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The NCB Plating System is indicated for temporary internal fixation 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 tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

The provided text is a 510(k) summary for the Zimmer GmbH NCB® Plating System. This document describes a medical device, specifically a bone fixation system, and its premarket notification to the FDA.

Based on the content of the document, the device described is a mechanical implant, not an AI/software-based medical device. The "Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Performance and Conclusions: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This means the clearance for this device was based on mechanical testing and verification of design controls, not on a study proving performance against acceptance criteria for an AI or software algorithm. There is no mention of an algorithm, AI assistance, human readers, or ground truth establishment in the context of device performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/software device, as this document is about a physical orthopedic implant.

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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 proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

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

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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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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