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The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

This document is about the regulatory approval of a medical device, the OrthoHelix™ Staple System, and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification decision letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: OrthoHelix™ Staple System
• Indications for Use: Fixation in the hand and foot (fractures, fusions, and osteotomies).
• Regulatory Class: Class II
• Material Composition: Nickel Titanium Alloy

The basis for substantial equivalence included:

• Engineering calculations
• Finite element analysis
• Mechanical bending and pullout tests (per ASTM F564)
• Corrosion testing (per ASTM F2129)

These are standard engineering and material science tests for a physical medical implant, not performance criteria or a validation study for an AI/ML device. Therefore, none of the specific information requested about acceptance criteria, study design, sample sizes, expert involvement, or ground truth is present in the provided text.

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The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

The provided text describes a medical device, the OrthoHelix™ Staple System, and its clearance process with the FDA. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) performance evaluation.

The document is a 510(k) summary and an FDA clearance letter for a Class II medical device (bone staple). The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering calculations, finite element analysis, and mechanical/corrosion testing. This type of submission generally does not involve clinical performance studies with human subjects or AI-based analyses.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details, as this information is not present in the provided text.

Ask a specific question about this device