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The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.

The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.

This submission is a modification of the currently marketed Alta IM rods and cap screws cleared under various 510(k) notifications. The new femoral IM rods will have proximal and distal holes for dynamic or static locking. There will also be a dynamic slot design for dynamic locking. They will be available in various configurations including round and fluted designs, solid or cannulated rods in diameters ranging from 9mm to 14 mm in various lengths. A new cap screw will be available with extended ends. These new components will be used with cross-locking screws and other rod components previously cleared under different premarket notifications.

This document appears to be a 510(k) summary and an FDA clearance letter for a medical device, specifically the ALTA® A-P Rod Modification (Retrograde Rod System) for intramedullary nailing of femoral, tibial, and humeral fractures.

Based on the provided text, there is no acceptance criteria or study data present that describes performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance. This type of information is not typically included in a 510(k) summary for a device seeking substantial equivalence based on predicate devices.

The 510(k) process for this type of device (intramedullary fixation rods) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, materials, design, and operational principles, rather than presenting new clinical performance data from a specific study against a set of acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, expert qualifications, or ground truth methods from the provided text.

The closest relevant information is:

• Intended Use: Stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur.
• Substantial Equivalence: Based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Alta® IM Rod System, Synthes' Ti DFN System, and ACE Medical's ART™ Femoral Nail System.

If this were a submission for a device requiring performance data (e.g., a software as a medical device or a novel diagnostic), this information would be explicitly detailed. However, for this type of hardware modification, the focus is on demonstrating that the new modification does not raise new questions of safety or effectiveness compared to legally marketed predicate devices.

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