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510(k) Data Aggregation
(162 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.
However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.
1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:
The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."
Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)
| Test Item & Purpose | Acceptance Criteria (Level 2) | Reported Performance (Level 2) | Acceptance Criteria (Level 3) | Reported Performance (Level 3) | Result (Both Levels) |
|---|---|---|---|---|---|
| Performance Test: Flammability | Class 1 (ASTM F2100) | Class 1 | Class 1 (ASTM F2100) | Class 1 | Pass |
| Purpose: Testing the characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion. | |||||
| Performance Test: Bacterial Filtration Efficiency (BFE) | ≥ 98% (ASTM F2100) | Average at 99.66% | ≥ 98% (ASTM F2100) | Average at 99.58% | Pass |
| Purpose: Testing the effectiveness of medical face mask material in preventing the passage of aerosolized bacteria. | |||||
| Performance Test: Differential Pressure (mm H2O/cm²) | < 6.0 (ASTM F2100) | 4.4 mm H2O/cm² | < 6.0 (ASTM F2100) | 5.06 mm H2O/cm² | Pass |
| Purpose: Measuring the pressure drop across a medical face mask material. | |||||
| Performance Test: Sub-Micron Particle Filtration Efficiency (PFE) | ≥ 98% (ASTM F2100) | Average at 99.54% | ≥ 98% (ASTM F2100) | Average at 99.67% | Pass |
| Purpose: Testing the efficiency of the filter material in capturing aerosolized particles smaller than one micron. | |||||
| Performance Test: Resistance to Penetration by Synthetic Blood | Pass at 120 mmHg (ASTM F2100) | Passed at 120 mmHg (≥29 out of 32 samples passed) | Pass at 160 mmHg (ASTM F2100) | Passed at 160 mmHg (≥29 out of 32 samples passed) | Pass |
| Purpose: Testing the efficiency of resistance to penetration by synthetic blood. | |||||
| Biocompatibility: Cytotoxicity | Grade ≤ 2 (ISO 10993-5) | Not explicitly stated as "Pass" but under "Comparison Table" it says "Fail" for both levels against the predicate's "not cytotoxic" | Grade ≤ 2 (ISO 10993-5) | Not explicitly stated as "Pass" but under "Comparison Table" it says "Fail" for both levels against the predicate's "not cytotoxic" | Fail |
| Purpose: Determining the cytotoxicity of proposed device. | |||||
| Biocompatibility: Sensitization | Sensitization classification grade < 3 (ISO 10993-10) | Not a sensitizer | Sensitization classification grade < 3 (ISO 10993-10) | Not a sensitizer | Pass |
| Purpose: Determining whether the proposed device has sensitization potential. | |||||
| Biocompatibility: Skin Irritation | Reaction score is 1, 0 or less (ISO 10993-10) | Not an irritant | Reaction score is 1, 0 or less (ISO 10993-10) | Not an irritant | Pass |
| Purpose: Determining whether the proposed device has irritation potential. | |||||
| Biocompatibility: Acute Systemic Toxicity | Less than 2 animals appear clinical abnormal and body weight loss ≤ 10% (ISO 10993-11) | No systemic toxicity from the device | Less than 2 animals appear clinical abnormal and body weight loss ≤ 10% (ISO 10993-11) | No systemic toxicity from the device | Pass |
| Purpose: Determining whether the proposed device has systemic toxicity potential. | |||||
| Simulated Transportation | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | Pass |
| Purpose: Determining the ability of shipping units to withstand the distribution environment. |
Note on Cytotoxicity: The comparison table explicitly states "Fail" for cytotoxicity, even though the reported result in the detailed performance tables states "show potential cytotoxicity" and a criterion of "Grade ≤ 2". This is a critical point of difference from the predicate device which was "not cytotoxic." The FDA's clearance likely implies that this difference did not raise new questions of safety or effectiveness given the overall risk-benefit profile for this type of device.
