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The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

The Medline Cannulated Screws are manufactured from titanium alloy or stainless steel. The screws are offered in various diameters, lengths, and thread lengths. Both headed and headless screw options are available as well as optional washers for the headed screws.

The provided text describes a 510(k) premarket notification for the Medline Cannulated Screw. This type of filing is for medical devices that are substantially equivalent to a predicate device and typically does not include extensive clinical studies or acceptance criteria tables related to AI/software performance. Instead, it focuses on demonstrating safety and effectiveness through mechanical testing and comparison to an already approved device.

Therefore, many of the requested categories (2-9) are not applicable to this document as they pertain to studies involving AI/software for diagnostic or image analysis, which is not the nature of this device.

Here's the information extracted and an explanation for the non-applicable sections:

Acceptance Criteria and Device Performance

This document does not present specific acceptance criteria in the way one might for a software or AI-driven device, nor does it report performance metrics like sensitivity or specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device through material composition, design, and functional performance testing.

The document states:
"Functional performance testing of the Medline Cannulated Screws demonstrated device effectiveness in accordance with relevant ASTM F382 and F543 test methods."

These ASTM standards cover mechanical testing of metallic bone screws, such as bending fatigue, torsional strength, and static axial pull-out. The "acceptance criteria" are implied to be that the Medline Cannulated Screws meet or exceed the performance thresholds defined by these ASTM standards, which would be comparable to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Non-Applicable Sections for this Device (Medline Cannulated Screws - a physical implant)

The following sections are designed for AI/software-driven medical devices and are not relevant to the 510(k) submission for a physical orthopedic implant like the Medline Cannulated Screw:

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of data in the context of AI/software for this physical device. Performance is assessed through mechanical testing of physical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI, involves expert interpretation of data. For a bone screw, performance is measured mechanically and objectively.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for the mechanical performance of a screw.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This relates to AI assistance for human readers, which is not relevant for a physical implant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a bone screw's performance is its mechanical properties as measured by standardized tests.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable. No training set exists.

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