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510(k) Data Aggregation
(170 days)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective 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 Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.
This document is an FDA 510(k) premarket notification for a medical protective mask. It does not describe an AI medical device or an MRMC study. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI and human reader improvement, cannot be extracted from this document.
However, I can provide the acceptance criteria and reported performance for the physical and biological characteristics of the medical protective mask based on the provided text.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This table details the performance criteria for the Medical Protective Mask (Model: KF-A F02(N)) based on ASTM F2100 Level 2 standards.
| Title of the test | Acceptance criteria | Reported Device Performance | Verdict |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ≥ 98% | 99.1% | Pass |
| Differential pressure (Delta-P) | < 6.0 mm H2O/cm² | On average of 5.04 mm H2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres (PFE) | ≥ 98% | 99.9% | Pass |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 120 mm Hg | Fluid Resistant claimed at 120 mm Hg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |
| Shelf-life | Meets the requirements of ASTM F2100 level 2 after 2 years of accelerated aging | Pass | Pass |
| In vitro Cytotoxicity Test | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Determined to be non-cytotoxic. | Pass |
| Skin Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Determined to be non-irritating. | Pass |
Information Not Applicable or Not Found in the Document:
The provided document is a 510(k) premarket notification for a Medical Protective Mask, which is a physical device, not an AI/software-based medical device. Therefore, the following points related to AI, imaging, and clinical studies are not applicable or not found in this document:
- Sample size used for the test set and the data provenance: Not applicable for this type of device and testing. The performance tests are laboratory-based, often using standard samples or methods (e.g., bacterial aerosols, synthetic blood).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for masks is established by standardized laboratory test methods, not expert clinical interpretation.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation, not mask performance. The document explicitly states "No clinical study is included in this submission."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on standardized laboratory test methods and established measurement criteria (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862 for fluid resistance, ISO 10993 for biocompatibility).
- The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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