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The TriMed Bearing Plate is intended for use as an aid the fracture healing. The implants are applied to a to fracture hound secured with bone screws and threaded or unthreaded locking fixation pegs.

The TriMed Bearing Plate is indicated for:

1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion

The TriMed Bearing Plate is a bone fixation plates are inc frined bound to fracture fixation. The plates are is ased as an an an either medical grade 316 stainless manalabourea (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136). freamfamilian which workeristics of the devices are provided in enclosures 8 and 9.

The provided text is a 510(k) summary for the TriMed Bearing Plate. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a study in the same way clinical trials for new drugs or software algorithms are conducted.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not present in this document.

This document specifically states: "report an intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

Here's why the requested information is absent and what can be inferred from the document:

• Acceptance Criteria & Reported Device Performance: This device, being a bone fixation plate, is evaluated based on its material properties (e.g., medical grade stainless steel or Titanium alloy) and its functional equivalence to existing plates. The document states, "The TriMed Bearing Plate has identical technical characteristics to existing bone plates in common use." There are no explicit performance metrics like sensitivity, specificity, or accuracy mentioned as there would be for a diagnostic or AI device.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): A 510(k) for a physical medical device like this typically relies on bench testing for material and mechanical properties, and comparison to predicate devices, rather than clinical studies with human participants that would involve test sets, ground truth, or experts in the way your prompt describes for AI/diagnostic devices. The regulatory process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed device.
• Ground Truth: For a bone fixation plate, "ground truth" would be related to mechanical integrity and biocompatibility, typically established through material testing standards and established clinical use of similar materials and designs. It's not about an "expert consensus" on an image or pathology.
• Training Set (for AI/Algorithms): The concept of a "training set" is irrelevant for this type of physical medical device, as it does not involve any algorithms or machine learning.

What the document does provide:

• Predicate Devices: The document lists several predicate devices (e.g., Zimmer Forte plate, Synthes bone fixation plates, Smith-Nephews bone fixation plates and screws). The "substantial equivalence" is established by comparing the TriMed Bearing Plate to these existing devices.
• Material Specifications: The device is made of "medical grade 316 stainless steel (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136)." These are standard materials used in similar devices, implying they meet established performance and safety requirements.
• Intended Use/Indications for Use: Fixation of fractures or non-unions of the distal radius, and osteotomies of the distal radius to correct malunion. These are typical indications for bone fixation plates.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI-powered diagnostic tool. Therefore, the specific criteria and study details requested are not applicable or found within this document.

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