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510(k) Data Aggregation
(57 days)
The Medical 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 a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Average Result) | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 120 mmHg for Level 2 | Level 2: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested) | PASS |
| (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | Level 3: 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested) | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Level 2: 99.2% (3 non-consecutive lots tested) | PASS |
| (ASTM F2299) | Level 3: 99.5% (3 non-consecutive lots tested) | PASS | |
| Bacterial Filtration Efficiency | ≥ 98% | Level 2: 99.3% (3 non-consecutive lots tested) | PASS |
| (ASTM F2101) | Level 3: 99.3% (3 non-consecutive lots tested) | PASS | |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Level 2: 5.0 mmH2O/cm² (3 non-consecutive lots tested) | PASS |
| (EN 14683 Annex C) | Level 3: 4.4 mmH2O/cm² (3 non-consecutive lots tested) | PASS | |
| Flammability | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested) | PASS |
| (16 CFR 1610) | Level 3: Class 1 (3 non-consecutive lots tested) | PASS | |
| Biocompatibility - Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance Performance (ASTM F1862): 32 samples per lot, tested across 3 non-consecutive lots.
- Particulate Filtration Efficiency (ASTM F2299): 32 samples per lot, tested across 3 non-consecutive lots.
- Bacterial Filtration Efficiency (ASTM F2101): 32 samples per lot, tested across 3 non-consecutive lots.
- Differential Pressure (EN 14683 Annex C): 32 samples per lot, tested across 3 non-consecutive lots.
- Flammability (16 CFR 1610): 32 samples per lot, tested across 3 non-consecutive lots.
- Biocompatibility (ISO 10993-5, ISO 10993-10): The document does not specify the exact sample size for biocompatibility testing, but it was conducted on the mask materials (nose clip and ear loops components were specifically mentioned).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they were "non-clinical tests conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The tests performed are objective performance tests on the medical device itself (face mask), not assessments requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are objective laboratory performance tests with defined pass/fail criteria, 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:
- No MRMC comparative effectiveness study was done. This medical device is a face mask, and the submission focuses on its physical and biological performance characteristics, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a medical face mask, not an algorithm or software. All performance tests are on the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established scientific and regulatory standards (e.g., ASTM F2100-19, EN 14683, ISO 10993). Compliance is determined by objective measurements against these standards.
8. The sample size for the training set:
- This information is not applicable. This is a medical face mask, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons mentioned above.
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(57 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001) is available in white, blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Medical Face Mask (Model: M001). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K211631) through non-clinical performance testing and biocompatibility assessments, rather than AI/ML algorithm performance.
Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training sets, etc.) are not applicable to this submission, as it pertains to a physical medical device (face mask) and not an AI-powered diagnostic or assistive technology.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose (Test) | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure. | Level 2: 29 out of 32 pass at 120 mmHg Level 3: 29 out of 32 pass at 160 mmHg | Level 2: 32 out of 32 per lot pass at 120 mmHg for 3 non-consecutive lots tested Level 3: 32 out of 32 per lot pass at 160 mmHg for 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron. | ≥ 98% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism. | ≥ 98% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask. | < 6.0 mmH2O/cm² | Level 2: 4.4 mmH2O/cm² (3 non-consecutive lots tested, sample size 32/lot) Level 3: 5.1 mmH2O/cm² (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Flammability 16 CFR 1610 | Assess the resistance of a mask to ignition. | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested, sample size 32/lot) Level 3: Class 1 (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Biocompatibility - Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Assess the potential risk of Irritation of mask material. | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Assess the potential risk of Sensitization of mask material. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for performance testing: For each performance test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), 3 non-consecutive lots were tested, with a sample size of 32 units per lot.
- Data Provenance: The tests were conducted to verify the device's compliance with standards and requirements, implying the data originates from prospective testing specifically performed for this submission. The manufacturer is Xingyu Medical Tech Co., Ltd. located in China.
