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510(k) Data Aggregation
(18 days)
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
The information provided in the document focuses on regulatory clearance for a medical device (Zimmer Periarticular Locking Plate System) and does not describe acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance. The document explicitly states that "Clinical data and conclusions were not needed for this device."
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are mentioned in terms of a study outcome. The document only states that "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This is a general statement, not a detailed report of performance against specific criteria.
- Sample sized used for the test set and the data provenance: No test set is described. The document refers to "non-clinical (laboratory) performance testing" but provides no details on samples, sizes, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth establishment for a test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or expert adjudication is described.
- 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 document is for a medical implant (bone plate system), not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone fixation plate, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no ground truth for diagnostic or interpretative purposes is mentioned. The "ground truth" for a bone plate would typically be its mechanical integrity or biological response, which is assessed via laboratory and clinical (if required) testing, not expert consensus on images.
- The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm-based device.
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