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The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality.

MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy.

MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws.

The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.

The provided text describes a 510(k) premarket notification for the DePuy Synthes MatrixSTERNUM Fixation System, which is a metallic bone fixation appliance.

It is crucial to understand that this document describes a submission for a medical device (hardware), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information regarding acceptance criteria and studies that prove the device meets acceptance criteria are focused on the mechanical, material, and biological performance of physical implants, not on the performance of an AI algorithm in tasks like image interpretation or diagnosis.

Because the request is specifically about AI/SaMD performance criteria (e.g., sample size for test set, expert ground truth establishment, MRMC studies, standalone performance, training set data), the provided text does not contain the information needed to answer these questions for an AI/SaMD product.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This directly indicates that no clinical performance study, multi-reader multi-case (MRMC) study, or standalone algorithm performance study (as would be typical for AI/SaMD) was conducted.
• The performance data provided is under "Non-clinical Performance Data" and includes:
  • Mechanical performance evaluation and testing: Comparing the subject plates to predicate devices.
  • Magnetic resonance compatibility assessment.
  • Endotoxin testing.
  • Biocompatibility evaluation and testing (in accordance with ISO 10993-1).

These are standard non-clinical tests for orthopedic implants to demonstrate safety and effectiveness and substantial equivalence to existing devices. They are not metrics or study designs relevant to AI/SaMD performance.

Therefore, I cannot populate the requested table and answer the subsequent questions in the context of an AI/SaMD product, as the provided text pertains to a physical medical device.

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