Search Results
Found 1 results
510(k) Data Aggregation
(124 days)
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. It 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 Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. 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 ear straps/ear loops are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Poly Ethylen. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
This document describes the acceptance criteria and the study proving a surgical face mask meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Purpose | Acceptance Criteria (Level 3, ASTM F2100-19) | Reported Device Performance | Result |
|---|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | Evaluate the Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.3-99.7% | Pass |
| Differential pressure (mmH2O/cm²) | Evaluate the Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 2.9-3.8 mmH2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | Evaluate the Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98 | 99.74-99.90% | Pass |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | Evaluate the Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 160mmHg | 32 of 32 test articles passed at 160mmHg | Pass |
| Flammability | Evaluate the Flammability | Class 1 | Class 1, Non Flammable | Pass |
| Cytotoxicity | Biocompatibility testing | Device is noncytotoxic | Device is noncytotoxic | Pass |
| Irritation | Biocompatibility testing | Device is nonirritating | Device is nonirritating | Pass |
| Sensitization | Biocompatibility testing | Device is nonsensitizing | Device is nonsensitizing | Pass |
2. Sample size used for the test set and the data provenance:
The document mentions "32 of 32 test articles" for the synthetic blood penetration test, implying a sample size of 32 units for that specific test. For other performance tests (BFE, differential pressure, PFE, flammability), specific sample sizes are not explicitly stated, but the results are reported as ranges or a single pass/fail, which typically implies multiple samples were tested to achieve these results.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the tests were conducted by the manufacturer, Hubei Qianjiang Kingphar Medical Material Co., Ltd, which is located in China. The study is a non-clinical test of the physical and chemical properties of the device, rather than a clinical study involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical performance and biocompatibility study of a medical device, not a study evaluating an AI or diagnostic tool where human experts establish ground truth. Therefore, the concept of "experts used to establish the ground truth" in that context is not applicable. The ground truth for these tests is defined by the recognized standards (ASTM F2100-19) and testing methodologies themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As a non-clinical performance and biocompatibility study, there is no adjudication method in the context of expert review or consensus building. The results are objectively measured against defined scientific and engineering 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:
Not applicable. This document pertains to the performance of a physical medical device (surgical face mask), not an AI or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth used for this study is based on recognized international standards and regulatory requirements, specifically:
- ASTM F2100-19 Level 3 for performance criteria (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability).
- Biocompatibility testing standards for Cytotoxicity, Irritation, and Sensitization (although specific standard numbers are not provided, these are generally covered by ISO 10993 series).
- Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
These standards define the objective criteria and methodologies against which the device's performance is measured.
8. The sample size for the training set:
Not applicable. This is a study to prove the performance of a physical medical device and does not involve machine learning or AI, hence there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant in this context.
Ask a specific question about this device
Page 1 of 1