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510(k) Data Aggregation
(133 days)
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
The Nordiwell Medical Face Mask has a flat-folded design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has earloops or tie strings to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. This is a single use, disposable device, provided non-sterile.
This document is a 510(k) Premarket Notification for a medical face mask. It does not describe an AI/ML powered medical device, but rather a physical product. Therefore, many of the requested criteria regarding AI/ML model evaluation (e.g., training set, ground truth acquisition, MRMC studies, standalone performance with human-in-the-loop, number of experts for ground truth) are not applicable.
However, I can extract the acceptance criteria and performance data for this physical medical device from the provided text.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance | Study Conclusion |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥ 29 of 32 pass at 120 mmHg | 31 of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | 99.9%, 32 of 32 pass | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | 99.9%, 32 of 32 pass | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | < 6.0 mmH2O/cm² | 4.6 mmH2O/cm², 32 of 32 pass | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1, 32 of 32 pass | Pass |
| Biocompatibility (ISO 10993 series) | Non-Cytotoxic, Non-Irritating, Non-Sensitizing | Non-Cytotoxic, Non-Irritating, Non-Sensitizing | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests: For each performance test (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the sample size was 32 units. The document also states "Bench test was conducted on 3 nonconsecutive lots of Medical Face Mask". This implies 32 units per lot, or a total of 32 units drawn across 3 nonconsecutive lots. The wording "32 of 32 pass" for each specific test strongly suggests that the sample size for each test was 32.
- Data Provenance: The tests were conducted internally by the manufacturer (Changzhou Combat Protective Equipment Co., Ltd.) in China, as indicated by the contact information and location. The studies are essentially prospective in nature, as they involve testing newly manufactured devices to verify performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical product, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" here is the result of standardized physical and biological tests conducted against established ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical product. Test results are objective measurements from laboratory equipment and procedures, not subjective human interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML medical device. No human reader studies were conducted as the device is a medical face mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device's performance is based on established international and national standards (ASTM F1862-17, ASTM F2299-17, ASTM F2101-19, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the test methodologies and acceptance criteria for medical face masks. The testing is performed in laboratory settings to objectively measure the device's physical and biological properties.
8. The sample size for the training set
- Not Applicable. This is a physical product, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical product, not an AI/ML device.
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(46 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | 160 mmHg | 32 of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% at 0.1 micron | > 99.9% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | ≥ 98% |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | 5.6 mmH2O/cm² |
| Flammability | Class 1 | Class 1 |
| Biocompatibility: | ||
| - In Vitro Cytotoxicity | Non-cytotoxic | Non-Cytotoxic |
| - Skin Irritation | Non-irritating | Non-Irritating |
| - Skin Sensitization | Non-sensitizing | Non-Sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test, but it indicates "32 of 32 pass" for fluid resistance, implying a sample size of 32 for that particular test. The data provenance is implied to be from the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., based in China, as per the contact information provided in the 510(k) summary. The studies are non-clinical (bench testing) and therefore not retrospective or prospective in the human study sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies are non-clinical bench tests comparing the device's physical properties against established industry standards (ASTM F2100). No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical bench tests for physical properties according to standardized methods. No human adjudication was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The device is a surgical face mask, and performance is evaluated through bench testing against established standards, not through reader studies.
6. Standalone Performance Study
Yes, a standalone study was done. The document explicitly states: "Bench testing was conducted to demonstrate the performance of the subject device." The results of these bench tests are presented against the ASTM F2100 Level 3 criteria, indicating the algorithm's (device's) standalone performance for various physical and filtration properties.
7. Type of Ground Truth Used
The ground truth used for evaluation is established industry standards (ASTM F2100 Level 3) for surgical face mask performance and international standards for biocompatibility (ISO 10993 series). These are objective, quantifiable criteria.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an AI algorithm or a device requiring a training set in that context. The "training set" concept is irrelevant to a physical product's performance validation against standards.
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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(113 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years.
The provided text describes the acceptance criteria and the study conducted for the Nordiwell Medical Face Mask (K202615) to demonstrate substantial equivalence to a predicate device. This is a medical device, specifically a surgical face mask, not an AI/ML powered device. Therefore, many of the requested categories in the prompt, such as those related to AI model performance, expert ground truth, adjudication methods, and training/test sets for AI, are not applicable.
Here's the information that can be extracted from the provided text, focused on the device's physical and performance characteristics:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nordiwell Medical Face Mask (K202615)
| Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-17) | ≥29 of 32 pass at 160 mmHg | 32 of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | > 99.9% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | > 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | <6.0 mmH2O/cm² | 5.6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| In Vitro Cytotoxicity Test (ISO 10993-5: 2009) | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Skin Irritation Test (ISO 10993-10:2010) | Non-Irritating | Non-Irritating | Pass |
| Skin Sensitization Test (ISO 10993-10:2010) | Non-Sensitizing | Non-Sensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document indicates that for fluid resistance testing (ASTM F1862-17), a sample size of 32 units was used for testing against the acceptance criteria of "≥29 of 32 pass". For the shelf-life accelerated aging test, 3 non-consecutive lots were used (sample size per lot not specified for each performance test, but it can be inferred that appropriate sample sizes were used for each test on these lots).
Data Provenance: The tests were conducted internally by the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., in China, or by their designated testing facilities. The data is prospective, generated specifically for this 510(k) submission.
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 physical medical face mask. Ground truth is established through standardized laboratory bench testing rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods are relevant for subjective assessments, typically in clinical or image-based studies. The performance of this device is measured using objective, standardized bench tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This is a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from objective measurements against established industry standards and regulatory criteria through bench testing (e.g., ASTM and EN standards for filtration, pressure, flammability, and ISO standards for biocompatibility).
8. The sample size for the training set
Not Applicable. This product is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, this question is not relevant.
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