2. Sample size used for the test set and the data provenance:
- Sample Size: For Flammability, Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particle Filtration Efficiency, and Resistance to Penetration by Synthetic Blood, the testing was conducted on samples from "3 non-consecutive lots." The number of individual samples tested per lot is indicated for Flammability and Resistance to Penetration by Synthetic Blood, showing 32 out of 32 pass for flammability and ≥29 out of 32 pass for synthetic blood penetration. The exact sample sizes for BFE, Differential Pressure, and PFE for each lot are not explicitly stated as a count, but they are implied to be sufficient for generating the reported average percentages/values from the 3 lots.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission from "Foshan Nanhai Plus Medical CO LTD" in China. The testing appears to be retrospective as it is presented as completed performance data for a device already manufactured.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the tests described. The "ground truth" for the performance tests (e.g., BFE, PFE) is established by the standardized testing protocols (e.g., ASTM F2100) and laboratory measurements, not by expert consensus or interpretation of images/clinical data. For biocompatibility, it's based on standard biological evaluation protocols (e.g., ISO 10993 series).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests are laboratory-based measurements with defined pass/fail criteria, not subjective assessments requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document pertains to a physical medical device (surgical face mask) and its performance characteristics, not an AI/Machine Learning algorithm. No MRMC study was conducted or is relevant to this device's evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is derived from standardized physical and chemical testing methods using established protocols (e.g., ASTM F2100 for filtration, differential pressure, flammability, synthetic blood penetration; ISO 10993 for biocompatibility). The results are quantitative measurements against predefined criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device; thus, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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(100 days)
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1
Level 3 Surgical mask model (Tie-on): XT10B1
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
The provided text is a 510(k) summary for a surgical mask (K211454) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information related to AI performance, human reader improvement with AI, or MRMC studies is not available in this document.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology (standard) | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862-17 | Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | Lot 1# pass at 160mmHg; Lot 2# pass at 160mmHg; Lot 3# pass at 160mmHg |
| ASTM F2101-19 | Bacterial Filtration Efficiency Performance | ≥ 98% | Lot 1# 99.7%-99.9%; Lot 2# 99.7%-99.9%; Lot 3# 99.7%-99.9% |
| EN 14683:2019 | Differential Pressure (Delta-P) | < 6.0mm H2O/cm² | Lot 1# 2.3-4.6; Lot 2# 2.3-4.5; Lot 3# 2.0-3.9 |
| ASTM F2299-2007 | Particulate Filtration Efficiency Performance | ≥ 98% | Lot 1# 99.2%-99.8%; Lot 2# 99.0%-99.7%; Lot 3# 99.3%-99.7% |
| 16 CFR Part 1610 | Flammability | Class I | Lot 1# Class I; Lot 2# Class I; Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device was non-cytotoxic |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, the subject device was non-sensitizing |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, the subject device was non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions testing "Lot 1#", "Lot 2#", and "Lot 3#" for Fluid Resistance, Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, and Flammability. For Fluid Resistance, it specifies "32 Out of 32 pass", indicating a sample size of 32 for that particular test per lot. The exact sample sizes for other performance tests are implied by the "Lot #" reporting but not explicitly stated numerically as a single count per test.
The data provenance is from non-clinical performance testing conducted on the proposed device's materials and finished products, performed by Jiangsu Xingtong Biotechnology Group Co., Ltd. through various standard test methodologies (e.g., ASTM, EN, ISO). This is prospective testing of the manufactured device. There is no indication of country of origin for the specific data collection, but the manufacturer is based in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical study involving standardized physical, chemical, and biological tests, not subjective expert evaluation of medical images or conditions. The "ground truth" is established by the predefined acceptance criteria of the testing standards.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical testing against standardized criteria, there is no need for expert adjudication. The tests have objective outcomes against set thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for a surgical mask and relies on non-clinical performance and biocompatibility testing for substantial equivalence, not AI or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. This device is a physical surgical mask, not an AI-powered diagnostic or therapeutic device.
7. The Type of Ground Truth Used
The ground truth for evaluating the surgical mask's performance is based on pre-defined acceptance criteria set by international and national standards for medical device performance and biocompatibility. These include:
- Physical performance standards: ASTM F1862-17 (Fluid Resistance), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 (Differential Pressure), ASTM F2299-2007 (Particulate Filtration Efficiency), 16 CFR Part 1610 (Flammability).
- Biocompatibility standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation).
- Sterilization validation standards: ISO 11135:2014, ISO 11737-1:2018, ISO 10993-7:2008.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, no training set for an algorithm was used.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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(134 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical 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 non-sterile.
The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, provided non-sterile.
The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine the ability of the mask's material to resist penetration of blood and body fluids. | Pass/fail basis at any of three velocities corresponding to the range of human blood pressure:Level 1 – 80 mmHgLevel 2 – 120 mmHgLevel 3 - 160 mmHg | Level 3Passed at 160 mmHg.All 3 lots tested passed with no synthetic blood penetration observed at 160 mmHg, under the conditions of the test. |
| Particulate Filtration Efficiency (ASTM F2299) | Determine the ability of the mask's material to prevent passage of aerosolized submicron particulates. | Pass/fail basis:Level 1 – 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at > 99.9%Average Filtration Efficiency:AMSB-LOT202010007: >99.979%AMSB-LOT202011002: >99.9814%AMSB-LOT202011005: >99.984% |
| Bacterial Filtration Efficiency (ASTM F2101-19) | Determine the ability of the mask's material to prevent passage of aerosolized bacteria. | Pass/fail basis:Level 1 - 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at ≥ 99.9%All samples tested passed with a filtration efficiency percentage of at least 99.9%, under the conditions of the test. |
| Differential Pressure (ASTM F2101-19, same as BFE) | Determine the resistance of the surgical facemask to air flowing through the mask. | Pass/fail basis:Level 1 – <5 mm H2O/cm²Level 2 – <6 mm H2O/cm²Level 3 – <6 mm H2O/cm² | Level 1Passed, < 5 mm H2O/cm².AMSB-LOT202010007: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011002: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011005: ≤ 4.9 mm H2O/cm2. |
| Flammability (16 CFR Part 1610) | Determine the ability of the mask to resist ignition to an externally applied ignition source. | Pass/fail basis:Class 1, normal flammability specified in 16 CFR Part 1610. | Passed at Class 1All samples tested achieved a Class 1 flammability rating under the conditions of the test. |
Additionally, for safety (biocompatibility), Table 3: Summary of Biocompatibility Test Result and Comparison on page 8 details:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5) | Determine the biological response of mammalian cells in-vitro | Non-cytotoxic | Under the conditions of the study, non-cytotoxicity effect |
| Skin-irritation (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce skin irritation | Non-irritating | Under the conditions of the study, non-irritation |
| Sensitization (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce host sensitization | Non-sensitizing | Under the conditions of the study, non-sensitization |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For the Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency/Differential Pressure, and Flammability tests, the report states "All 3 lots tested" for fluid resistance and "All samples tested" for the other filtration/flammability tests, with specific lot numbers provided for filtration efficiency and differential pressure (AMSB-LOT202010007, AMSB-LOT202011002, AMSB-LOT202011005). The exact number of masks or specimens per lot is not explicitly stated, but it's implied that multiple samples were taken from these lots. ASTM and ISO standards for these tests typically specify precise sample quantities.
