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510(k) Data Aggregation
(96 days)
This single-use surgical mask EFXPLY3SMSK is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure of blood and body fluids. This is a single use, disposable device, non-sterile.
The device is a flat pleated type mask the outer layer being blue and the inner layer being white, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLYSMSK.
The 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 material. The model EFX3PLYSMSK device 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 polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to fit the surgical mask properly around their nose. The nose bridge is made up of galvanized with polyethylene.
Here's a breakdown of the acceptance criteria and study information for the Disposable Surgical Face Mask, based on the provided document:
Acceptance Criteria and Device Performance
Level 3 Performance
| Test Methodology | Accepted Criteria (Level 3) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 160mm Hg. | 95 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 | <6.0mm H2O /cm² | 3.56 mm H2O/cm² average pressure drop across 96 samples | Pass |
| Flammability 16 CFR 1610 | Class 1 | 96 of 96 samples did not ignite | Pass |
Level 2 Performance
| Test Methodology | Accepted Criteria (Level 2) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 120mm Hg. | 96 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 | <6.0mm H2O /cm² | 3.56 mm H2O/cm² average pressure drop across 96 samples | Pass |
| Flammability 16 CFR 1610 | Class 1 | 96 of 96 samples did not ignite | Pass |
Biocompatibility
| Test Item | Accepted Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Cytotoxicity | No potential cytotoxicity | Under the conditions of the study, the device extract did not show potential toxicity to L 929 cells | Pass |
| Irritation | Non-irritating | Under the condition of the study, the device is non-irritating | Pass |
| Sensitization | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Pass |
Study Information
Due to the nature of the device (Disposable Surgical Face Mask) and the provided document, much of the requested information regarding AI/software studies is not applicable. The document describes a non-clinical performance and biocompatibility study for a physical medical device, not an AI/software-based medical device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), 96 samples of the device (EFX3PLYSMSK) were used for each test. For biocompatibility tests, the sample size is not explicitly stated in numerical terms (e.g., number of test articles), but the results indicate testing was performed.
- Data Provenance: The document does not specify the country of origin of the data directly, nor does it explicitly state whether the study was retrospective or prospective. Given these are physical performance tests, it's generally implied to be a prospective laboratory study on newly manufactured samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of study. "Ground truth" established by experts typically pertains to diagnostic accuracy studies involving image interpretation or clinical assessments, which are not relevant to the physical performance testing of a surgical mask. The acceptance criteria themselves serve as the 'ground truth' for performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to this type of study. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for objective physical performance testing against predefined criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic accuracy of AI systems, often in comparison to human reader performance, which is not relevant for a surgical mask.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. As this is a physical medical device (surgical mask), there is no AI algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is based on established regulatory standards and test methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101-19, AMST F2100-19, 16 CFR 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured against quantitative and qualitative acceptance criteria specified by these standards for surgical masks.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The samples used for testing are production samples of the device.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for it.
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(780 days)
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(287 days)
The Disposable surgical 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. This is a single use, disposable device(s), provided non-sterile.
The proposed device is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
The provided text is a 510(k) summary for a disposable surgical face mask. It does not detail a study involving AI assistance for human readers or the establishment of ground truth by multiple experts for an AI device. Instead, it focuses on demonstrating substantial equivalence of the new medical device (a surgical mask) to a legally marketed predicate device through non-clinical performance testing and biocompatibility studies.
Therefore, most of the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI, and training/test set details for an AI model cannot be extracted from this document as it pertains to a different type of medical device evaluation.
However, I can provide information based on the performance testing of the surgical mask, interpreted as its "acceptance criteria" and "device performance".
