(26 days)
The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.
The provided text is for a 510(k) premarket notification for "Mini Fragment Plates", a type of orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies.
Therefore, the requested information, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, are not present in the provided document.
Instead, the document details:
- Device Name: Mini Fragment Plates
- Manufacturer: Hand Innovations, LLC
- Predicate Device: Fragment Plate System (K041081)
- Classification: Class II
- Indications for Use: Stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
- Device Description: Orthopedic plates and fasteners (Straight, Y, Right Hockey Stick, Left Hockey Stick), pegs, screws, K-wires, reusable instruments (peg drivers, standard surgical tools), and non-reusable instruments (F.A.S.T. Guide Technology™ Drill Guide, drill bits).
- Biocompatibility: Not required as the material (Ti-6Al-4V ELI per ASTM F 136-00) is the same as the previously approved predicate device and has a long history of safe use.
- Summary of Substantial Equivalence: The proposed Mini Fragment Plates have the same indications for use, intended use, basic shape/design, operating principle, and materials as the predicate device. The changes do not alter the fundamental scientific technology.
This document is a regulatory submission focused on confirming that the new device is "substantially equivalent" to an already approved device, meaning it doesn't raise new questions of safety and effectiveness. It does not involve performance testing against specific clinical or system-level acceptance criteria in the way a novel diagnostic or AI-driven device would.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.