- Sample Size for Biocompatibility Tests: "All samples met the test criteria" is stated, but the exact number of samples or specimens per biocompatibility test (Cytotoxicity, Skin-irritation, Sensitization) is not specified.
- Data Provenance: The device manufacturer is Changzhou Holymed Products Co., Ltd. in Jiangsu, China. The testing appears to be non-clinical (laboratory-based) and conducted to conform to international standards (ASTM, ISO, CFR). The document does not specify where the testing was physically performed (e.g., in China or a certified third-party lab elsewhere), but it would typically be done in a lab accredited for these specific tests. The data is retrospective in the sense that it was collected as part of the 510(k) submission prior to the FDA's review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for performance of a surgical mask (e.g., filtration efficiency, fluid resistance) is objectively determined by standardized laboratory tests using established scientific methods and equipment, not by human expert opinion or consensus. Similarly, biocompatibility is assessed by laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. Since the performance metrics are objective physical measurements and chemical/biological assay results, there is no need for expert adjudication. The test results directly determine if the acceptance criteria are met.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are typically performed for diagnostic medical devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is evaluated. This 510(k) submission is for a physical product (surgical mask) that does not involve human interpretation or AI assistance in a diagnostic context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical mask, not an algorithm or software. The "standalone" performance here refers to the physical properties of the mask itself, which are tested through the described non-clinical laboratory studies. There is no algorithm involved.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective, standardized laboratory measurements against established national and international standards (ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards define the test methodologies and the acceptance criteria based on scientific principles relevant to the function and safety of a surgical mask.
- Fluid Resistance: Measured penetration of synthetic blood.
- Particulate Filtration Efficiency: Measured percentage of submicron particulates filtered.
- Bacterial Filtration Efficiency: Measured percentage of aerosolized bacteria filtered.
- Differential Pressure (Breathability): Measured resistance to airflow.
- Flammability: Measured ignition and burn rate.
- Biocompatibility: Measured cellular response (cytotoxicity), skin irritation, and sensitization potential.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device (surgical mask), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. The manufacturing process involves quality control, but not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set. As explained above, for a physical product like a surgical mask, the performance validation relies on standardized physical, chemical, and biological testing rather than machine learning models that require training and ground truth from data sets.
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(165 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria for ASTM Level 2 | Reported Device Performance (Surgical Mask - K203064 Level 2) | Acceptance Criteria for ASTM Level 3 | Reported Device Performance (Surgical Mask - K203064 Level 3) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | Pass @ 120 mmHg | Pass @ 120 mmHg | Pass @ 160 mmHg | Pass @ 160 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 99.8% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 99.8% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ >99% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ >99% |
| Differential Pressure (EN 14683:2019 Annex C) | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 5.1mm H₂O/cm² | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 5.1mm H₂O/cm² |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO10993-1, -5, -10) | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document for the performance tests. The document only mentions that the device "meets the requirements" or "Passed" these tests. For Biocompatibility testing, the document states "No cytotoxicity or cell lysis was noted" and "No evidence of sensitization or irritation was observed," implying a sufficient number of samples were tested to reach these conclusions, but the exact number isn't given.
- Data Provenance: Not specified. The tests are referred to as "Non-Clinical Performance Testing," suggesting they were conducted in a laboratory setting, not on human subjects. There's no mention of country of origin for the data or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical mask, and the evaluation relies on technical performance standards (ASTM, EN, CFR, ISO) rather than expert interpretation of images or clinical outcomes. The "ground truth" is defined by the passing criteria of the specified standards.
4. Adjudication method for the test set:
- Not applicable. The "ground truth" is determined by meeting the objective pass/fail criteria of the specified technical standards, not through expert 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 study was done. This is a surgical mask, not an AI-powered diagnostic device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (surgical mask), not an algorithm or AI system. The performance tests are for the physical properties of the mask.
7. The type of ground truth used:
- Objective Technical Standards/Specifications: The ground truth for this device's performance is established by its ability to meet the quantitative and qualitative criteria defined by recognized standards such as ASTM F1862-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR Part 1610, and ISO 10993 series for biocompatibility.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
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