Search Results

The Titanium Retrograde Femoral Nail is indicated for internal fixation and stabilization of the femur. These devices are implanted by insertion into the medullary canal of the femur for fixation of open and closed acute distal femoral fractures, pathological fractures, malunions, nonunions, failed plate/screw osteosyntheses of the distal femur, fractures proximal to a total knee arthroplasty, fractures distal to a total hip prosthesis, and fixation of a surgically prepared femur (osteotomy) for correction of deformity.

Femoral nails are to be used for treatment of fractures of the femur including: non-I enoral natis and comminuted mid-shaft fracture, subtrochanteric fracture, distal third comminuted and commination mid bither fransal neck, intertrochanteric fracture, fracture, combination fractures of the mochanteric fractures. Other indications include: combination interactive procedures following tumor resection, and revision procedures where other treatments or devices have failed.

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These 13 mm diameter nails have the same intended use, warnings and precautions as those nails previously cleared in K982953. A new 13 mm size is being added in 20cm, 24cm, 28cm, 32cm, 34cm, 36cm, 38cm, 40cm and 44cm lengths to expand the product line. The 13 mm diameter is larger than the retrograde style nails previously cleared.

This appears to be a 510(k) premarket notification for a medical device, specifically a Titanium Retrograde Femoral Nail. The provided documents describe the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would be relevant for a machine learning or diagnostic device.

The 510(k) pathway for traditional medical devices (like this intramedullary nail) typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new performance studies with acceptance criteria in the same manner as a novel diagnostic or AI device. The "Summary of Safety and Effectiveness" here focuses on the material, design similarity, and intended use compared to existing devices.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable to the provided text. I will address each point based on the information available and note when information is not present or not relevant to this type of submission.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on substantial equivalence to a predicate device rather than a new clinical performance study with a test set. There is no new data provenance or sample size reported for the performance of this specific device model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth assessment by experts for a test set is not part of this 510(k) submission type. The "ground truth" for predicate devices is established through their long-standing use and clinical acceptance over decades.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process described in this submission.

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. This is a medical implant, not an AI or diagnostic device that involves human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the predicate devices, the "ground truth" for safety and effectiveness is implicitly established through decades of clinical use and physician experience with intramedullary rods for fracture fixation. No specific new ground truth for this device is established beyond its material and design similarity to existing devices. The submission states, "This device utilizes standard technology that is commonly known by physicians."

8. The sample size for the training set

Not applicable. This is a medical implant, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This is a medical implant, not a machine learning model.

Summary of Device and Approval Context:

The Titanium Retrograde Femoral Nail - 13 MM Diameter is an intramedullary rod used for internal fixation and stabilization of the femur in various fracture scenarios. The 510(k) clearance (K013923) was granted based on the device's substantial equivalence to previously cleared Biomet Titanium Intramedullary Nails (K982953), which themselves were equivalent to devices commercially available since the 1950s. This means the device met the regulatory requirements by demonstrating that its technology, intended use, and fundamental safety and effectiveness profiles are similar to devices already on the market. The FDA determined that no new premarket approval application (PMA) was required because the device does not raise new questions of safety and effectiveness.

Ask a specific question about this device