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The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

The purpose of this Special 510(k) is to add additional references to the LTJ Screws and Washer system. These new references are provided in titanium alloy compliant with ASTM F136 and have the same design and dimensions as the cleared LTJ Screws and Washer provided in stainless steel alloy compliant with ASTM F138. The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. The headless implants can be associated to an LTJ diameter 8 mm Washer. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.

I am sorry, but the provided text only contains regulatory information about AzurMeds Inc.'s LTJ Screws and Washer, including its classification, indications for use, and a comparison to predicate devices. It mentions that "Mechanical testing was performed under ASTM F543 requirements" and that "These tests showed the subject device to be substantially equivalent in terms of performance to the predicate LTJ Screws and Washer (K200987)."

However, the document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods. Therefore, I cannot generate the requested table and information about the device's performance against acceptance criteria.

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The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. They are provided in Stainless Steel Alloy compliant with ASTM F138. The headless implants can be associated to an LTJ diameter 8 mm Washer provided in Stainless Steel Alloy compliant with ASTM F138. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.

This document is a 510(k) summary for a medical device called "LTJ Screws and Washer." It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no acceptance criteria or study data related to device performance in terms of clinical outcomes or diagnostic accuracy involving human readers or AI systems. The performance data section refers exclusively to mechanical testing of the screws and not to any AI or human-assisted diagnostic performance.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device (a bone fixation fastener) and a different type of evaluation (mechanical properties rather than diagnostic accuracy).

Here's what can be extracted based on the primary focus of the request:

1. Table of Acceptance Criteria and Reported Device Performance:

2. - 7. (Information regarding AI/human reader studies, ground truth, sample sizes for test/training sets, adjudication, etc.):

This information is not applicable to the provided document. The document describes a metallic bone fixation fastener (LTJ Screws and Washer), which is a physical implant, not a diagnostic AI device or a device requiring human reader interpretation for its primary function. The "performance data" mentioned refers to mechanical testing of the physical screws to ensure they meet engineering standards for their intended use in bone fixation, not to the performance of any AI algorithm or human diagnostician.

8. Sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

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