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The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

The XTREME-LOOP device is a soft tissue fastener used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) reconstruction. The device was deemed substantially equivalent to the predicate device, SECURE-LOOP (K151601), based on performance testing. The reported information focuses on the device's physical properties and biological safety rather than clinical performance metrics in the context of diagnostic accuracy or clinical outcomes often seen in AI/ML device submissions.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided document does not specify a "test set" in the context of patient data or image datasets, as this device is a physical implant. The testing described is pre-clinical engineering and biological safety testing. Therefore, information on sample size and data provenance like country of origin or retrospective/prospective nature is not applicable in the way it would be for AI/ML device studies. The sample sizes would pertain to the number of devices or test samples evaluated in the mechanical and biological tests. These specific numbers are not detailed in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. Ground truth, in the context of expert consensus, refers to a human interpretation of data (e.g., medical images). For a physical medical device like the XTREME-LOOP, the "ground truth" for performance is established through standardized laboratory testing and material characterization, not expert human interpretation.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3.

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:

This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML diagnostic or therapeutic aid that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The XTREME-LOOP is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's performance was established through:

• Mechanical Testing: Standardized engineering tests (strength, stiffness, fatigue, functional testing) comparing the XTREME-LOOP to the predicate device, SECURE-LOOP.
• Biological Safety Testing: Adherence to established standards for pyrogenicity, specifically:
  • Turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with ANSI/AAMI ST72:2011 for endotoxins.
  • Rabbit pyrogenicity test per USP, General Chapter .

8. The sample size for the training set:

This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as point 8.

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