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The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.

The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices consist of an ultra-high molecular weight polyethylene graft suspension loop and a titanium cortical button. The devices facilitate knee ligament repair/reconstruction through placement and retention of soft tissue or bone-tendon within bone.

The ULTRABUTTON QUAD Adjustable Fixation Device and the ULTRABUTTON BB Adjustable Fixation Device is available in one size. The UTLRABUTTON TIB Adjustable Fixation Device is available in a small, medium, or large size.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, it is an FDA 510(k) clearance letter and summary for a physical medical device: the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample size used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The available text describes the device, its intended use, indications for use, and a summary of performance data for non-clinical testing to demonstrate substantial equivalence to a predicate device. This performance data relates to mechanical and material characteristics of the physical device, not an AI algorithm.

Specifically, the "Summary of Performance Data" section states:

• "Device cyclic displacement, device repair strength, and construct stiffness met the acceptance criteria established by the predicate device (K153186)."
• "Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results."
• "Bacterial endotoxin testing was completed and met acceptable limits per ANSI/AAMI ST72:2019."
• "The devices have a three (3) year shelf-life. Storage and stability is based on completed packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results."
• "Sterile adoption was completed per ISO 11135:2014+A1:2018."

These are typical performance tests for surgical fixation devices to ensure mechanical integrity, biocompatibility, sterility, and shelf-life, not for assessing the diagnostic or predictive performance of an AI algorithm.

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