Search Results

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are 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 nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.

This appears to be a 510(k) summary for a medical device (Osteo IC Retrograde/Antegrade Femoral Nail - Accessories), specifically focusing on a nut and washer component.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity, or any clinical outcomes). The document is a premarket notification for substantial equivalence, which primarily addresses device design, materials, and intended use in comparison to a predicate device.

Let's break down why the requested information cannot be provided from this text:

1. A table of acceptance criteria and the reported device performance: This document explicitly states, "The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail." Substantial equivalence is the pathway being used here, not a performance study against predefined criteria. No performance criteria (e.g., strength, durability, biocompatibility) or reported performance against such criteria are present in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described. The focus is on demonstrating equivalence based on design and materials.
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, as no test set requiring ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is mentioned.
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 mechanical orthopedic implant (nut and washer), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for performance evaluation in this document.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

In summary, the provided text is a 510(k) Pre-Market Notification Summary for substantial equivalence of a medical device (an orthopedic nut and washer), not a clinical or performance study report. Therefore, it does not contain the information requested regarding acceptance criteria and device performance studies commonly associated with diagnostic or AI-powered devices. The "proof" here is the assertion of substantial equivalence to a legally marketed predicate device based on design, materials, and intended use, which the FDA has accepted.

Ask a specific question about this device

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.

Ask a specific question about this device