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The Opus TwinLock bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The Opus® TwinLock™ device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The provided text is a 510(k) summary for the Opus TwinLock Knotless Fixation Device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

The 510(k) process for medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria in the same way a drug or a novel, high-risk device might.

Therefore, I cannot populate the requested table and answer the questions based on the provided text.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance (Table and Q1): The document does not define any specific performance metrics (e.g., tensile strength, pull-out force, dissolution rates, clinical success rates, accuracy, sensitivity, specificity, etc.) that the device must meet, nor does it report any experimental results against such criteria. The "study" mentioned here is the comparison to the predicate device, not a performance study against acceptance criteria.
• Sample Size, Data Provenance, Experts, Adjudication (Q2-4): These questions are relevant for studies involving human data or expert review (e.g., diagnostic device performance, clinical outcomes). Since this is a submission for a bone anchor device demonstrating substantial equivalence via material and design comparison, these elements are not present. There is no "test set" in the context of diagnostic performance here.
• MRMC Comparative Effectiveness (Q5): This is specific to diagnostic imaging devices where human readers interpret images with and without AI assistance. It's not applicable to a knotless fixation device.
• Standalone Performance (Q6): "Standalone" performance usually refers to an algorithm's performance without human intervention. This device is a physical implant, not an algorithm.
• Type of Ground Truth (Q7): "Ground truth" is typically used in the context of diagnostic accuracy studies (e.g., pathology confirmation for a cancer detection algorithm). For an orthopedic implant, the "ground truth" would be related to its mechanical properties and biocompatibility, which are usually assessed through engineering tests and material characterization, not expert consensus or pathology on a "test set" in the same vein.
• Training Set Sample Size & Ground Truth (Q8-9): These are concepts related to machine learning models. This document is about a medical device, not an AI/ML product.

In summary, the provided 510(k) document is not a study report demonstrating compliance with specific acceptance criteria in the manner requested by your questions. It's a regulatory submission affirming equivalence to an existing device.

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