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The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 20mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use.

The provided text is related to a 510(k) submission for a medical device called the "Latarjet Cortical Screw Set." This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices.

The information you are requesting about "acceptance criteria and the study that proves the device meets the acceptance criteria" (specifically for AI/algorithm performance) is not applicable to this submission.

Here's why, based on the provided text:

• Device Type: The Latarjet Cortical Screw Set is a physical implantable device (bone fixation screw) used in orthopedic surgery. It is not an AI/algorithm-based diagnostic or treatment device.
• Regulatory Pathway: The submission is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance (e.g., mechanical testing, biocompatibility) to show it's as safe and effective as existing devices. It does not involve clinical studies to demonstrate the performance of an AI algorithm against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• Lack of AI/Algorithm Information: There is no mention of any AI component, software, diagnostic algorithm, or any form of "AI assistance" in the entire document. The device is purely mechanical.

Therefore, I cannot extract the information requested as it pertains to AI/algorithm performance studies, as such studies were not conducted or described for this specific device.

The study referenced in the document is a "validation" to verify that the device's "performance is the same" as the predicate device based on its technological characteristics. This would typically involve engineering tests (e.g., mechanical strength, fatigue, torque, biocompatibility) rather than clinical performance metrics in humans or AI performance metrics.

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The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall lengths: 36mm - 42mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied non-sterile, for single patient use.

This 510(k) summary for the Latarjet Cortical Screw Set indicates that it is a bone fixation screw and therefore does not involve an AI/ML powered device. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance verified by validation (likely mechanical or material testing, not clinical studies in the context of AI/ML).

Therefore, the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (such as MRMC studies, standalone performance, training sets) is not applicable to this device.

The document primarily addresses the substantial equivalence of a physical medical device (bone screw) to existing devices, relying on comparisons of design, materials, and intended function rather than algorithmic performance evaluation.

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