 mm H2O/cm²; Level 3: 4.93 mm H2O/cm²Non-sterile Ear loop: Level 1: 4.00 mm H2O/cm²; Level 2: 4.90 mm H2O/cm²; Level 3: 4.97 mm H2O/cm² |
| Flammability (16 CFR 1610) | Class I | Class I (for all levels) |
| EO ECH Residual Test (ISO 10993-7:2008) | EO residual shall not exceed 4mg/deviceECH residual shall not exceed 9mg/device | EO residual was less than 4mg/deviceECH residual was less than 9mg/device |
| Cytotoxicity (ISO 10993-5: 2009) | The viability should be >70% of the blank.And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.Under the conditions of the study, the proposed device was non-cytotoxic. |
| Irritation (ISO 10993-10: 2010) | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
| Sensitization (ISO 10993-10: 2010) | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
Study Details (Relevant to medical device testing, not AI/ML performance)
1. Sample sized used for the test set and the data provenance:
- Sample Size: The document specifies that tests for Resistance to Penetration by Synthetic Blood, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, and Differential Pressure were conducted "from 3 non-consecutive lots." This indicates that at least one sample from each of three different manufacturing lots was tested for these parameters. The exact number of samples per lot is not specified.
- Data Provenance: The tests were non-clinical tests conducted by the manufacturer, Jiangxi Hongda Medical Equipment Group Co., Ltd., based in China, for submission to the U.S. FDA. The document does not specify a country of origin for the data (e.g., patient data), as these are material performance tests, not clinical performance tests. The data is retrospective in the sense that it was collected prior to this submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable for this type of medical device submission. The "ground truth" for a medical face mask's performance is established by standardized test methods (e.g., ASTM, EN, ISO standards) and material properties, not by expert consensus or interpretations of medical images. The tests measure objective physical and biological properties.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving expert interpretation of data (e.g., medical images) where there can be inter-reader variability. For the physical and material performance tests of a face mask, the results are quantitative and objective, based on standardized testing procedures.
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:
- This information is not applicable. This document is for a physical medical device (face mask), not an AI/ML medical device. Therefore, no MRMC comparative effectiveness studies involving human readers and AI assistance were conducted or are relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective measurements from standardized non-clinical laboratory tests according to recognized consensus standards (ASTM, EN, ISO). For example, Bacterial Filtration Efficiency has a specific test method that yields a quantitative percentage. There is no subjective interpretation or clinical outcomes data used to establish "ground truth" for these performance characteristics.
7. The sample size for the training set:
- This information is not applicable. Since this is a physical medical device (face mask) and not an AI/ML device, there is no "training set" in the context of machine learning. The device production involves manufacturing processes, and testing is performed on samples from production lots.
8. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 7.
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(162 days)
The Single-use medical face mask is intended to be worn to protect 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 nonsterile.
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the FDA 510(k) clearance for a "Single-use medical face mask" (Model: HD0969). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for medical face masks.
| Test Methodology | Purpose | Acceptance Criteria for Level 3 | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|---|---|
| Fluid Resistance Performance (mmHg) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS (Average of 3 batch numbers: 160mmHg) | Yes |
| Particulate Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 98.79%) | Yes |
| Bacterial Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 99.87%) | Yes |
| Differential Pressure (mmH2O/cm²) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | <6.0 mmH2O/cm² | PASS (Average of 3 batch numbers: 4.7 mmH2O/cm²) | Yes |
| Flammability Class | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Class 1 | PASS (Class 1) | Yes |
Biocompatibility Testing:
| Test Item | Acceptance Criteria (Implied by PASS result) | Reported Device Performance (Result) | Meets Criteria? |
|---|---|---|---|
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Yes |
| Irritation | Non-irritating | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Yes |
| Sensitization | Non-sensitizing | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For the Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure tests, the reported results are "Average of 3 batch numbers." This implies testing was performed on samples from at least 3 distinct batches. The exact number of samples per batch or per test is not specified, but the methodology typically involves testing multiple samples to derive an average.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the applicant is "Zhuhai Herald Datanetics Limited." in China, and the correspondent is "Share Info (Guangzhou) Medical Consultant Ltd." also in China, suggesting the testing was likely conducted in China or by labs affiliated with the manufacturer. The tests are based on recognized international standards (ASTM, MIL, ISO), which ensures consistency in methodology. The data is retrospective for the purpose of this 510(k) submission, as it represents tests conducted prior to the submission.
3. Number of Experts and their Qualifications for Ground Truth
- Not Applicable: This submission is for a medical face mask, a physical device, and its performance is evaluated against established, quantitative engineering and biological standards (e.g., filtration efficiency, fluid resistance, biocompatibility). It does not involve interpretation of complex data (like medical images) by human experts to establish "ground truth." Therefore, there is no team of experts establishing ground truth in the way it would be for an AI/ML diagnostic device. The ground truth is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set
- Not Applicable: As the test methods are objective, quantitative measurements against international standards for a physical device, there is no need for expert adjudication of results. The results are Pass/Fail based on the measured values compared to the defined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for AI-driven diagnostic or assistive devices, not for physical medical devices like face masks. The performance evaluation here is based on the intrinsic physical and biological properties of the mask.
