FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: 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.

Device Description

The Zimmer Natural Nail System Tibial Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The intramedullary nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and extend the length of the nail. All components are made of TI-6AL-4V alloy material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zimmer® Natural Nail™ System Tibial Nail. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria.

Therefore, the document explicitly states: "Clinical data and conclusions were not needed for this device." This means that many of the requested elements for a study proving device performance against acceptance criteria are not applicable or available in this submission.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not applicable due to the nature of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Not Applicable in this 510(k) submission for clinical performance.
The device's safety and effectiveness were demonstrated through non-clinical (lab) performance testing and by showing substantial equivalence to predicate devices, not by meeting specific clinical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable for clinical performance testing.
No human-based "test set" for clinical data was used or described. The submission is based on non-clinical (lab) testing and comparison to predicate devices.

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.
Since no clinical test set was used to assess performance against a ground truth, no experts were needed for this purpose.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable.
No clinical test set requiring adjudication was 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 an intramedullary nail for fracture fixation, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable.
This device is a physical medical implant, not an algorithm or software-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable for clinical performance.
For the non-clinical lab testing, the "ground truth" would be engineering specifications and accepted standards for mechanical properties and material science.

8. The sample size for the training set

Not Applicable.
As this is not an AI/machine learning device, there is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable.
No training set was used.

Summary of Device Performance and Basis for Clearance (Extracted from the Text):

The Zimmer® Natural Nail™ System Tibial Nail was cleared based on:

Non-Clinical Performance: The results of "non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
Substantial Equivalence: The device is considered "similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices."
- Predicate Devices:
  - Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)
  - Sirus® Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, cleared January 31, 2005)
  - DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003)

This 510(k) submission did not require clinical performance data because it demonstrated substantial equivalence to legally marketed predicate devices through robust non-clinical testing.

Summary

Regulation Number and Section

§ 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.