(128 days)
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
The In2Bones Fracture and Correction System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The scope of this submission is to add smaller diameter CoLag™ Screws as well as a version of all lag screws within the system that has a modified tip design. All screws are manufactured from Titanium Alloy conforming to ASTM F136.
The provided document is a 510(k) summary for the In2Bones Fracture and Correction System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through direct comparison of indications, materials, and geometry, as well as performance testing.
Crucially, this document describes a traditional medical device (bone fixation system) and not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The document demonstrates equivalence based on:
- Indications for Use: The subject device has similar intended uses for treating fractures, fusions, osteotomies, and non-unions of various bones, aligning with its predicate devices.
- Material: The device is made of Titanium Alloy (ASTM F136), which is consistent with the primary predicate and some additional predicates. One predicate uses Stainless Steel, but the overall material conformity is deemed acceptable.
- Geometry and Dimensions: The subject device introduces smaller diameter CoLag™ Screws and a modified tip design but remains within the range of dimensions and geometries of the predicate devices.
- Performance Testing: Non-clinical tests were conducted:
- Insertion/Removal Testing
- Static Pull-out Testing
- Torque Capacity Testing (per ASTM F543)
These tests confirmed that the subject device performs substantially equivalently to the predicate.
Therefore, I cannot provide the requested information about AI/ML acceptance criteria and study details because the provided text describes a physical medical device clearance, not an AI/ML device.
If you have a document pertaining to an AI/ML medical device, please provide it, and I will gladly describe its acceptance criteria and study details based on that information.
§ 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.