(29 days)
The DePuy ACE® Universal and Troch Entry Femoral Nail System is 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 fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric 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 DePuy ACE® Universal Nail is a revision of the ACE® AIM Femoral Nail (K871539). The Universal Nail is a slightly bowed intramedullary nail with proximal holes and distal lateral / medial holes and anterior/ posterior holes. The nail is "universal" in design, as it requires no right or left device configurations. It is designed to be inserted in either an antegrade or retrograde approach. The nail sizes include 8mm through 15mm diameters and lengths of 280mm through 500mm.
The Troch Entry Nail (TEN) is similar in design to the ACE® Trochanteric Nail System (K010780) and the ACE® Long Trochanteric Nail System (K013563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with proximal and distal holes. It is intended for antegrade insertion only. This nail includes a small proximal bend for insertion just lateral to the tip of the greater trochanter. Due to this bend, the nail designs require a right and left anatomic version. This nail system includes 9mm, 11mm and 13mm diameters in lengths of 280mm through 500mm in right and left versions.
The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).
The medical device being described is the DePuy ACE® Universal and Troch Entry Femoral Nail System, an intramedullary rod used for bone fixation. Based on the provided text, the submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through clinical studies.
Therefore, the document does not contain information related to specific acceptance criteria or a study designed to prove the device meets such criteria.
Here’s why and what information is available:
- Substantial Equivalence (510(k) pathway): The FDA’s letter clearly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device's safety and effectiveness are established by demonstrating it is as safe and effective as a legally marketed predicate device, not by meeting new, specific performance acceptance criteria through a dedicated study for that purpose.
- Lack of Performance Study Details: The document does not describe any clinical or non-clinical study that would generate "reported device performance" against predefined "acceptance criteria." There are no sections detailing sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, the full table and subsequent detailed questions about a performance study cannot be answered from the provided text.
Here is the information that can be extracted or inferred from the provided text, related to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| (The approval is based on substantial equivalence to predicate devices, not on meeting new specific acceptance criteria through a performance study described here.) | (The document does not provide details of a specific device performance study or its results.) |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/Not provided. No test set for a performance study is described.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No ground truth establishment for a test set is described.
4. Adjudication method for the test set
- Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- Not applicable/Not provided. This device is an intramedullary rod, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not applicable/Not provided. This device is an intramedullary rod, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided.
8. The sample size for the training set
- Not applicable/Not provided. This device is an intramedullary rod, not an AI/algorithm product requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary: The provided document is a 510(k) premarket notification for an intramedullary rod system, where FDA approval is granted based on substantial equivalence to existing predicate devices. It does not contain the details of a performance study with acceptance criteria, sample sizes, expert ground truth, or other elements typically found in submissions for novel diagnostic algorithms or devices requiring de novo performance evaluation.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.