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The Comprehensive® Proximal Humeral Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus.

The Comprehensive® Proximal Humeral Plating System is comprised of anatomic plates in seven lengths and non-locking, locking and variable angle 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.)

The provided information indicates that the device is a Comprehensive® Proximal Humeral Plating System, a bone fixation device. The study performed is non-clinical, and primarily relies on engineering analysis to demonstrate substantial equivalence to predicate devices, rather than a clinical trial involving patient data or human reader evaluation. Therefore, many of the typical questions regarding clinical studies, human readers, and ground truth establishment are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for this type of non-clinical engineering analysis. The "test set" would consist of the physical devices undergoing mechanical testing or computational models for engineering analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for mechanical properties in this context would be established through engineering principles, mechanical testing, and comparison to established predicate devices, rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data, which was not performed here.

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 study was done, as this is a bone fixation system and not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for determining equivalence for "Plate Strength" was an engineering analysis and comparison to the performance of predicate devices (K062494, K082625). This likely involved mechanical testing of the physical properties and structural integrity of the plates and screws.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of this device and study type. The "IntelliFIT Technology" mentioned for plate sizing used "contour analysis to map patterns in complex bone on cadaveric specimens", which could be considered a form of data used in the design process, but not a "training set" for an AI algorithm in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there was no training set. The "IntelliFIT Technology" used "contour analysis to map patterns in complex bone on cadaveric specimens" to determine pre-defined plate sizes. The "ground truth" for this design process would be anatomical data derived from cadaveric specimens.

Additional Information from the Document:

• Study Type: Non-clinical tests (Engineering Analysis)
• Clinical Studies: None were conducted.
• MR Environment: Studies performed on 316L Stainless Steel Plating Systems per ASTM F138 determined them to be MR Conditional according to ASTM F2503-08.
• Conclusion: "No mechanical or clinical testing was necessary for a determination of substantial equivalence. The results of engineering analysis indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices."

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