6. Standalone (Algorithm Only) Performance
- Not Applicable: This is not an AI/ML algorithm. The performance described is inherent to the physical characteristics of the manufactured face mask.
7. Type of Ground Truth Used
- The ground truth for the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) is defined by objective, quantitative measurements against established international consensus standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610 (Class 1)).
- For biocompatibility, the ground truth is established by biological test results (Cytotoxicity, Irritation, Sensitization) conforming to the principles outlined in ISO 10993-1:2018.
8. Sample Size for the Training Set
- Not Applicable: This device is a physical product, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.
In summary, the substantial equivalence of the "Single-use medical face mask" (Model: HD0969) was demonstrated through a series of non-clinical, objective performance tests designed to verify compliance with the ASTM F2100 Level 3 standard and biocompatibility requirements. The study does not involve human interpretation or AI algorithms, thus many of the questions related to those types of studies are not applicable.
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(206 days)
The Single-use Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use. The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.
This is a 510(k) premarket notification for a medical device (Single-use Medical Face Mask), not an AI/ML-enabled device. Therefore, many of the requested categories for AI/ML study design and performance evaluation are not applicable.
However, I can extract the acceptance criteria and performance data for the medical face mask as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Level 2 ASTM F2100) | Reported Device Performance (Average for 3 lots) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.77% |
| Sub-Micron Particle Filtration Efficiency | ≥ 98% | 99.80% |
| Differential Pressure, mm H2O/cm² | < 6.0 mm H₂O/cm² | 4.01 mmH2O/cm² |
| Flammability | Class 1 | Class 1 (Non-Flammable) |
| Resistance to Penetration by Synthetic Blood | Pass at 120 mmHg | Pass at 120 mmHg |
| Cytotoxicity | Pass (Not cytotoxic) | Pass |
| Sensitization | Pass (Not a sensitizer) | Pass |
| Skin Irritation | Pass (Not an irritant) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Flammability, BFE, Differential Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by Synthetic Blood), the study used 3 non-consecutive lots, with 32 samples per lot. The total number of samples tested for each of these performance criteria is 96 (3 lots x 32 samples/lot).
- Data Provenance: The document does not specify the country of origin of the data providers or if the data was retrospective or prospective, as these are not typically relevant for the physical performance testing of a medical mask. This information is usually provided by the manufacturer based on their internal testing protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This is a medical device (face mask) with physical performance criteria, not an AI/ML-enabled device where expert human ground truth is established for image interpretation or diagnosis. The "ground truth" is determined by objective laboratory testing against established standards (ASTM F2100).
4. Adjudication Method for the Test Set
- Not applicable. As described above, the "ground truth" is determined by objective laboratory measurements against predefined thresholds, not by human expert consensus or 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
- Not applicable. This is a medical device (face mask), not an AI/ML-enabled device requiring a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (face mask) with physical performance, not an AI/ML algorithm. The "standalone performance" is the direct physical testing of the mask's material properties.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is established by objective laboratory measurements against recognized international standards and specifications (primarily ASTM F2100-19 and 16 CFR 1610 for flammability), as well as biocompatibility testing standards for cytotoxicity, irritation, and sensitization. These standards define the acceptable range or threshold for each performance characteristic.
8. The Sample Size for the Training Set
- Not applicable. This is a manufactured medical device, not an AI/ML model that requires a training set of data. The manufacturing process involves quality control and testing, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
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(235 days)
Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Methods | Reported Device Performance | Acceptance Criteria |
|---|---|---|---|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19 / ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron (%) | ASTM F2100-19 / ASTM F2299 / ASTM F2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19 / ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-19 / 16 CFR Part 1610-2019 | NA (result implicit Class 1) | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19 / EN 14683:2019+AC:2019(E) Annex C | Average 2.44 | Level 1: <5.0 |
| Cytotoxicity (ISO 10993-5) | ISO 10993-5: 2009 | Non-cytotoxic | Non-cytotoxic |
| Sensitization (ISO 10993-10) | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing |
| Irritation (ISO 10993-10) | ISO 10993-10:2010 | Non-irritating | Non-irritating |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each performance test. It only mentions that "Performance testing was conducted on the single-use medical face mask." The data provenance is North America (as per ASTM standards), but the manufacturing country is China. The study is a non-clinical, retrospective study based on laboratory testing of the device.
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's performance is established through standardized laboratory testing (e.g., ASTM standards) rather than expert consensus on images or clinical cases. The "experts" would be the certified laboratories performing these specific biomechanical/material tests, adhering to the outlined standards. Their qualifications are inherent in their accreditation to perform such tests.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring 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
Not applicable. This is a medical face mask, not an AI-powered diagnostic device. No human reader or AI comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (face mask), not an algorithm.
7. The type of ground truth used
The ground truth used is based on standardized test methods and predefined quantitative acceptance criteria from regulatory and industry standards such as ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, EN 14683:2019+AC:2019(E) Annex C, and ISO 10993 for biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring 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 medical device.
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