(117 days)
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
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 Stainless Steel Tibial Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the tibia. The Zimmer Natural Nail System Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. All nails are available in a variety of lengths and diameters to meet 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 are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. All components are made from stainless steel.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer® Natural Nail™ System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective." |
| Effectiveness | "The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective." |
| Material | "The Zimmer Natural Nail system is similar or identical in ... materials ... to the predicate device(s)." |
| Sterility | "The Zimmer Natural Nail system is similar or identical in ... sterility ... to the predicate device(s)." |
| Performance Characteristics | "The Zimmer Natural Nail system is similar or identical in ... performance characteristics to the predicate device(s)." |
| Intended Use | "The Zimmer Natural Nail system is similar or identical in intended use ... to the predicate device(s)." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical data and conclusions were not needed for this device."
This indicates that:
- No test set using human data was employed.
- No data provenance (country of origin, retrospective/prospective) is applicable for a clinical test set.
- The evaluation was based on non-clinical (lab) performance testing and comparison to predicate devices, not on a test set involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As clinical data was not used, there was no need for experts to establish ground truth for a clinical test set.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document indicates that clinical data and conclusions were not needed, and the evaluation was based on non-clinical testing and substantial equivalence to predicate devices. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is an intramedullary nail system, a physical surgical implant, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth for the device's performance was established through:
- Non-clinical (lab) performance testing: This would involve engineering and biomechanical tests to assess mechanical properties, durability, and other physical characteristics. The "ground truth" here is derived from measurable physical properties and engineering standards.
- Comparison to predicate devices: The device's "ground truth" for safety and effectiveness is largely based on its similarity to previously cleared devices which have an established record of safety and effectiveness.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
§ 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.