Search Results

The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).

The InCore® Subtalar System consists of a post and two headless compression screws. Posts are available with an 8.0 mm diameter, in an 28mm length, and in right and left orientations. Screws are available in a 5.5 mm diameter and lengths of 50 to 120mm. The post is inserted into the talus and compression screws are inserted into the calcaneus 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 system is provided with a set of accessory instruments, including an implant specific targeting guide, designed for preparation of the implant site and insertion of the implants into bone.

The provided text describes a 510(k) premarket notification for a medical device called the InCore® Subtalar System. This document does not include information about AI/ML device performance, acceptance criteria for an algorithm, or a study that proves a device meets such criteria.

The information provided is typical for a medical device clearance, focusing on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
• Device Description and Intended Use: What the device is and what it's used for (internal fixation of bone arthrodeses, osteotomies, and nonunions in the foot, specifically subtalar joint arthrodesis).
• Non-Clinical Testing: Mechanical and biocompatibility tests (e.g., torque to failure, three-point bend tests, endotoxin testing) to ensure the device's physical properties and safety.
• Clinical Testing: The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Subtalar System to the predicate device." This means no human clinical trials were conducted for this submission.

Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML study performance, sample sizes, expert involvement, or ground truth establishment for an AI/ML device from this document. The device described is a physical implant (bone screw system), not an AI algorithm.

Ask a specific question about this device