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The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

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

This document is a 510(k) premarket notification from Zimmer, Inc. to the FDA for the NCB® Plating System. The notification focuses on establishing substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on performance data.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The "Performance Data" section explicitly states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This indicates that the evaluation was based on laboratory testing, not a clinical study involving human patients or complex AI models that would require the detailed information you've requested.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Reported Device Performance Table: The document does not define specific performance metrics or acceptance criteria that a device must meet (e.g., accuracy percentages, sensitivity, specificity for an AI model). It also doesn't report performance against such criteria.
• No Information on Test Set or Data Provenance: This being a medical device (plate and screws), there is no "test set" in the context of an AI study. The "Performance Data" refers to non-clinical (laboratory) testing, not data provenance or sample sizes for testing an algorithm.
• No Experts for Ground Truth, Adjudication, or MRMC Study: These concepts are relevant to studies involving human reading or AI interpretation of medical images/data. The NCB® Plating System is a physical implant, so these considerations do not apply.
• No Standalone Algorithm or Ground Truth Type: Again, this is a physical medical device, not an algorithm.
• No Training Set or Ground Truth for Training Set: These are concepts related to machine learning and AI development, which are not applicable to the Zimmer NCB® Plating System as described.

In summary, the provided document is a regulatory submission for a physical medical device (bone plating system) seeking substantial equivalence, not a performance study of a device that relies on complex data analysis or AI.

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