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 device (mask), not an AI/ML algorithm where expert ground truth is typically assessed for image interpretation or diagnosis. The "ground truth" for the mask is based on objective measurements against established technical standards (e.g., ASTM, EN, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is for a physical device, not an AI/ML diagnostic or assistive technology. Test results are objective measurements based on 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
- No. This is a physical medical device (face mask). MRMC studies are relevant for AI/ML diagnostic or assistive technologies that interact with human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. Standalone algorithm performance studies are relevant for AI/ML diagnostic or assistive technologies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical face masks (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). Performance is determined by meeting objective quantitative and qualitative criteria defined in these standards.
8. The 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 above, no training set or AI/ML ground truth establishment is involved.
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(122 days)
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(71 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Malleable polyethylene wire.
The medical face masks are available in five sizes, 17.59.5cm, 15.59.5cm, 14.59.5cm, 149.5cm.
The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text is related to the FDA 510(k) clearance for a Medical Face Mask. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than focusing on AI/ML-driven device performance. Therefore, many of the requested elements for describing an AI-powered device's acceptance criteria and study cannot be directly extracted from this document, as they are not applicable to the type of device (medical face mask) being discussed.
However, I can extract the acceptance criteria and performance data relevant to this medical face mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass (32 out of 32 pass at 80 mmHg, 3 lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate functionality | $\ge$ 95% | Pass (> 95%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate functionality | $\ge$ 95% | Pass (> 99%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate functionality | < 5.0 mmH₂O/cm² | Pass (< 4.0 mmH₂O/cm²) |
| Flammability (16 CFR 1610) | Demonstrate functionality | Class 1 | Pass (Class 1) |
| Cytotoxicity (ISO 10993-5) | Demonstrate safety | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Demonstrate safety | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Demonstrate safety | Non-sensitizing | Non-sensitizing |
Since this is a submission for a medical face mask and not an AI/ML device, the following points are not applicable or cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: The document mentions "3 non-consecutive lots" for fluid resistance testing but doesn't specify an overall sample size for the various performance tests. Data provenance in terms of country of origin or retrospective/prospective is not specified as these are material performance tests, not clinical data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a face mask is established by validated laboratory testing against standards, not by expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for expert review of complex data, not physical product testing.
- 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-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is established through adherence to recognized international and national standards for medical face masks, such as ASTM F2100, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable.
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(316 days)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
The provided text describes the regulatory clearance for a Medical Face Mask (K210679) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device (K200847). This is a submission for a physical medical device, not an AI/ML-driven device, so many of the requested elements for AI/ML studies are not applicable.
Here's a breakdown of the information that is available and a note on the missing information, tailored to the AI/ML context of your request:
Acceptance Criteria and Reported Device Performance
The device is a medical face mask, and its performance is evaluated against established standards for materials used in such masks.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (K2106679) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood. | 29 Out of 32 pass at 120 mmHg | Lot 1: 32 Out of 32 pass at 120 mmHgLot 2: 32 Out of 32 pass at 120 mmHgLot 3: 32 Out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Measure initial particulate filtration efficiency using monodispersed aerosols (0.1µm latex spheres). | ≥ 98% | Lot 1: 98.9%Lot 2: 98.9%Lot 3: 98.7% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Determine bacterial filtration efficiency using a biological aerosol of Staphylococcus Aureus. | ≥ 98% | Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | Pass |
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Measure differential pressure between the inside and outside of the mask. | < 6.0 mmH2O/cm² | Lot 1: 3.0 mmH2O/cm²Lot 2: 3.1 mmH2O/cm²Lot 3: 3.3 mmH2O/cm² | Pass |
| Cytotoxicity (ISO 10993-5) | Determine biological reactivity of mammalian cell culture (mouse fibroblast L929cells). | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Evaluate potential skin irritation from extract on rabbit skin. | Non-irritating | Non-Irritating | Pass |
| Sensitization (ISO 10993-10) | Evaluate potential for extracts to cause skin sensitization in guinea pig. | Non-sensitizing | Non-sensitizing | Pass |
Information Relevant to AI/ML Studies (and why it's mostly absent):
This document describes the regulatory clearance for a physical medical face mask, not an AI/ML powered device. Therefore, information points 2 through 9, which are specifically relevant to the evaluation of AI/ML algorithms, are not applicable and are consequently missing from this submission.
