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510(k) Data Aggregation
(377 days)
The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical 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(s), provided non-sterile. For adult use.
The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier.
The provided document is a 510(k) summary for a surgical mask (Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01). It outlines the device's technical specifications and performance testing results to demonstrate substantial equivalence to a predicate device, rather than a study proving an AI/ML medical device meets acceptance criteria.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML clinical study (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document describes the physical and performance characteristics of a surgical mask, not the performance of an algorithm.
However, I can extract the acceptance criteria and performance data for the surgical mask based on the provided tables.
Acceptance Criteria and Device Performance (Surgical Mask)
| Item Tested | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| AA-US-SURGICAL-01 | ASTM F1862 | Fluid Resistance to Synthetic Blood | 160 mmHg | No penetration at 160 mmHg |
| AA-US-SURGICAL-01 | ASTM F2299 | Particulate Filtration Efficiency | >98% | Average 99.48% |
| AA-US-SURGICAL-01 | ASTM F2101 | Bacterial Filtration Efficiency | >98% | Average 99.4% |
| AA-US-SURGICAL-01 | ASTM F2100 | Differential Pressure |
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