(185 days)
The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
The Revolution Femoral Intramedullary Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The Revolution Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The Nail is available in a variety of diameters and lengths.
Locking screws are also included as a component of the Nail system. The locking screws are designed to reduce the likelihood of shortening and rotation of femoral fractures. The locking screws are available in a single diameter and a variety of lengths.
The ancillary instrumentation include standard orthopedic instruments for accessing the femoral medullary canal, preparing the bone for placement and installation of the intramedullary nail and locking screws, and removal of the intramedullary nail and screws, if required.
Here's an analysis of the provided text regarding the Revolution Femoral Intramedullary Nail System, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification for a medical device. It does not contain the detailed study information typically found for AI/ML-based devices regarding acceptance criteria, sample sizes, expert ground truth, or MRMC studies. The device, an intramedullary nail system, is a traditional orthopedic implant, not an AI/ML-powered diagnostic or treatment planning system. Therefore, the questions related to AI/ML device evaluation are not applicable to this submission.
The "studies" described are non-clinical, meaning they involve engineering testing rather than human clinical trials or data analysis.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria or detailed reported device performance metrics in the format usually expected for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and performance as intended | "Results of testing confirm that the Revolution Femoral Intramedullary Nail System reliably performs as intended." |
| Substantial equivalence to predicate devices | "Revolution Femoral Intramedullary Nail System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics." |
| No new questions of safety or effectiveness | "No new questions of safety or effectiveness have been raised." |
| Compliance with non-clinical testing requirements | "The safety and performance... have been substantiated through non-clinical testing." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided for this type of device submission. The device is a physical implant. The "test set" would refer to the number of nails or components tested in non-clinical (e.g., mechanical) studies, which is not detailed here. There is no "data provenance" in the context of clinical images or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device. There is no "ground truth" established by clinical experts in the context of device performance in non-clinical testing.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations of clinical data, which is not the subject of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This information is not applicable to this device. An MRMC study is relevant for AI-assisted diagnostic or interpretation systems. This is a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable to this device. A standalone study refers to the performance of an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Revolution Femoral Intramedullary Nail System's performance is implicitly defined by engineering specifications, material properties, and comparison to legally marketed predicate devices. The testing would likely involve mechanical stress tests, fatigue tests, and material characterization to ensure the device meets predefined physical and performance standards comparable to existing implants. It is not based on expert consensus, pathology, or outcomes data in the sense of clinical study results for a diagnostic or predictive algorithm.
8. The Sample Size for the Training Set
This information is not applicable to this device. There is no "training set" in the context of machine learning for a physical orthopedic implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device.
§ 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.