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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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