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The Tritium Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6Al 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3Al/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load-sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Tritium® Sternal Cable Plate System) and primarily focuses on establishing substantial equivalence to a predicate device.

Here's why I cannot fulfill your request:

• No acceptance criteria or device performance data: The document states, "Engineering analysis was completed for the subject line extension product and demonstrated no new performance data was required for a determination of substantial equivalence." It also explicitly mentions, "No clinical performance data was required for a determination of substantial equivalence." This means there are no specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or reported device performance values available in this document.
• No details on clinical studies: Since no clinical performance data was required, there are no details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• No ground truth establishment for a study: As no studies are described with performance outcomes, there's no information on how ground truth would have been established for a test or training set.
• No training set information: The document discusses a device (implants, plates, cables, screws) used in surgical procedures, not an AI/ML algorithm that would require a training set.

The document mainly covers:

• The device's intended use and indications.
• Its components and materials.
• Its classification and product codes.
• Its substantial equivalence to a predicate device based on design, materials, and mechanical strength (without providing specific test results in this summary).

Therefore, I cannot extract the information requested as it is not present in the provided text.

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