Here's the information that can be extracted:
Device Acceptance Criteria and Performance (for a Disposable Surgical Face Mask)
The acceptance criteria and performance data are based on non-clinical testing against established standards for medical face masks and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable surgical face mask, Model: AD-PR02, AD-PR02-2, AD-PR02-S01, AD-PR02-S02 manufactured by Shandong Aida Medical Products Co., Ltd) was tested against the requirements for an ASTM F2100-2020 Level 2 classification mask.
| Characteristic | Acceptance Criteria (ASTM F2100-2020 Level 2) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | ≥ 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Yes |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass (specific value: 98.46%) | Yes |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.9% | Yes |
| Differential Pressure (Delta P) | < 6.0 mmH₂O/cm² | Max: 4.8 mmH₂O/cm² Min: 4.2 mmH₂O/cm² | Yes |
| Flame Spread (16 CFR 1610) | Class 1 | Class I (Non-Flammable) | Yes |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | No potential cytotoxicity | Not showing potential toxicity to L929 cells | Yes |
| Biocompatibility: Irritation (ISO 10993-10) | Non-Irritating | Response categorized as negligible | Yes |
| Biocompatibility: Sensitization (ISO 10993-10) | Non-Sensitizing | No evidence of skin sensitization | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for specific tests are not uniformly detailed:
- Resistance to Penetration by Synthetic Blood: 32 samples were tested.
- Other performance tests (PFE, BFE, Differential Pressure, Flame Spread): Specific sample sizes are not explicitly mentioned, but the results are reported as meeting the criteria for the product.
- Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): Standard test methods (ISO 10993) would dictate the sample sizes for these biological evaluations, but specific numbers are not provided in the summary.
Data Provenance: The tests were conducted by Shandong Aida Medical Products Co., Ltd, located in China. The data were collected retrospectively as part of the 510(k) submission process to demonstrate equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this document as the device being assessed is a physical medical device (surgical mask), not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" here is defined by performance standards and laboratory test results.
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert reviews for AI/diagnostic devices to resolve discrepancies. The performance tests for a surgical mask are based on objective 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 evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a surgical mask.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective laboratory test methods and international/national standards (e.g., ASTM F2100, ASTM F2101, EN 14683, ASTM F1862, ASTM F2299, 16 CFR Part 1610, ISO 10993). These standards define the acceptable performance metrics for properties like filtration efficiency, fluid resistance, breathability, flammability, and biocompatibility.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve an AI algorithm that learns from data.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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(428 days)
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81%Lot 2: 98.78%Lot 3: 98.8% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82%Lot 2: 98.78%Lot 3: 98.79% | |||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9%Lot 2: 99.91%Lot 3: 99.91% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91%Lot 2: 99.9%Lot 3: 99.91% | |||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | N/A (listed separately below) |
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | |||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P<6.0 mm H2O/cm2 | Lot 1: 3.59Lot 2: 3.59Lot 3: 3.59 | N/A (listed separately below) |
| Tie-on | △P<6.0 mm H2O/cm2 | N/A (listed above) | Lot 1: 3.61Lot 2: 3.59Lot 3: 3.61 | |||
| 5 | Flammability | ASTM F2100-19 | Ear loop | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | N/A (listed separately below) |
| Tie-on | Class 1 | N/A (listed above) | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
Biocompatibility Tests:
| No | Item | Test Method/Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass (No potential toxicity) |
| 2 | Irritation | ISO 10993-10 | Non-irritating | Pass (No Irritation) |
| 3 | Skin Sensitization | ISO 10993-10 | Non-sensitizing | Pass (No Sensitization) |
2. Sample Size Used for the Test Set and the Data Provenance
For all performance tests (Particulates Filtration Efficiency, Bacterial Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability):
- Sample Size: 3 non-consecutive lots were tested for each type (Ear loop and Tie-on). For each lot, a sample size of 125 was used.
- Data Provenance: Not explicitly stated as country of origin, but the submission is from Lyncmed Medical Technology (Beijing) Co., Ltd. in China, implying testing was likely conducted in or for the company's region. The tests are described as "Non-Clinical Test Conclusion," meaning they were laboratory tests, not clinical studies involving human patients. The report does not specify if the provenance is retrospective or prospective for the samples used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- N/A. This is a physical medical device, and the acceptance criteria are based on standardized performance tests (e.g., ASTM, EN, ISO standards), not on human expert interpretation of data or images.
