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The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Repair/Tendon Reconstruction, Mid-foot Reconstruction, Bunionectomy
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
• Hip: Acetabular Labral Repair.

The Arthrex PushLock Anchors family is similar to the predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Arthrex PushLock Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify sample sizes for a 'test set' in the traditional sense of a clinical trial or AI model validation. The study described is focused on demonstrating substantial equivalence through mechanical and biomechanical testing. Therefore, the "test set" here refers to the samples of Arthrex PushLock Anchors and predicate devices used in the mechanical and biomechanical testing.

• Sample Size: Not explicitly stated for specific tests, but implies multiple samples were tested for each device type (proposed and predicate) to generate the "mechanical testing data."
• Data Provenance: Not explicitly stated, but as this is a 510(k) submission from a US manufacturer (Arthrex, Inc. in Naples, FL), it can be inferred that the testing was conducted either internally by the manufacturer or by a contracted laboratory, likely within the US. The nature of the testing (mechanical/biomechanical) would make it similar to a prospective study aimed at generating specific data points for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this submission. The "ground truth" for this type of device (suture anchor) in a 510(k) submission is established through:

• Engineering specifications and material science: For material equivalence.
• Mechanical and biomechanical testing standards: For performance equivalence (e.g., pull-out strength, insertion strength).
• Comparison to legally marketed predicate devices: For intended use and technological characteristics.

There's no mention of human experts interpreting data to establish a 'ground truth' in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or imaging-based AI assessments where multiple human readers interpret data that is inherently subjective or requires expert consensus. The assessment here is based on objective mechanical measurements and comparison to established predicate properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in tasks like image interpretation. The Arthrex PushLock Anchors are a physical medical device (suture anchors), not a diagnostic tool or an AI algorithm, so an MRMC study would be irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an algorithm. The "standalone" performance here would refer to the device's inherent mechanical properties, which are evaluated through the biomechanical and mechanical testing.

7. Type of Ground Truth Used

The ground truth used here is primarily:

• Predicate Device Data: The mechanical and material properties of the legally marketed predicate devices (Arthrex Bio-Composite Suture Tak Anchors, Arthrex BioComposite Suture Anchors, Arthrex PushLock, Tak and Corkscrew Suture Anchors) served as the benchmark or "ground truth" for comparison.
• Biomechanical and Mechanical Measurement Data: Objective, quantifiable results from laboratory testing regarding insertion and pull-out strength.
• Material Composition Standards: Specifications for the Bio, BioComposite, and Peek materials.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission pertains to a physical medical device. The "design iterations" and "testing" involved in its development might be analogous to a training phase, but there isn't a quantifiable "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the AI context. The development process would have involved engineering design principles, material science, and iterative testing where the "ground truth" for design decisions was based on desired mechanical performance, biocompatibility, and manufacturing feasibility, guided by existing knowledge of successful predicate devices.

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