(58 days)
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 into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
Intramedullary rods are generally rod-shaped devices with or without screw holes at either end for fixation to bone. These devices are intended to be inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures by aligning and stabilizing the bone fragments. Intramedullary rods are also used to align and stabilize long bones which are surgically cut (osteotomy) to correct deformity. Additional stabilization may be realized by installing transverse screws through holes in the rod. Intramedullary rods and transverse screws are made of titanium 6Al-4V alloy.
This document is a 510(k) premarket notification for a medical device: Titanium Intramedullary Rods - Various Styles by Biomet, Inc.
Based on the provided text, the device is considered substantially equivalent to existing, legally marketed stainless steel intramedullary rods. This means that a specific study to prove new acceptance criteria for the titanium rods was likely not performed in the same way a new, novel device would be. Instead, the focus is on demonstrating that the new device (titanium) has the same function and overall design as a predicate device (stainless steel) that has a long history of safe and effective use.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this type of submission. However, I can infer and answer based on the nature of a 510(k) submission for substantial equivalence.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The provided summary does not outline specific numerical 'acceptance criteria' in the way a new device with novel performance claims would. For a 510(k) submission based on substantial equivalence, the primary "acceptance criterion" is that the device is as safe and effective as a legally marketed predicate device. The "reported device performance" is implicitly established by its equivalence to the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as presented in the 510(k)) |
|---|---|
| Safety and Effectiveness | "In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods which have been widely used for fracture fixation in long bones since the 1960s." |
| This statement directly asserts that the device meets the safety and effectiveness profile equivalent to established predicate devices. The discussion of potential risks (delayed/nonunion, bending/fracture, loosening/migration, metal sensitivity, limb shortening, pain, nerve damage, necrosis, infection, hematoma) acknowledges known risks common to any metallic internal fixation device, implying the titanium device shares these known risks and is not introducing new or more severe ones compared to the predicate. | |
| Biocompatibility (Implicit for medical implants) | The device is made of titanium 6Al-4V alloy. This material is well-established and widely used in medical implants, suggesting its biocompatibility is accepted and not a new challenge. The mention of "metal sensitivity, or allergic reaction to a foreign body" is a general potential risk, not specific to titanium over stainless steel as a new problem. |
| Mechanical Performance (Implicit, e.g., strength, durability) | The statement "In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods" implies that the mechanical properties (strength, resistance to bending/fracture) are comparable and suitable for their intended use. The potential risks like "Bending or fracture of the implant" are acknowledged as general risks for any such device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no explicit test set or sample size described for a study conducted on the Biomet Titanium Intramedullary Rods to prove acceptance criteria. This is typical for a 510(k) based on substantial equivalence to a predicate device with a long history of use. The "data provenance" for the predicate device's performance is its history of use since the 1960s, implying real-world, clinical data collected over decades, likely from various countries where it was used. This is generally retrospective and observational.
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. No specific "test set" and corresponding "ground truth" establishment by experts for the new device's performance is described in this 510(k) summary. The ground truth for the predicate device's safety and effectiveness is established through decades of widespread clinical use and acceptance by the medical community.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no explicit test set or specific performance study described for the titanium rods, no adjudication method would have been used.
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 device is a physical implant (intramedullary rod), not a diagnostic imaging device or an AI application that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptable performance and safety profile is effectively the long-term clinical outcomes data and expert consensus derived from the widespread and historical use of the predicate stainless steel intramedullary rods since the 1960s. The 510(k) argues that the titanium version functions the same way and is made of a known, safe material, hence it inherits this "ground truth" of established safety and effectiveness.
8. The sample size for the training set
Not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this type of device submission.
§ 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.