4. Adjudication Method for the Test Set
- N/A. As above, the acceptance criteria are based on objective physical and material performance 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
- N/A. This is a physical medical device, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device. No algorithm is involved.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is defined by the objective measurement criteria and threshold values specified in various international and national standards (e.g., ASTM F2299, ASTM F2101, ASTM F1862, EN 14683, ASTM F2100 for performance and ISO 10993 for biocompatibility). These standards set the quantitative benchmarks that the device must meet.
8. The Sample Size for the Training Set
- N/A. This is a physical medical device, not an AI/ML device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. This is a physical medical device. There is no "training set" and therefore no ground truth establishment for it.
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(109 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided FDA 510(k) summary describes the acceptance criteria and the study results for the Disposable Surgical Face Mask (M663BE, M663BT).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To demonstrate resistance to penetration by synthetic blood. | ASTM F2100 Level 3 29 out of 32 pass at 160 mmHg for Level 3 | Pass 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass Average 99.929%, 99.947%, 99.978% |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass Average 99.8%, 99.9%, 99.8% |
| Differential Pressure (EN 14683 Annex C) | To demonstrate the functionality of the subject device. | < 6.0 mmH2O/cm² | Pass Average 3.7 mmH2O/cm², 3.8 mmH2O/cm², 3.8 mmH2O/cm² |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | Pass, Class 1 |
| Cytotoxicity (ISO 10993-5) | To demonstrate the safety of the subject device. | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | To demonstrate the safety of the subject device. | Non-irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | To demonstrate the safety 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 the data provenance
- Fluid Resistance Test:
- Sample size: 32 samples per lot, tested across 3 lots. (Total 96 masks).
- Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility (Cytotoxicity, Irritation, Sensitization):
- The specific number of samples for each of these tests is not individually detailed in the provided summary, beyond the "3 lots" mention for fluid resistance which might imply similar lot-based testing for other performance characteristics. The results are typically reported as averages across tests.
- Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.
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 as the device is a Disposable Surgical Face Mask, and the performance evaluation relies on standardized non-clinical laboratory tests rather than expert interpretation of medical images or patient data.
4. Adjudication method for the test set
This information is not applicable as the performance evaluation relies on standardized non-clinical laboratory tests with objective pass/fail criteria, not on human interpretation or adjudication processes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a surgical face mask, and the evaluation does not involve AI or human readers for diagnostic purposes.
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 surgical face mask, and its performance evaluation does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by reference to established industrial standards and test methods. For example:
- Fluid Resistance: ASTM F1862 and ASTM F2100 Level 3.
- Particulate Filtration Efficiency: ASTM F2299.
- Bacterial Filtration Efficiency: ASTM F2101.
- Differential Pressure: EN 14683 Annex C.
- Flammability: 16 CFR 1610.
- Biocompatibility: ISO 10993 (Parts 5 and 10).
8. The sample size for the training set
This information is not applicable. The device is a surgical face mask and its development and evaluation do not involve machine learning models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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(86 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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 subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.
The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".
1. Table of Acceptance Criteria and Reported Device Performance
The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.
| Performance Testing | Test Methodology | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Reported Performance (Result for both Levels) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 99.9%, Level 3: average 99.9%) |
| Differential Pressure (mmH2O/cm²) | EN 14683:2019 Annex C | $<$ 6.0 mmH2O/cm² | $<$ 6.0 mmH2O/cm² | Passed (Level 2: average 3.45 mmH2O/cm², Level 3: average 3.65 mmH2O/cm²) |
| Sub-micron Particulate Filtration Efficiency | ASTM F2299-17 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 98.43%, Level 3: average 98.56%) |
| Resistance to Penetration by Synthetic Blood | ASTM F1862-17 | 120 mmHg | 160 mmHg | Passed (Level 2: Pass at 120mmHg, Level 3: Pass at 160mmHg) |
| Flammability | 16 CFR Part 1610-2008 | Class I | Class I | Passed (Class 1) |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Passed (Non-cytotoxic) |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Passed (Non-sensitizing) |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Passed (Negligibly irritating) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set (e.g., number of masks tested for BFE, differential pressure, etc.). It only indicates that "The Disposable Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document...".