- Sample size used for the test set and data provenance: Not applicable. Performance is evaluated on physical samples/lots of the mask material against defined standards. The data provenance is laboratory testing conducted according to specified ASTM, CFR, EN, and ISO standards. The country of origin of the device manufacturer is China.
- Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for the physical properties of the mask (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory testing methods, not by expert consensus readings of medical images.
- Adjudication method for the test set: Not applicable. Performance is measured objectively through lab tests.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study involves human readers interpreting medical images, optionally with AI assistance. The device is a physical mask.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable. There is no algorithm.
- Type of ground truth used: Ground truth is defined by the objective measurements and pass/fail criteria outlined in the relevant ASTM, CFR, EN, and ISO standards for physical properties and biocompatibility.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document details the testing and acceptance criteria for a physical medical device (face mask). It successfully demonstrates that the device meets the specified performance criteria through a series of standardized laboratory tests for filtration, fluid resistance, flammability, breathability, and biocompatibility. The framework of questions you've provided is designed for AI/ML devices, hence much of the requested information (e.g., expert readers, adjudication, training data) is not present in this submission.
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(119 days)
The medical face masks are intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users can adjust the nose clip 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 proposed devices are provided in non-sterile.
This document is a 510(k) summary for a Medical Face Mask (K212994) by Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. It compares the proposed device to a predicate device (K160269) to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical performance characteristics evaluated, their acceptance criteria, and the reported results for the proposed device (Level 3 mask, as Level 1, 2, and 3 are physically the same) are presented in the following table:
| Performance Characteristics | Test Method | Reported Device Performance | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862/F1862M: 2017 | Pass at 160 mmHg | No penetration at 160 mmHg | Meet the requirement |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 (2017) | Pass at 99.2% | ≥98% | Meet the requirement |
| Bacterial Filtration Efficiency | ASTM F2101: 2019 | Pass at 99.2% | ≥98% | Meet the requirement |
| Differential Pressure (Delta-P) | EN 14683: 2019, Annex C | Pass at 3.8 mm H2O/cm² | <6.0 mmH2O/cm² | Meet the requirement |
| Flammability class | 16 CFR Part 1610 | Class 1 | Class 1 | Meet the requirement |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Meet the requirement |
| Biocompatibility (Sensitization) | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing | Meet the requirement |
| Biocompatibility (Irritation) | ISO 10993-10:2010 | Non-irritating | Non-irritating | Meet the requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test. However, it indicates that the tests were conducted on the "proposed device" which is a "Medical Face Mask." The provenance of the data is not explicitly stated as country of origin, but the submission is from Guangzhou Quantum Laser Intelligent Equipment Co., Ltd., China. The tests are non-clinical (laboratory-based performance tests) and are inherently retrospective in the sense that they are conducted on finished products for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. These are non-clinical performance tests, not studies requiring expert interpretation of clinical data. The "ground truth" for these tests is defined by the standardized test methods (e.g., ASTM, EN, ISO standards) themselves, which specify objective measurements and criteria.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective, standardized non-clinical tests, not subjective assessments requiring adjudication.
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 document is for the clearance of a medical device (face mask) based on non-clinical performance tests and substantial equivalence to a predicate device, not for evaluating the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone non-clinical performance testing was done for the device. The results reported in the table (e.g., fluid resistance, filtration efficiency, differential pressure, flammability, biocompatibility) are all based on the performance of the device itself, without any human-in-the-loop component for evaluating its primary function.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on established industry standards and regulatory requirements. For example:
- Fluid Resistance: No penetration at 160 mmHg, as per ASTM F1862/F1862M.
