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510(k) Data Aggregation
(127 days)
The Purism Disposable 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 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 Purism Disposable Surgical Masks are manufactured with 3 layers, the inner facing layer and outer facing layer are composed of non-woven fabric, the middle layer is made up of melt-blown fabric. The surgical masks are single use, flat-folded with ear loops. The 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 not made with natural rubber latex. The Surgical Masks are sold non-sterile and are intended to be disposable mask.
The provided document is an FDA 510(k) clearance letter for a medical device: "Purism Disposable Surgical Mask". This document does not describe an AI/ML-driven medical device, nor does it detail a study involving AI assistance for human readers or a standalone AI algorithm. It's a standard regulatory submission for a physical medical product (a surgical mask) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested items related to AI/ML device studies (such as MRMC studies, human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this document.
However, I can extract information related to the acceptance criteria and the study (non-clinical testing) that proves the device meets these criteria, as detailed in the document.
Here's the breakdown based on the provided text, addressing the applicable points:
Device Name: Purism Disposable Surgical Mask
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical apparel (21 CFR 878.4040)
Predicate Device: K182514 Disposable Surgical Face Mask (Xiantao Zhibo Non-woven Products Co., Ltd)
1. Table of Acceptance Criteria and Reported Device Performance
The document presents non-clinical performance testing and biocompatibility testing.
Non-Clinical Performance Testing:
| Performance Testing Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. | At least 29 out of 32 specimens per lot show passing results at 160 mmHg | 94 out of 96 pass at 160mmHg |
| Particulate Filtration Efficiency (PFE) ASTM F2299 | To determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. | ≥ 98% Average PFE for all samples tested | 96/96 Samples Pass at Average of 99.90% |
| Bacterial Filtration Efficiency (BFE) ASTM F2101 | To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. | ≥ 98% Average BFE for all samples tested | 96/96 Samples Pass at Average of 99.88% |
| Differential Pressure (Delta P) EN 14683 | To determine the pressure required to breathe through the final manufactured face mask. | Samples must be |
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