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The Smart Correction System is indicated for pediations (excluding newborns) and adults for the following:

• · Joint contracture resulting in loss of range of motion.
• · Fractures and disease which generally may result in joint contractures or loss of range of motion.
• · Fractures requiring distraction.
• · Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
• · Correction of bony or soft tissue defects.
• · Correction of bony or soft tissue deformities.
• · Joint arthrodesis.
• Infected fractures or nonunions.
• · Limb Lengthening by epiphyseal or metaphyseal distraction.
• · Pseudoarthrosis of long bones.

The WishBone Medical Smart Correction System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the surgeon to adjust the position of the proximal and distal ring. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Correction System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steady, controlled fashion. In addition to the hardware, the Smart Correction System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images, and the fixator parameters into the software. Post operatively, the surgeon enters the X-ray images and the current frame parameters into the software to establish an adjustment schedule for the patient during the healing process.

The Smart Correction System is modular and facilitates a multitude of frame configurations to serve a wide variety of patient needs. Listed below are the high-level components and accessories:

• The fixator bridge is constructed of two (2) or more ring components, and each ring component is connected to another via six (6) telescopic struts. Full, 2/3, and 1/3 ring components are available, along with standard and rapid adjust struts in multiple lengths. Threaded rods are used as needed to provide added frame stability. Rings are manufactured from aluminum material; struts from titanium, stainless steel, and aluminum; and threaded rods are made from stainless steel material.
• The fixator bridge is anchored to the patient's bone by crossed tensioned wires and half pins that are secured to the rings by connector elements (wire clamps, pin clamps, cubes, bolts, nuts, and washers). Standard, olive wires, and threaded wires are available, as well as multiple diameters and styles of half pins. Pins and wires may also be used to secure fragments of bone and are made from stainless steel. Connector elements are manufactured out of titanium material. This submission also includes a line extension to add Hydroxyapatite (HA)-coated stainless steel Half Pin components.
• A foot ring is available and connected to the distal ring when a procedure such as ankle arthrodesis is performed. The foot rings are manufactured out of aluminum material.
• Patient comfort accessories are also included: strut ID clips (PETG), foot walking attachment (POM-C), and pin/wire caps (silicone, PVC) are also included.

The Smart Correction System includes reusable surgical instruments to facilitate surgical assembly of the fixator construct. The non-sterile implants and other fixator elements are contained within sterilization cases, along with the reusable instruments.

This document is an FDA 510(k) clearance letter for a medical device called the "Smart Correction System (HA Half Pins)". It primarily establishes substantial equivalence to a predicate device and does not involve AI assistance, image interpretation, or diagnostic performance evaluation that would typically require the requested information about acceptance criteria for AI/ML models.

Therefore, the requested information on acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment cannot be found in this document because the device in question is an external skeletal fixation system, not a diagnostic imaging AI.

The document discusses:

• Device identity: Smart Correction System (HA Half Pins)
• Regulatory information: Class II, Product Code KTT, Regulation 21 CFR 888.3030
• Intended Use and Indications for Use: For pediatric and adult patients for various orthopedic conditions like joint contractures, fractures, deformities, limb lengthening, etc.
• Substantial Equivalence: Claims equivalence to a predicate device (Smart Correction System K193368) based on intended use, indications for use, materials, design features, and sterilization.
• Performance Data: States that non-clinical testing (engineering analysis, construct stiffness, cleaning & sterilization validation, biocompatibility, HA coating characterization) was conducted in compliance with ASTM F1541-17.
• Clinical Testing: Explicitly states, "Clinical testing was not deemed necessary to demonstrate substantial equivalence."

Since the device is a mechanical orthopedic system and not an AI/ML-driven diagnostic tool, the concepts of "acceptance criteria for an AI model," "human readers improve with AI assistance," "standalone algorithm performance," "number of experts for ground truth," or "multi-reader multi-case studies" are not applicable to the information provided in this FDA clearance letter.

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