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer or a contracted testing facility to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical face mask, and "ground truth" as typically used in AI/image analysis studies (e.g., expert consensus on medical images) is not relevant here. The performance evaluation relies on standardized laboratory test methods for physical and biological properties.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the laboratory-based performance testing of the surgical face mask, no such adjudication method is mentioned or expected. The tests follow established scientific protocols with measurable outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Surgical masks are evaluated based on their physical and biological barrier properties, not on human reader performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, this pertains to an AI/algorithm-based device, which this surgical face mask is not. The performance is the inherent protective capability of the physical mask itself, evaluated through laboratory testing.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods outlined by organizations like ASTM and ISO, and FDA guidance. These methods provide quantifiable measurements of bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, flammability, and biocompatibility. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of device performance assessment for this type of product.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a surgical face mask.
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(62 days)
The Disposable Surgical 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 Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric.
The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.
The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Disposable Surgical Face Mask. This type of medical device is generally subject to performance testing against established standards, rather than clinical studies requiring expert interpretation or AI/algorithm performance. Therefore, many of the requested elements (like MRMC studies, details on experts, ground truth for training sets, etc.) are not applicable to this specific device submission.
Here's a breakdown 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 a non-powered, non-software-driven medical device (disposable surgical face mask). Its performance is evaluated against recognized industry standards for surgical masks.
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To assess resistance to penetration by synthetic blood. | 29 out of 32 pass at 160 mmHg for level 3 | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate functionality and efficiency of materials in filtering particulates. | ≥ 98% | Pass: Average 99.1% |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate functionality and efficiency in filtering bacteria. | ≥ 98% | Pass: Average 99.5% |
| Differential Pressure (EN 14683 Annex C) | To measure breathability. | < 6.0 mmH2O/cm² | Pass: Average 3.4 mmH2O/cm² |
| Flammability (16 CFR 1610) | To assess the flammability of the material. | Class 1 | Pass: Class 1 |
| Cytotoxicity (ISO 10993-5) | To demonstrate the safety of the subject device (biological evaluation). | Non-cytotoxic | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | To demonstrate the safety of the subject device (biological evaluation). | Non-irritating | Pass: Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | To demonstrate the safety of the subject device (biological evaluation). | Non-sensitizing | Pass: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 3 lots of devices were tested, with the acceptance criteria referencing "29 out of 32 passes", implying a sample size of at least 32 masks per test lot.
- Other Performance Tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): The specific sample sizes for these tests are not detailed beyond "Average 99.1%", "Average 99.5%", "Average 3.4mmH2O/cm²", and "Class 1", which usually indicates an average or singular result from a batch of samples tested according to the respective standards.
- Biocompatibility Tests (Cytotoxicity, Irritation, Sensitization): These tests are performed on extracts from the device material according to ISO 10993 standards. Specific sample sizes for the biological assays are not provided, but the conclusions ("non-cytotoxic," "non-irritating," "non-sensitizing") reflect the results from the required in-vitro or in-vivo tests.
Data Provenance: The tests were conducted as "Non-clinical tests" to verify that the proposed device met design specifications for the standards and test methods. The origin of the testing (e.g., country of actual lab) is not specified, but the applicant (FOMED INDUSTRIES INC.) is based in China. These are prospective tests performed specifically for device clearance.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The device is a surgical mask, and its performance is evaluated through standardized laboratory tests, not by human experts establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by objective physical and biological test results against defined numerical and qualitative criteria in recognized standards, not by expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was done as the device is not an AI-assisted diagnostic or triaging tool.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical product (face mask), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device is based on established industry standards and test methodologies for medical face masks and biocompatibility, such as ASTM F2100, F1862, F2299, F2101, EN 14683, 16 CFR 1610, and ISO 10993. These standards define the acceptable performance limits for each characteristic.
8. Sample Size for the Training Set
Not applicable. This is a physical non-software medical device, so there is no "training set" in the context of machine learning or algorithms. The manufacturing process is subject to quality control, but this is distinct from training data for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, this question is not relevant. The device manufacturer adheres to Good Manufacturing Practices (GMP) and ISO 13485 standards for quality management during production, ensuring consistency with the tested samples.
