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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 .

When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.

Device Description

The ZNN Tibial Nail System is a cannulated, intramedullary rod intended to restore the shape of the injured tibia to its pre-injured state. The nail implants are available in a variety of lengths and diameters to meet assorted anatomical needs and come in both Ti-6Al-4V alloy and 22-13-5 stainless steel to address surgeon preference. Minor modifications have been made to some of the instrumentation associated with the ZNN Tibial Nail System and to the surgical technique to allow implantation through an incision above the natural patella.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device can be implanted safely using the modified technique.	"All design verification activities confirmed that the ZNN Tibial Nails can be implanted using the modified suprapatellar surgical technique and instruments and that they provide a safe and repeatable approach similar to the surgical technique currently used for the predicate ZNN Tibial Nail System."
Effectiveness: Device effectively restores the shape of the injured tibia and provides temporary fracture fixation/stabilization using the modified technique.	"The final implanted location of the ZNN Tibial Nail implant is the same as with the currently cleared surgical techniques."
"The ZNN Tibial Nails can be implanted using the suprapatella technique and instruments and provide a safe and effective approach similar to the surgical technique currently used."
Risk Mitigation: Identified risks are properly mitigated.	"The design verification activities concluded that all risks identified were properly mitigated."
Substantial Equivalence: The modified system is substantially equivalent to the predicate device.	"Comparisons of the design, indications, and design control activities confirmed that the modified ZNN Tibial Nail System is substantially equivalent to the predicate ZNN Tibial Nail System."
Indications for Use: The modified system can be used for the same indications as the predicate (with one exception for the suprapatella approach).	"The indications for use of the modified system and the original system remain the same." (Referencing the listed indications in the document). The exception: "When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures."
Fundamental Scientific Technology: The modification does not change the fundamental scientific technology.	"The addition of an optional suprapatella technique and the associated instrumentation does not change the fundamental scientific technology of the ZNN Tibial Nail System."

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."

Therefore, there was no "test set" in the traditional sense of a clinical study involving patients. The performance data relied on "design verification activities." The document does not provide details on the sample size or provenance of data used for these design verification activities (e.g., number of tests, materials tested, etc.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission is for a modification to an existing device, and clinical data was deemed unnecessary.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a physical medical device (intramedullary fixation rod), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on engineering design verification and validation activities rather than clinical outcomes or expert consensus on patient data. This includes evaluations of the instruments and the surgical technique to ensure they perform as intended and safely.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI algorithm. The performance of the modified device was established through non-clinical design verification activities to demonstrate substantial equivalence to the predicate device.

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