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TriMed Bridge Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.

TriMed Bridge plates are temporary joint spanning plates are indicated to be used as an aid to the treatment of fractures, osteotomies and non-unions of the radius. TriMed Bridge plates are manufactured from medical grade stainless steel. There plates are compatible with 2.7mm and 3.2mm locking and non-locking screws. Devices included in this application will be distributed as part of the TriMed Wrist Fivation Sustom 3 cleared under K222637.

This document describes the premarket notification for the TriMed Bridge Plates (K241942). The information provided focuses on the substantial equivalence of the device to a legally marketed predicate and does not detail specific acceptance criteria or a study proving those criteria are met for the device performance in a way that would typically apply to software or AI/ML devices.

Instead, the provided text describes the non-clinical testing conducted to demonstrate the safety and effectiveness of the physical medical device.

Therefore, many of the requested sections (2-9), which are highly relevant to AI/ML device studies, are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to mechanical testing based on FDA guidance and ASTM standards, rather than clinical performance metrics. The "acceptance criteria" here are compliance with these mechanical test standards.

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

Not applicable. The study involved mechanical testing of physical device prototypes, not a test set of data.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on images) is not relevant to mechanical device testing. The "ground truth" for mechanical testing is established by the specifications and performance metrics outlined in the ASTM standard.

4. Adjudication method for the test set

Not applicable. No expert adjudication process similar to clinical or image review was 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 physical medical device (bone fixation plate), not an AI/ML software. No MRMC study was performed.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

For the mechanical testing, the "ground truth" is compliance with the established ASTM F382-17 standard for static and dynamic four-point bending. This is a standardized performance benchmark for the physical properties of the material and design.

8. The sample size for the training set

Not applicable. No training set as understood for AI/ML was used. The focus is on the physical properties of the device.

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

Not applicable.

Summary regarding the "study that proves the device meets the acceptance criteria":

The provided text indicates that the "study" was a series of non-clinical mechanical tests performed on the TriMed Bridge Plates. These tests were conducted according to the recommendations in the FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway," and specifically followed the ASTM F382-17 standard for static and dynamic four-point bending.

The purpose of these tests was to demonstrate the device's substantial equivalence to the predicate device in terms of its mechanical properties, thereby inferring its safety and effectiveness for its intended use. The statement "Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. [believes] that the proposed devices (Bridge plates, 2.7mm locking screws) are substantially equivalent to the currently marketed predicate device" confirms that these non-clinical tests served as the basis for the equivalence determination.

Clinical studies were explicitly stated as NOT having been conducted for the subject devices. This is typical for Class II devices seeking 510(k) clearance where substantial equivalence can often be demonstrated through non-clinical testing and comparison to predicates.

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