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(196 days)
The surgical 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 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/sterile.
The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering. In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer). The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices. The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.
This document primarily concerns the regulatory approval (510(k) clearance) of a medical device, specifically a Disposable Surgical Face Mask, by the FDA. The information provided heavily focuses on non-clinical performance testing against established standards, rather than the type of clinical study involving human-in-the-loop performance or expert consensus typically found in AI/CADe device submissions.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available within this document because the device is a physical product (a face mask) and its evaluation relies on established material and performance standards, not on image interpretation or diagnostic algorithms.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Disposable Surgical Face Mask
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements for Level 3 as specified in ASTM F2100-19 and other relevant standards.
| Test (Standard) | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Performance (Disposable Surgical Face Mask) | Reported Performance (Disposable Surgical Mask (Sterile)) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Pass at 160 mmHg | 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.5%~99.7% (Average: 99.6%) | 99.7%~99.9% (Average: 99.8%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.37%~99.99% (Average: 99.74%) | 99.32%~99.85% (Average: 99.63%) |
| Differential Pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | < 6.0 mmH2O/cm² | (3.4~4.2) mmH2O/cm² (Average: 3.9 mmH2O/cm²) | (3.5~4.5) mmH2O/cm² (Average: 4.0 mmH2O/cm²) |
| Flammability (16 CFR 1610) | Verify the flammability of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Class 1 | Class 1 | Class 1 |
| Biocompatibility - In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass | Pass |
| Biocompatibility - Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass | Pass |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability), the document states "Statistics of three lots, 32 per lot," which means a total of 96 samples were tested for each performance criterion.
- Data Provenance: The document does not explicitly state the country of origin where the tests were performed, but the manufacturer is National Bridge Industrial (S.Z.) Co., Ltd. in China, and the submission correspondent is Shenzhen Joyantech Consulting Co. Ltd, also in China. These were non-clinical (laboratory) tests, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The ground truth for this device (a surgical face mask) is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards) measuring physical properties like filtration efficiency and fluid resistance, not through expert human interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, the evaluation relies on objective, quantifiable measurements from laboratory tests, not subjective assessments requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers' performance is compared with and without AI assistance. This document describes the testing of a physical medical device (face mask).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithmic or software-based device. "Standalone" performance would refer to the device's inherent physical characteristics as measured by the non-clinical tests listed.
7. The Type of Ground Truth Used
- The "ground truth" for the surgical face mask is defined by established engineering and material performance standards (e.g., ASTM F2100-19, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 for biocompatibility) and the test methodologies prescribed within them. These standards define the acceptable range or threshold for various physical and biological properties.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set was used.
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(181 days)
The Disposable Surgical 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose. The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8. 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, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene. The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document primarily details the substantial equivalence determination for a Disposable Surgical Face Mask (K211696) to a predicate device (K133070). The acceptance criteria and "study" mentioned in the document refer to a series of non-clinical performance and biocompatibility tests conducted on the proposed device to demonstrate that it meets established standards for surgical masks, specifically ASTM F2100 Level 3 requirements.
Here's the breakdown of the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology (Non-Clinical) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (Particulate Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| ASTM F1862-17 Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity) (Fluid Resistance Performance) | Level 3, No penetration at 160mmHg | Passed at 160 mmHg (for 3 lots) |
| ASTM F2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (Bacterial Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| Differential Pressure (Delta P) EN14683:2019, Annex C and ASTM F2100-19 (Breathability) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² (Passed for 3 lots) |
| MIL-M-36954C Military Specification - Mask, Surgical, Disposable 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES (Flammability) | Class 1, (Burn time ≥3.5 seconds, IBE, or DNI) | IBE (Passed for 3 lots) |
| ISO 10993-5: 2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility - Cytotoxicity) | Not cytotoxicity effect to L-929 in the MTT method | Not cytotoxicity effect (Passed) |
| ISO 10993-10: 2010, Biological Evaluation Of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility - Irritation) | Negligible dermal irritation in rabbit | Not an Irritant (Passed) |
| ISO 10993-10: 2010, Biological Evaluation Of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility - Sensitization) | Not cause delayed dermal contact sensitization in guinea pig | Not a sensitizer (Passed) |
2. Sample Size Used for the Test Set and Data Provenance:
- For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The document mentions testing across 3 product lots (LOT NO.: CR202101, CR202102, CR202103). For each lot, 32 samples were tested for Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability.
