(28 days)
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:
- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, mal-union and delayed union
- Periprosthetic fractures
- Surgically created defects such as osteotomies
- Intertrochanteric and subtrochanteric fractures
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include:
- Compound and simple shaft fractures
- Proximal, metaphyseal, and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
- Severely comminuted supracondylar fractures with articular involvement
- Fractures involving femoral condyles
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, and mal-union
- Periprosthetic fractures
- Poly trauma patients
The Zimmer Natural Nail System is a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet the assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are made of Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.
This K172114 Premarket Notification for the Zimmer Natural Nail System (specifically 6.0mm Fixed Angle Screws) primarily focuses on demonstrating substantial equivalence through mechanical testing data rather than on AI/ML algorithm performance. Therefore, many of the requested data points related to AI/ML studies are not applicable or cannot be extracted from this document.
However, I can provide the information that is present concerning the device's performance through non-clinical testing.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "new mechanical testing data for the Zimmer Natural Nail System - 6.0mm Fixed Angle Screws... is different than the performance specifications submitted in the original premarket notifications." This implies that performance data was collected and compared to established specifications from the predicate devices, but the specifics are not provided in this summary.
The non-clinical tests performed were:
- Screw Three Point Bend Test
- Proximal Nail Fatigue Construct Test
- Distal Nail Fatigue Construct Test
The document states, "Testing has been performed to establish product non-pyrogenicity" which is a biological safety characteristic, not a performance metric in the same vein as mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the mechanical tests performed (e.g., number of screws, nails tested).
The provenance of the data is not explicitly stated beyond being collected for this premarket notification. It can be inferred to be prospective testing conducted by Zimmer Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This document describes mechanical testing of a medical device, not an algorithm that requires a ground truth established by human experts.
4. Adjudication Method for the Test Set
Not applicable. This document describes mechanical testing of a medical device, not an algorithm that requires an adjudication method for human expert review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document pertains to the mechanical performance of an orthopedic implant, not an AI/ML diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This document pertains to the mechanical performance of an orthopedic implant, not an AI/ML algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established mechanical performance specifications or industry standards against which the device was tested. The document implies that new mechanical testing data was gathered and compared to the performance specifications of the predicate devices. Specific standards (e.g., ISO, ASTM) are not cited in this summary, but these would typically form the basis of such "ground truth" for mechanical testing.
8. Sample Size for the Training Set
Not applicable. This document pertains to mechanical testing of a physical medical device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device's mechanical testing.
In summary, this 510(k) pertains to a traditional medical device (intramedullary fixation system) and its mechanical performance, not an AI/ML enabled device. Therefore, the information typically requested for AI/ML device studies (such as expert consensus, test set/training set details, MRMC studies) is not present in this document. The "study" described herein involves non-clinical mechanical testing, with the aim of demonstrating that the new mechanical data results in substantial equivalence to the predicate devices.
§ 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.