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510(k) Data Aggregation
(29 days)
Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric / intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trohchanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.
The Universal and Troch Entry Femoral Nailing Systems Line Extension offers an additional 5mm distal screw, 20-80mm. The system consists of Universal and Troch Entry nails for femoral fracture fixation. The titanium nails range in diameter from 9 - 15mm and lengths of 280 - 500mm.
This document describes the 510(k) summary for the DePuy Orthopaedics, Inc. Universal and Troch Entry Femoral Nailing Systems Line Extension. The device is an intramedullary fixation rod and accessories intended to treat various femoral fractures and conditions.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| 5mm screws perform equivalently to predicate devices | Successfully met pre-determined acceptance criteria |
| Dimensional analysis similar to predicate devices | Similar to predicate devices |
| Torque testing similar to predicate devices | Performed equivalently to predicate devices |
| Bend testing similar to predicate devices | Performed equivalently to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "bench testing" was performed to confirm substantial equivalence. No information is provided regarding human test subjects or clinical data, thus no sample size for a "test set" in the context of clinical studies, nor data provenance (e.g., country of origin, retrospective/prospective), is applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The study involved bench testing of the device's physical and mechanical properties, not an evaluation of clinical performance requiring expert ground truth in a medical context.
4. Adjudication Method for the Test Set:
This information is not applicable, as the study involves bench testing of mechanical properties, not human judgment or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The study presented here is a 510(k) submission focused on demonstrating substantial equivalence through bench testing, not a clinical effectiveness study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This concept is not applicable to the device described. This device is a medical implant (intramedullary fixation rod), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation was based on engineering and material science principles, specifically the established performance characteristics and dimensional profiles of already marketed predicate devices. The new 5mm screws were compared against these known, accepted standards.
8. The Sample Size for the Training Set:
This information is not applicable. This device is a physical medical device, not an AI or algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
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