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The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

• Raw materials
• Manufacturing processes
• Sterilization procedures
• Nature of body contact
• Design and function

The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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The Afghan External Fixator and its components are intended to be used in adolescents (12-21 years) and adults for securing small bone fractures and bone fragments on non-long bones including: patella and olecranon.

Components in the Afghan External Fixator are for single use only.

Subject of this premarket notification is the Afghan External Fixator. The Afghan External Fixator is a unilateral external fixation system that offers specially designed components used in the management of small bone fractures. System components include male and female struts (or frame) and nuts made from stainless steel material. Like the predicate devices listed below, the subject components are used in conjunction with Kirschner wires to provide a device customized to meet specific patient needs.

The provided text describes a medical device submission (K092002 for the Afghan External Fixator) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets specific acceptance criteria through a clinical study or comprehensive performance testing against predefined metrics.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document because it is not a performance study report.

This 510(k) summary primarily addresses:

• Device Description: The Afghan External Fixator is a unilateral external fixation system for small bone fractures.
• Intended Use: For adolescents (12-21 years) and adults to secure small bone fragments on non-long bones (patella and olecranon).
• Technological Characteristics: Similar to predicate devices in materials and characteristics.
• Substantial Equivalence: Based on similarities in design features and indications for use with identified predicate devices (Osteo Kirschner Wires, Smith & Nephew Kirschner Wires, Smith & Nephew External Fixation System Unilateral & Multilateral Fixators and Accessories).

There is no mention of:

• Specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, mechanical strength thresholds).
• A formal study to prove the device meets such criteria.
• Sample sizes for a test set or training set.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC studies or AI performance.
• Standalone algorithm performance.
• Types of ground truth (pathology, outcomes data, etc.).

In summary, the provided document is not a study report demonstrating acceptance criteria; it is a regulatory submission for substantial equivalence.

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