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The xact™ foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal smallincision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.

The xact lens inserter (Model 6mm / 7mm) is a light weight plastic, single use, disposable device. It has a multi piece design, with an injector/handpiece unit and a separate cartridge.

The lens is delivered manually by action of the plunger. The final delivery is done by a screwthread action. The final injection needs 2- 3 turns with screw thread until the final position of the plunger. The plunger allows for forward and backward action during delivery. The front end of the plunger is visible during delivery.

The lens inserter (Model 6mm / 7mm) is for both handed use: one hand for gripping and directing, while activating the plunger with the other. The plunger doesn't rotate inside the handpiece.

The lens is rolled rather than folded. The cartridge or rolling/folding mechanism locks in place on the handpiece.

The provided text contains information about a 510(k) summary for the xact™ Injector, an intraocular lens inserter. However, it does not include the specific details required to answer your questions about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only states that:

"The xact™ lens inserter (Model 6mm / 7mm) has been tested in vitro for proper functioning under various conditions of use. The results of these performance tests demonstrate that the xact™ lens inserter (Model 6mm / 7mm) reliably delivers the Advanced Vision Science® 3-piece foldable lens without impacting the optical performance, the dimensions or the cosmetic appearance of the lens."

This statement confirms that performance tests were conducted and the device met certain functional requirements related to lens delivery and preservation of lens quality. However, it does not provide the specific "acceptance criteria" or the detailed "study" information requested.

Therefore, I cannot fill in the table or provide the specific details for the requested points based solely on the provided text. The document is a 510(k) summary, which often summarizes testing results without detailing the methodology or specific acceptance criteria in the public-facing document.

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