(77 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out force equivalent to the predicate after 26 weeks degradation. | Tensile testing demonstrated that the pull-out force of the device is equivalent to the predicate. |
| Meets pyrogen limit specifications. | Bacterial endotoxin testing per EP 2.6.14/USP demonstrated that the device meets pyrogen limit specifications. |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.