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The DePuy Opti-Con and E-Z Shield Systems are intended as face shields to be worn by operating room personnel during surgical procedures to provide splash protect the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Opti-Con Shields, E-Z Shield and Opti-Con goggles are intended to be disposable. The Opti-Con head gear is intended to be reusable.

The Opti-Con Faceshield System consists of a disposable faceshield which is designed to provide splash protection to the wearer's eves, nose, mouth and ears during surgical procedures and re-usable headgear which fits over the top of the head and holds the faceshield in place. The disposable faceshields are manufactured from polycarbonate and are available in a standard and a long length, either sterile or nonsterile. The Opti-Con Faceshields are substantially equivalent to the Splash Shields in that they have similar designs and the same intended use. Impact testing of both designs demonstrates that the impact resistance of the Opti-Con Shields is greater than that of the Splash Shields.

The E-Z Shield is a one-piece disposable faceshield and headband which is also designed to provide splash protection to the wearer's eyes, nose, mouth and ears during surgical procedures. The E-Z Shield is identical to the Splash Shield Splash Shield but is relabeled by DePuy. The E-Z Shield is manufactured from PETG as is the faceshield of the DePuy Disposable Filter/Hood.

The Opti-Con goggles are disposable goggles designed to protect the eyes during surgical procedures. They are substantially equivalent to the DePuy Shades Protective Glasses in that they have similar designs, the same intended use, and both are manufactured from polycarbonate.

This 510(k) premarket notification describes a physical medical device (surgical facesheilds), not an AI/ML-driven device. As such, the input requested (acceptance criteria, study details, ground truth, etc., typically associated with AI/ML performance evaluation) is not applicable to this document.

The document discusses substantial equivalence to predicate devices based on design, intended use, and materials. It also mentions "impact testing," which would be a physical performance test for the face shield's protective capabilities.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation.

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