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The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in coniunction with staples.

The Daytona® Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single-use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

This appears to be a 510(k) summary for a medical device (Daytona® Small Stature Growth Rod Conversion Set). Based on the provided text, the submission does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria based on performance data.

Instead, the submission relies on a demonstration of substantial equivalence to an already legally marketed predicate device (Xia® Growth Rod Conversion Set, K142114) through non-clinical mechanical testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is explicitly stated as "Not applicable" for clinical testing in the provided document.

Here's a breakdown of why based on the text:

• "Non-Clinical Testing: The Daytona® Small Stature Growth Rod Conversion Set demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798." This indicates that the device's performance was compared to the predicate through mechanical tests, not clinical efficacy or diagnostic accuracy.
• "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This explicitly states that clinical performance data (which would typically involve patient outcomes, diagnostic accuracy, or human-in-the-loop studies related to AI/algorithm performance) was not used for this submission.

The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly relevant for AI/Machine Learning device submissions where performance is assessed against clinical ground truth. This document pertains to a mechanical implant device where substantial equivalence is demonstrated through engineering and mechanical testing standards.

Therefore, many of your specific points for requested information (1-9) are not applicable to the content provided.

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