- Particulate/Bacterial Filtration Efficiency: ≥98%, as per relevant ASTM standards (F2299/F2101) and ASTM F2100.
- Differential Pressure: <6.0 mmH2O/cm², as per EN 14683 Annex C and ASTM F2100.
- Flammability: Class 1, as per 16 CFR Part 1610.
- Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, as per ISO 10993-5 and ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (face mask) submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML algorithm, there is no training set and therefore no ground truth establishment for a training set.
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(204 days)
The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
Here's a breakdown of the acceptance criteria and study information for the "MEDICAL FACE MASKS, Model Name: MY020003" based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Tests: | |||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | 32 pass / 32 tested Accepted |
| Particulate Filtration Efficiency (PFE) | ASTM F2299-03 (2017) | ≥98% | 32 pass / 32 tested Accepted |
| Differential Pressure (ΔP) | EN 14683:2019+AC (2019)(E), Annex C | <6.0 mm H₂O/cm² | 32 pass / 32 tested Accepted |
| Synthetic Blood Penetration Resistance | ASTM F1862M-17 | 120 mmHg | 32 pass / 32 tested Accepted |
| Flammability | 16 CFR Part 1610 (As Amendment In 2008) | (A) There are no burn times; or(B) There is only one burn time and it is equal to or greater than 3.5 seconds; or(C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. | Class 1 (indicating it meets the criteria for low flammability) |
| Biocompatibility Tests: | |||
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Cell viability reduced to <70% of the blank indicates cytotoxic potential. The 50% extract of the test article should have at least the same or a higher viability than the 100% extract. | Under the conditions of the test, the test article was found to be non-cytotoxic. |
| Skin Sensitization | ISO 10993-10:2010 | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. | Under the conditions of the test, the test article was found to be non-sensitizing. |
| Skin Irritation | ISO 10993-10:2010 (using New Zealand white Rabbits) | Calculated based on erythema and edema grades at 24h, 48h, and 72h observations. | Under the conditions of the test, the test article was found to be non-irritating (implied, as it states "non-" and the criteria leads to this conclusion. The table cuts off the full result, but based on the overall conclusion, it passed). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Performance Tests: For BFE, PFE, Differential Pressure, and Synthetic Blood Penetration Resistance, the reported sample size is 32 samples (indicated by "32pass/32tested"). For Flammability, the number of specimens is not explicitly stated but implied to be sufficient for 16 CFR Part 1610 testing (which typically involves multiple specimens).
- Sample Size for Biocompatibility Tests: The documentation does not specify the exact number of L-929 cells for cytotoxicity, guinea pigs for skin sensitization, or New Zealand white Rabbits for skin irritation. It describes the test methods from the ISO standards, which define typical sample sizes.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a Chinese manufacturer (Huizhou Jie Bai Purification Co.,Ltd. in Huizhou, Guangdong, China), it can be inferred that the testing was likely conducted in China, often by contract research organizations (CROs) that adhere to international standards. These tests are part of a regulatory submission, so they are inherently prospective for the purpose of demonstrating device safety and effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this type of device and study. The "Medical Face Masks" is a physical product, and its performance and biocompatibility are evaluated through standardized laboratory tests (e.g., ASTM, EN, ISO standards), not through expert consensus on diagnostic interpretations. The "ground truth" for these tests is the objective measurement of physical and biological properties against defined standards.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) where an agreement between multiple readers is required to establish a ground truth when a definitive external standard (like pathology) is unavailable. For medical device performance testing, the results are objectively measured according to the specified test methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission details the performance and biocompatibility of a medical face mask, which is a physical barrier device. It does not involve any AI components, human readers, or diagnostic interpretation, therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated, the device is a medical face mask, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance and biocompatibility of this device is established by objective measurements and observations against pre-defined scientific and regulatory standards. For example:
- Performance: Measured values (e.g., BFE %, PFE %, ΔP, blood penetration resistance) are compared directly to the numerical acceptance criteria specified in the ASTM and EN standards. Flammability is observed and categorized based on burn times.
