Search Results
Found 2 results
510(k) Data Aggregation
(101 days)
The Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) 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 a single use, disposable device(s), provided non-sterile.
The proposed device (model: 15604F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15704F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15604F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15704F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and performance data for a Level 3 Fluid Resistant Procedure/Surgical Mask (models 15604F, 1570F). This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Result 1 (Model: 15604F) | Result 2 (Model: 15704F) |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.5%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.74%, Lot2: 99.85%, Lot3: 99.85% for 3 non-consecutive lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.4%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.7%, Lot2: 99.8%, Lot3: 99.7% for 3 non-consecutive lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | < 6.0 mmH2O/cm² | PASS (Lot1: 4.57 mmH2O/cm², Lot2: 4.72 mmH2O/cm², Lot3: 4.72 mmH2O/cm² for 3 non-consecutive lots) | PASS (Lot1: 4.60 mmH2O/cm², Lot2: 4.70 mmH2O/cm², Lot3: 4.70 mmH2O/cm² for 3 non-consecutive lots) |
| Flammability (16 CFR 1610) | Assess the resistance of a mask to ignition | Class 1 | PASS (Class 1 for 3 non-consecutive lots) | PASS (Class 1 for 3 non-consecutive lots) |
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) | PASS (Under the conditions of the study, the device is non-irritating.) |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability tests, a sample size of 32 per lot was used, across 3 non-consecutive lots.
- For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number but the results indicate "Under the conditions of the study."
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications and was similar to the predicate device. The document does not specify the country of origin of the test data or explicitly state whether the studies were retrospective or prospective, but these are standard laboratory tests conducted to evaluate product performance. Given the context of a 510(k) submission, these are typically prospective tests conducted on manufactured samples.
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 to this type of device and study. The "ground truth" for the performance of a surgical mask is established by validated standardized testing methods (e.g., ASTM, EN, ISO standards), not by expert consensus in a medical imaging or diagnostic sense. The results are quantitative measurements against predefined criteria.
4. Adjudication method for the test set
This information is not applicable. As these are objective, quantitative laboratory tests based on recognized standards, an adjudication method for reconciling expert opinions is not relevant. The results are measured values compared against specific acceptance criteria.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical imaging) where human interpretation is involved. For a surgical mask, the performance is evaluated through physical and biological laboratory tests, not human interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical medical product (a surgical mask), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective measurements against established industry standards and regulatory requirements. These include:
- ASTM F1862 (Fluid Resistance)
- ASTM F2299 (Particulate Filtration Efficiency)
- ASTM F2101 (Bacterial Filtration Efficiency)
- EN 14683 Annex C (Differential Pressure)
- 16 CFR 1610 (Flammability)
- ISO 10993 (Biocompatibility - Cytotoxicity, Irritation, Sensitization)
8. The sample size for the training set
Not Applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product subject to standardized performance testing.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for this type of device, the concept of establishing ground truth for a training set does not apply.
Ask a specific question about this device
(86 days)
The Fluid Resistant Procedure/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 intection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device (model: 15603F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15703F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15603F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15703F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
This appears to be a 510(k) summary for a medical device (Fluid Resistant Procedure/Surgical Mask), which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study with human readers or clinical outcomes. Therefore, many of the requested points related to AI/human reader studies, expert ground truth, and training data will not be applicable.
However, based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Proposed Device (Model: 15603F) Performance | Proposed Device (Model: 15703F) Performance | Result (for both models) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg for level 2 | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.15%, Lot2: 99.22%, Lot3: 99.22%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.03%, Lot2: 99.10%, Lot3: 99.30%. | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.40%, Lot2: 99.50%, Lot3: 99.60%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.20%, Lot2: 99.30%, Lot3: 99.30%. | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm2 | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 3.55 mmH2O/cm2, Lot2: 3.59 mmH2O/cm2, Lot3: 3.60 mmH2O/cm2. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 3.59 mmH2O/cm2, Lot2: 3.58 mmH2O/cm2, Lot3: 3.56 mmH2O/cm2. | PASS |
| Flammability (16 CFR 1610) | Class 1 | 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1. | 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1. | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | "Under the conditions of the study, the device is non-cytotoxic." (Summary of biological evaluation, implying a test was performed according to ISO 10993-5) | "Under the conditions of the study, the device is non-cytotoxic." (Summary of biological evaluation, implying a test was performed according to ISO 10993-5) | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | "Under the conditions of the study, the device is non-irritating." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10) | "Under the conditions of the study, the device is non-irritating." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10) | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | "Under the conditions of the study, the device is non-sensitizing." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10, as irritation and sensitization are often evaluated together or in closely related parts of the ISO 10993 series). | "Under the conditions of the study, the device is non-sensitizing." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10, as irritation and sensitization are often evaluated together or in closely related parts of the ISO 10993 series). | PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability): For each performance test, 3 non-consecutive lots were tested, with a sample size of 32 per lot. This means a total of 96 samples per test (3 lots * 32 samples/lot).
- Sample Size for biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The document states "Under the conditions of the study," implying standard sample sizes for these in vitro/in vivo biological tests as per ISO 10993, but the exact number for this specific submission is not explicitly stated.
- Data Provenance: The tests were conducted by Zhejiang Lanhine Medical Products LTD, located in Cixi City, Zhejiang Province, China, as part of their 510(k) submission to the FDA. The data is retrospective in the sense that the tests were performed on manufactured devices and the results are reported.
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 this is a submission for a physical medical device (surgical mask) based on performance testing against international standards, not an AI software where expert-established ground truth is typically required. The "ground truth" here is the established performance standard itself (e.g., ≥ 98% BFE).
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. The results are quantitative measurements against predefined thresholds, not subjective 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
This information is not applicable. This submission is for a physical medical device, not an AI software device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for this device's acceptance is based on established international and national performance standards and regulatory requirements. Specifically:
- Performance Standards: ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610 (flammability). These standards define the acceptable range for the physical and filtration properties of the mask.
- Biocompatibility Standards: ISO 10993-5, ISO 10993-10. These standards define the acceptable limits for biological responses to materials.
The "ground truth" is therefore objective, measurable criteria defined by these standards.
8. The sample size for the training set
This information is not applicable. This 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
This information is not applicable as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1