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The NCB Plating System is an extramedullary internal fixation plate system to be used for proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

AI/ML Overview

Here's an analysis of the provided document regarding the acceptance criteria and study for the Zimmer NCB® Plating System:

This document is a 510(k) premarket notification for a medical device (a bone plate system), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel drug or a high-risk AI-powered diagnostic device.

Therefore, many of the requested data points (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not provided in this type of submission. The safety and effectiveness are established primarily through non-clinical performance testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Predicate Comparison & Non-Clinical Testing)	Reported Device Performance
Mechanical Performance: Equivalent or superior to predicate devices for intended use (temporary internal fixation and stabilization of fractures and osteotomies of long bones). This would typically involve criteria for strength, fatigue life, and torsional rigidity appropriate for bone fixation.	"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."
"The NCB Plating System Proximal Tibia plates have the same intended use, similar performance characteristics, are made of the same material and are similar in design to the predicate devices."
Material Properties: Made of the same material as predicate devices.	"Made of the same material" as predicate devices.
Biocompatibility: (Implied, as it's a bone implant)	Not explicitly detailed, but implied by regulatory compliance and use of approved materials.
Design: Similar in design to predicate devices.	"Similar in design to the predicate devices."
Intended Use: Consistent with predicate devices.	"The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones," which is "the same intended use" as the predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for clinical data.
The document refers to "non-clinical (laboratory) performance testing." For such testing, sample sizes would refer to the number of test articles (e.g., bone plates) evaluated. This information is typically detailed in the test reports themselves, which are referenced in the submission but not included in this summary. The data provenance is from laboratory testing (likely internal or contract labs) supporting the submitter (Zimmer, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.
This device relies on non-clinical performance data and substantial equivalence to predicate devices, not on expert-adjudicated clinical test sets for ground truth.

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

Not applicable.
No clinical test set requiring expert adjudication is described.

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 is a mechanical bone plating system, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI are irrelevant.

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

Not applicable.
This is a mechanical device, not an algorithm.

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

For the "non-clinical (laboratory) performance testing," the "ground truth" would be established by physical measurements, mechanical engineering standards, and performance specifications derived from regulatory requirements and comparisons to predicate device performance. For instance, the "truth" for a fatigue test is whether the device withstands a specified number of cycles without failure.

8. The sample size for the training set

Not applicable.
There is no "training set" in the context of this mechanical device submission.

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

Not applicable.
There is no "training set" or corresponding ground truth establishment described for this mechanical device.

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