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The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).

The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136.

The current submission adds disposable instruments to the InCore® Lapidus System. The disposable instruments are packaged in sterile kits with the 28mm post and post plug screw implant. The implant components of the system are unchanged aside from the change in packaging of the 28mm posts and post plug screws.

This is a 510(k) premarket notification for a medical device called "InCore® Lapidus Sterile Kits". Based on the provided text, the device is a bone fixation fastener used for First Metatarsocuneiform arthrodesis. The document states that clinical testing was not necessary to demonstrate substantial equivalence, meaning a study proving the device meets acceptance criteria as typically understood for AI/ML devices or clinical trials was not conducted or required.

The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change from re-usable, non-sterile instruments to disposable, sterile instruments packaged with the implants.

Therefore, the requested information cannot be fully provided in the context of a typical acceptance criteria study for device performance (e.g., sensitivity, specificity, accuracy). However, I can extract the relevant information from the document regarding the non-clinical testing performed to support the substantial equivalence claim for the instrument change.

Here's an adaptation of the requested information based on the provided 510(k) summary:

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

Since this is a substantial equivalence submission primarily for a change in instruments and packaging, the "acceptance criteria" are related to biocompatibility, sterility, and endotoxin levels for the new disposable instruments and packaging, rather than clinical performance metrics. The document implies acceptable results for these non-clinical tests.

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