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The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
• Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair, 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, Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
• Hip: Capsular Repair, acetabular labral repair.

The Arthrex Corkscrew FT is a fully threaded, vented suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from PLLA/BTCP and is offered sterile.

The provided text describes the Arthrex Corkscrew FT, a medical device for suture/soft tissue fixation to bone. The submission is a Special 510(k) to add a line extension to cleared BioComposite Suture Anchors. The performance data focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for acceptance criteria of a novel AI/software device. Therefore, much of the requested information regarding AI device evaluation (e.g., expert consensus, MRMC studies, training/test set sample sizes for AI, adjudication methods) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the study performed in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

Test Set Sample Size: Not specified for tensile testing. For bacterial endotoxin, sample size is typically dictated by the test method (e.g., a specific number of devices or extracts are tested).

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are performance tests conducted on the device itself.

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

Not applicable. This device is a physical medical implant, and its performance (tensile strength, pyrogenicity) is evaluated through objective lab testing, not human expert interpretation of data like in AI/imaging devices.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used for establishing ground truth in human-interpreted data, such as in clinical trials or AI performance evaluations, not for physical material testing.

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 submission is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" here is the objective measurement of physical properties:

• Tensile Strength/Pull-out Force: Measured directly through mechanical testing. The benchmark for equivalence is the performance of the legally marketed predicate device (K082810: Arthrex BioComposite Suture Anchors, and K061665: Arthrex Corkscrew FT).
• Pyrogenicity: Measured through standard bacterial endotoxin testing (EP 2.6.14/USP ) against established pyrogen limit specifications.

8. The sample size for the training set

Not applicable. Training sets are relevant for machine learning models, not for traditional physical device testing.

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

Not applicable. See point 8.

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The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Bicens Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is a 5.5 x 15mm fully threaded (FT) titanium screw that is available configured with suture.

This is a 510(k) summary for a medical device (surgical suture anchor) and does not contain information about software or AI performance, acceptance criteria, or a study meeting those criteria. Therefore, I cannot provide the requested details.

The provided text describes a traditional medical device (Arthrex Corkscrew FT III Suture Anchor with three #2 sutures) and its intended use, along with a statement of substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or any performance study beyond the declaration of substantial equivalence for the physical device.

Ask a specific question about this device