- Biocompatibility: Cell viability, skin reactions (erythema, edema), and sensitization responses are observed and categorized according to the methodologies and criteria outlined in the ISO 10993 standards and then compared to the acceptance criteria to determine "non-cytotoxic," "non-sensitizing," and "non-irritating."
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm or a trainable system. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable because there is no training set.
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(90 days)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.
This document describes the premarket notification (510(k)) for a Medical Face Mask, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is for a physical medical device (a face mask) and not an AI/ML-driven device. Therefore, many of the requested details about AI model performance, training sets, ground truth establishment by experts, adjudication, and MRMC studies are not applicable to this document.
However, I can extract and present the acceptance criteria and the study results for this specific medical device.
Device: Medical Face Mask (K212471)
Predicate Device: Surgical Face Masks (Ear loops and Tie-on) (K160269)
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are "Pass" for all tests, with specific quantitative thresholds where applicable. The reported device performance is that all tests met these criteria.
| Item | Test Methods | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Flammability | ASTM F2100-19, 16 CFR Part 1610-2008 | Class 1 | Pass |
| Bacterial Filtration Efficiency (BFE) | ASTM F2100-2019 9.1, ASTM F2101-2019 | ≥95% | Pass |
| Differential Pressure | ASTM F2100-19 9.2 | < 5.0 mm H₂O/cm² | Pass |
| Sub-Micron Particle Filtration Efficiency | ASTM F2100-2019 9.3, ASTM F2299/F2299M-2017 | ≥95% | Pass |
| Resistance to Penetration by Synthetic Blood | ASTM F2100-2019 9.4, ASTM F1862/F1862-2017 | Pass at 80 mmHg | Pass |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5: 2009 | Non-cytotoxic | Non-cytotoxic |
| Sensitization | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing |
| Skin Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of masks) used for each specific performance or biocompatibility test. It mentions that "All of the tested parameters met the predefined acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance.
The data provenance is implied to be from testing conducted by Haian Medigauze Co., Ltd. in China, as they are the submitter. The data is retrospective, as it's being submitted for premarket notification of a completed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as this is a physical medical device (face mask) and not an AI/ML-driven device that requires expert ground truth for its performance evaluation (e.g., image interpretation). The "ground truth" for the face mask is established by validated laboratory test methods and established international standards (ASTM, ISO).
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Performance is determined by objective, measurable laboratory tests, not by human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This question is not applicable as this is not an AI-assisted diagnostic device or a device where human reader performance is a relevant metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as this is not an AI/ML algorithm. The "standalone" performance refers to the intrinsic physical properties and filtration capabilities of the face mask itself, as measured by standard laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective laboratory measurements against predefined performance standards (e.g., ASTM F2100-19 for filtration efficiency, differential pressure, flammability, and resistance to synthetic blood penetration; ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for this type of device.
8. The Sample Size for the Training Set
This question is not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" process with a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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(100 days)
The Disposable Medical Face Mask (Model:LT0819, Ear loops) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the acceptance criteria and performance of the "Disposable Medical Face Mask (Model:LT0819, Ear loops)" manufactured by Shenzhen Lyttop Healthcare Limited. The device is classified as a Class II surgical apparel (21 CFR 878.4040) with product code FXX.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing to demonstrate its performance against recognized standards, specifically for Level 2 medical masks according to ASTM F2100.
| Test Methodology | Purpose | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 Pass at 120 mmHg | 3 lots, 32 out of 32 passes at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | 98.69%; 99.43%; 99.41% (for three lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | 99.89%; 99.9%; 99.9% (for three lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | To demonstrate the functionality of the subject device. | < 6.0 mmH₂O/cm² | 2.9 mm H₂O/cm²; 3.3 mm H₂O/cm²; 3.3 mm H₂O/cm² (for three lots) |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | Class 1; Class 1; Class 1 (for three lots) |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | To demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Biocompatibility - Irritation (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Biocompatibility - Sensitization (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that for performance testing, "3 lots" of the device were tested. For Fluid Resistance, 32 samples from each lot were tested (e.g., "32 out of 32 passes"). The specific sample sizes for other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are not explicitly stated as individual sample counts but are reported as percentages or numerical values per lot.