- For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The document does not specify a numerical sample size but states "Under the conditions of the study" for each. However, these are standard biological evaluation tests that would have followed specific sample size requirements outlined in the referenced ISO standards.
- Data Provenance: The device is manufactured by Anhui Cleanpro Pharmpack Co., Ltd. in Tianchang, Anhui, China. The testing was conducted as part of their submission to the FDA. The tests are non-clinical (laboratory-based) and are likely retrospective in the context of this 510(k) submission, as they were performed to demonstrate compliance of an already manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to this submission. The "ground truth" here is defined by established international and national standards (ASTM, MIL-M, ISO) for medical device performance and biocompatibility. The tests are objective measurements against these predefined criteria, not subjective expert interpretations of clinical images or findings. Therefore, no "experts" for establishing ground truth in the traditional sense of clinical studies (e.g., radiologists) were involved.
4. Adjudication Method for the Test Set:
This is not applicable. The tests performed are objective, quantitative measurements against specified thresholds, 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:
This is not applicable. This submission is for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. This submission is for a physical medical device.
7. The Type of Ground Truth Used:
The "ground truth" is based on established standard specifications and thresholds for surgical face masks as defined by:
- ASTM F2299-03
- ASTM F1862-17
- ASTM F2101-19
- MIL-M-36954C / 16 CFR 1610
- EN14683:2019
- ISO 10993-5: 2009
- ISO 10993-10: 2010
These standards define the acceptable performance limits for fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical device like a surgical mask based on non-clinical performance and biocompatibility testing. This concept applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reason stated above.
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(154 days)
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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 Disposable Surgical Face Mask is 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 exposure to microorganisms and body fluids.
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. 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 Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | ASTM F2100 Level (if applicable) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862M-17) | 160 mmHg (Level 3) | 95 of 96 samples passed at 160mmHg | Level 3 |
| Particulate Filtration Efficiency (PFE) (ASTM F2299-03) | ≥98% | 96/96 samples passed at ≥98% | Level 3 |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥98% | 94/96 samples passed at ≥98% | Level 3 |
| Differential Pressure (EN 14683 Annex C) | <6.0 mmH2O/cm² | 92/96 samples passed at <6 mmH2O/cm² | Level 3 |
| Flammability (16 CFR Part 1610) | Class 1 (≥3 seconds burn time) | 96/96 samples passed at ≥3 seconds burn time - Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Device was non-cytotoxic | N/A |
| Irritation (ISO 10993-10:2010) | Non-irritating | Device was non-irritating | N/A |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Device was non-sensitizing | N/A |
2. Sample Size Used for the Test Set and Data Provenance
- For the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability): 3 lots tested with a total of 96 samples for each test (e.g., 32 samples per lot).
- Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., whether the tests were conducted in China where the manufacturer is located or another country). It also does not specify if the studies were retrospective or prospective, though performance testing of physical products is generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the document describes performance testing of a physical medical device (surgical face mask) against established technical standards, not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable for the type of testing described (physical product performance against quantitative standards). Pass/fail criteria are defined by the standards themselves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable as the document describes the performance testing of a physical medical device (surgical face mask), not an AI/software device or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable as the document pertains to a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is based on pre-defined technical standards (e.g., ASTM F2101-19, EN 14683, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993) which specify quantitative measurements and thresholds for acceptable performance. Biocompatibility (cytotoxicity, irritation, sensitization) is also assessed against established biological standards.
8. The Sample Size for the Training Set
- This information is not applicable as the document describes performance testing of a physical medical device, which does not involve a training set as used in machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the document does not relate to machine learning or AI and therefore does not have a "training set" or corresponding ground truth establishment process.
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