Search Results
Found 1 results
510(k) Data Aggregation
(155 days)
The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.
This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) | To determine the bacterial filtration efficiency (BFE) of the test article. | $\ge 98%$ | Average 98.61% |
| Particulate Filtration Efficiency (PFE) | To determine the Particle Filtration Efficiency. | $\ge 98%$ | Average 98.58% |
| Differential Pressure (Breathability) | To determine the differential pressure, indicating how easily one can breathe through the mask. | $< 6.0 \text{ mm H2O/cm}^2$ | Average 4.41 mm H2O/cm² |
| Flammability | To evaluate the flammability of the test sample. | Class I | Class I |
| Cytotoxicity (ISO 10993-5) | To assess if the device extract is cytotoxic. | Non-cytotoxic | Non-cytotoxic |
| Sensitization (ISO 10993-10) | To assess if the device extract is sensitizing. | Non-sensitizing | Non-sensitizing |
| Irritation (ISO 10993-10) | To assess if the device extract is irritating. | Non-irritating | Non-irritating |
2. Sample Sizes and Data Provenance
- Sample Sizes: The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of masks tested for BFE, PFE, etc.). It only provides the average results for some tests.
- Data Provenance: The tests were conducted to support a submission from Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China. The data is from non-clinical laboratory testing performed on the physical samples of the medical masks. Since these are performance tests of a physical product, they are by definition prospective with respect to the testing itself, i.e., new samples are manufactured and then tested.
3. Number of Experts and Qualifications
- This document describes non-clinical performance testing of a physical device (medical mask). Therefore, it does not involve human expert consensus for establishing ground truth or evaluating diagnostic performance. The "ground truth" here is based on the standardized test methods and their defined outcomes.
4. Adjudication Method
- Not applicable. This is not a study requiring adjudication of expert opinions for ground truth. The tests are objective measurements based on standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This document explicitly states: "No clinical study is included in this submission." The testing is purely non-clinical, focusing on the physical and performance characteristics of the mask. An MRMC study would be relevant for diagnostic imaging AI, where human readers interact with AI.
6. Standalone Performance
- The reported performance data (BFE, PFE, Differential Pressure, etc.) represents the standalone performance of the device itself, as measured by standardized laboratory methods. It's important to note that "standalone" in this context refers to the device's inherent physical properties, not an "algorithm only without human-in-the-loop performance" typical of AI devices.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is established by international and national standard test methodologies (e.g., ASTM F1862/F1862M-17, ASTM F2101-2019, ASTM F2299/F2299M-03, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the procedures and acceptance criteria for classifying the mask's performance.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical mask, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the manufacturing process would be ensuring the production consistently meets quality standards, which is demonstrated by the non-clinical tests on production samples.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI/ML device requiring a "training set" with established ground truth labels by experts. The performance is assessed against established engineering and safety standards.
Ask a specific question about this device
Page 1 of 1