The data provenance is from non-clinical tests conducted to verify the device's performance against established standards. The country of origin for the testing data is not explicitly stated, but the manufacturer is Shenzhen Lyttop Healthcare Limited, China. The testing is retrospective in the sense that it's conducted on manufactured product samples to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device (face mask), not an AI or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective physical and biological test standards (e.g., specific filtration percentages, pressure differentials, and toxicity levels).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. The evaluation is based on direct measurement against predefined scientific and engineering criteria, not subjective expert judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or AI devices in assisting human readers, which is not the nature of a disposable medical face mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm-only" performance study was not done. The device is a physical medical face mask, not a software algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" used is based on objective, quantitative measurements against established national and international standards.
- Performance (Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability): The ground truth is defined by the specific thresholds and methodologies outlined in standards such as ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, and 16 CFR 1610. These standards provide clear, measurable criteria for acceptable performance.
- Biocompatibility: The ground truth is defined by the biological response observed in standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests following ISO 10993 guidelines, where "non-cytotoxic," "non-irritating," and "non-sensitizing" are the accepted outcomes.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (a face mask) and does not involve an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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(82 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex and polyester fiber. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) summary for a Medical Face Mask, indicating it's a submission for clearance rather than a detailed study report. Therefore, information related to AI or clinical studies (such as MRMC, direct human-in-the-loop improvements, independent algorithm performance, expert ground truth establishment for AI, or training set details) will not be present.
The acceptance criteria and device performance are based on non-clinical tests required for establishing substantial equivalence for medical face masks.
Here's a summary of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Surgical Face Mask (HuBei Kangning Protective Products Co., Ltd.)
Predicate Device: Surgical Face Mask (Non-sterile) (K203426) by Nantong Taiweishi Medical Technology Co., Ltd.
ASTM F2100 Level: Level 2
| Test Methodology | Acceptance Criteria (Level 2) | Reported Device Performance (mean or range from 3 lots) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | Lot1: 31 out of 32 Pass at 120 mmHgLot2: 29 out of 32 Pass at 120 mmHgLot3: 31 out of 32 Pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.79%Lot2: 99.83%Lot3: 99.82% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%Lot2: 99.9%Lot3: 99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Lot1: 4.4 mmH2O/cm²Lot2: 4.3 mmH2O/cm²Lot3: 4.3 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Lot1: Class ILot2: Class ILot3: Class I |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates testing was performed on three different lots of the device. For specific tests like Fluid Resistance, the sample size per lot was 32 units. For other tests, such as filtration efficiencies, differential pressure, and flammability, while not explicitly stated per test, the results are reported for each of the three lots, implying samples were drawn from each lot as per the respective standard's requirements.
The data provenance is from HuBei Kangning Protective Products Co., Ltd., China, as per the applicant information. These are non-clinical (laboratory) tests, not patient-derived data, and thus are inherently "retrospective" in the sense that they were conducted on already manufactured product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a physical device (surgical face mask), not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for these tests is defined by the objective measurement procedures detailed in the referenced ASTM, EN, and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. This pertains to expert review of data, which is not relevant for the objective laboratory tests conducted for a medical face mask.
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 document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the performance and biocompatibility tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards specify the methodology and acceptable limits for each characteristic.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are laboratory validations of a physical product against established safety and performance standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set or AI component, this information is not relevant to the content of the provided document.
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