Search Results

The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask and dental face mask.

Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transms, bodily fluids and particulate material.

The Cross Protection® ResQ300 Plus Surgical Facemask is a pleated, multi-ply design, which is a nonsterile, single use, disposable device. The mask covers the nose and mouth and is secured to the face using the attached ear loops or attached ties.

The outer layer is made of 100% blue spun-bond polypropylene. The middle layer is filter media composed of 100% white melt-blown polypropylene. The inner (patient contacting) layer is made of either 100% white spun-bond polypropylene or 100% white medical grade tissue paper.

The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.

The nosepiece is made of malleable aluminum.

All materials used in the construction of the mask are being used in currently marketed devices.

Here's a breakdown of the acceptance criteria and study information for the Cross Protection ResQ300 Plus Surgical Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., how many masks were tested for BFE, PFE). However, the testing conducted is non-clinical bench testing, which means it does not involve human subjects or patient data. The provenance of the data is from laboratory testing performed according to the specified international and national standards (ISO, ASTM, EN, CFR).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the ground truth for this device (a surgical face mask) is established through standardized laboratory testing against objective performance criteria, not through expert human interpretation or consensus. The test results themselves serve as the 'ground truth' against the defined acceptance criteria.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the evaluation relies on objective laboratory measurements and does not involve human interpretation or adjudication processes like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. This submission is for a surgical face mask, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance with human readers is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. As explained above, this device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and objective laboratory measurements. For instance, the Bacterial Filtration Efficiency (BFE) is a measured percentage, and flammability is classified according to a specific standard. The results of these tests against predefined acceptance criteria from the standards constitute the "ground truth" for evaluating the mask's performance.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for a physical surgical face mask.

Ask a specific question about this device