Search Results

The Plain 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. The face 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 Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask and with adjustable clips. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the acceptance criteria and the results of a study conducted for the AOK Tooling Limited's "Plain Surgical Face Mask" (K201517) to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Fluid Resistance (ASTM F1862): 32 samples (29 out of 32 passed).
• Flammability: 5 samples (5 of 5 showed no flame spread).
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure) and Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The exact sample size for these specific tests is not explicitly stated beyond stating "All the testing samples met the performance acceptance criteria" and "the device meets [ISO] requirements."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be a prospective evaluation of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: This document describes performance testing of a physical device (surgical face mask) against established industry standards (e.g., ASTM, ISO, CFR). The "ground truth" is determined by the objective results of these standardized tests, not by human expert interpretation.

4. Adjudication method for the test set:

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret data. For the objective performance testing described, the results are derived directly from laboratory measurements against specified criteria.

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 evaluation of a surgical face mask, not an AI-powered diagnostic device or an assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This document pertains to the performance evaluation of a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

• Objective Test Standards and Biocompatibility Assessments: The ground truth is defined by the objective pass/fail criteria outlined in recognized international and national standards such as ASTM F1862, 16 CFR Part 1610, ASTM F2299, ASTM F2101, ASTM F2100-9, EN 14683:2019, ISO 10993-5, and ISO 10993-10. These standards describe specific laboratory tests and their corresponding acceptance limits.

8. The sample size for the training set:

• Not Applicable: This document describes the testing of a manufactured medical device, not the development of an artificial intelligence model that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable: As there is no training set for an AI model, this question is not relevant to the provided document.

Ask a specific question about this device