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The ExploR® Radial Head Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal radius.

The Explor® Radial Head Plating System is comprised of 3 styles of plates (neck plates, rim plates and rim long plates) in two sizes (small and standard) each and locking and non-locking screws in multiple lengths. Plate sizing and contouring was developed through the use of Biomet's IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)

Here's a summary of the device's acceptance criteria and the study details based on the provided text:

Device Name: ExploR® Radial Head Plating System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "No mechanical or clinical testing was necessary for a determination of substantial equivalence." This implies that the primary acceptance criterion was demonstrating equivalence to predicate devices, particularly in mechanical performance.

Study Details:

The provided documents describe a premarket notification (510(k)) submission for the ExploR® Radial Head Plating System. The study conducted was primarily a non-clinical engineering analysis to demonstrate substantial equivalence to legally marketed predicate devices.

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

• Test Set Sample Size: Not applicable. No "test set" in the sense of a dataset of patient cases was used. The evaluation centered on engineering analysis and comparison to predicate devices.
• Data Provenance: The engineering analysis was performed internally by Biomet Manufacturing Corp. As it's an engineering analysis, country of origin is not relevant in the sense of clinical data. It's retrospective in the sense that it relies on established engineering principles and comparisons to existing devices.

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

• Not applicable. There was no "test set" requiring ground truth established by experts in a clinical context. The "ground truth" for the engineering analysis would be the established performance characteristics of the predicate devices and accepted engineering principles, likely assessed by internal engineers and regulatory specialists.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process 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:

• No MRMC comparative effectiveness study was done. This device is a medical implant (bone fixation system), not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Engineering Analysis: The "ground truth" for the performance evaluation was established through engineering analysis and comparison to the mechanical properties and established performance of existing legally marketed predicate devices. This is a comparative performance information summary rather than a clinical ground truth.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not a machine learning algorithm requiring a "training set." The design process for the plates involved "Biomet's IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing." However, this is for design, not for training an algorithm for a separate performance validation. The document states that the software is "not used to create individual, patient matched plates."

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

• Not applicable, as there was no training set in the context of an algorithm. However, for the design process involving IntelliFIT Technology, the "ground truth" would have been the anatomical patterns and complex bone contours observed in "cadaveric specimens." The establishment of this ground truth would involve anatomical dissection and imaging of these specimens.

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