(49 days)
The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures.
- Pseudarthrosis and correction osteotomy.
- Pathologic fractures, impending pathologic fractures, and tumor resections.
- Supracondylar fractures, including those with intra-articular extension.
- Ipsilateral femur/tibia fractures.
- Fractures proximal to a total knee arthroplasty.
- Fractures distal to a hip implant.
- Nonunions and malunions.
The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Osteo IC Retrograde/Antegrade Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Osteo IC Retrograde / Antegrade Femoral Nail is available in three versions, each in lengths from 240mm to 500mm in 20mm increments, and in diameters from ø9mm to ø15mm in 1mm increments. A compression screw and locking screw may be used with the Femoral Nail. An end screw and an end cap are also available for use with the Femoral Nail. An end cap or end screw is used if a compression screw has not been used. The end screw is used when the Femoral Nail has been inserted via a retrograde approach. The end cap is used when the Femoral Nail has been inserted via an antegrade approach.
This is a 510(k) premarket notification for a medical device (Osteo IC Retrograde/Antegrade Femoral Nail), not an AI/ML clinical study. Therefore, the requested information about acceptance criteria, study design, and AI/ML specific details is not applicable to this document.
Here's why and what information can be extracted:
- No Acceptance Criteria or Device Performance Study: 510(k) submissions for devices like this typically focus on demonstrating substantial equivalence to a predicate device already on the market, not on conducting a new clinical study with specific performance metrics and acceptance criteria for a novel technology.
- No AI/ML Component: The device is a physical intramedullary nail for fracture fixation. There is no mention of any AI or software component in the submission.
- No "Test Set," "Training Set," or "Ground Truth": These terms are relevant to AI/ML model development and validation. Since this is a physical medical device, these concepts do not apply.
- No "Experts" for Ground Truth (in the AI/ML sense): While medical professionals like surgeons and radiologists use such devices, their role isn't to establish "ground truth" for an AI model's output in this context.
- No "MRMC Comparative Effectiveness Study": This type of study assesses how AI assistance impacts human reader performance, which is irrelevant for a standalone physical implant.
Information that can be extracted from the document (though not matching your specific table format for AI/ML):
Summary of Device and Regulatory Status:
- Device Name: Osteo IC Retrograde/Antegrade Femoral Nail
- Sponsor: Osteonics Corporation
- Submission Date: July 22, 1998
- FDA Decision Date: September 14, 1998
- Regulatory Class: II
- Product Code: HSB
- Predicate Devices: Synthes Titanium Distal Femoral System, Synthes Titanium Unreamed Femoral Nail System, AIM Titanium Femoral Nail (ACE Medical), Richards Retrograde Nail.
- Determination: Substantially Equivalent to predicate devices.
- Device Description: Cylindrical, cannulated titanium alloy tube, slightly bowed, available in various lengths (240mm to 500mm) and diameters (ø9mm to ø15mm). Can be inserted via retrograde or antegrade surgical approaches. Uses locking screws, end caps, nuts, and washers.
- Intended Use/Indications: Long bone fracture fixation, specifically femoral fracture fixation, including:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur/tibia fractures
- Fractures proximal to a total knee arthroplasty
- Fractures distal to a hip implant
- Nonunions and malunions
This document is a regulatory filing for a conventional medical device, not a study report for an AI-powered diagnostic or therapeutic tool.
§ 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.