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510(k) Data Aggregation
(287 days)
The Disposable surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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 proposed device is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
The provided text is a 510(k) summary for a disposable surgical face mask. It does not detail a study involving AI assistance for human readers or the establishment of ground truth by multiple experts for an AI device. Instead, it focuses on demonstrating substantial equivalence of the new medical device (a surgical mask) to a legally marketed predicate device through non-clinical performance testing and biocompatibility studies.
Therefore, most of the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI, and training/test set details for an AI model cannot be extracted from this document as it pertains to a different type of medical device evaluation.
However, I can provide information based on the performance testing of the surgical mask, interpreted as its "acceptance criteria" and "device performance".
Here's the information that can be extracted:
Device Acceptance Criteria and Performance (for a Disposable Surgical Face Mask)
The acceptance criteria and performance data are based on non-clinical testing against established standards for medical face masks and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable surgical face mask, Model: AD-PR02, AD-PR02-2, AD-PR02-S01, AD-PR02-S02 manufactured by Shandong Aida Medical Products Co., Ltd) was tested against the requirements for an ASTM F2100-2020 Level 2 classification mask.
| Characteristic | Acceptance Criteria (ASTM F2100-2020 Level 2) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | ≥ 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Yes |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass (specific value: 98.46%) | Yes |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.9% | Yes |
| Differential Pressure (Delta P) |
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