(103 days)
The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/ 3rd Tarsometatarsal Fusion).
The InCore® TMT System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the cuneiform and compression screws are inserted into the 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 system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
The provided document is an FDA 510(k) Premarket Notification review letter and associated summary for the Nextremity Solutions InCore® TMT System. This document focuses on demonstrating substantial equivalence to predicate devices for a bone fixation fastener, not on assessing the performance of an AI/ML-based device.
Therefore, the information required to answer your questions about acceptance criteria and a study proving an AI/ML device meets those criteria (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.
Specifically, the document states:
- "Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® TMT System to the predicate device." This explicitly confirms that a clinical study, which would typically contain the performance data you're asking about, was not performed or required for this submission.
- The non-clinical testing mentioned (endotoxin testing, axial pull-out strength, torque to failure, 3-point bend tests) are mechanical and material property tests to ensure the device itself is robust, not to evaluate the performance of an AI model.
In summary, this document does not describe an AI/ML device, nor does it contain the kind of study data you are asking for. It pertains to a physical medical device (a bone screw system) and its mechanical performance relative to similar existing devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.