(183 days)
The Arthrex Corkscrew suture anchors are intended to be used 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 Repair, Bankart 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 and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, 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 or 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, gluteus medius repair.
The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart 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 and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial 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: Capsular repair, acetabular labral repair, gluteus medius repair.
The Arthrex Corkscrew and SwiveLock Suture Anchors consist of cannulated anchors manufactured from polyetheretherketone (PEEK) or Titanium with an integral or separate eyelet. They are pre-loaded on a handled inserter. Suture, with or without needles, and a suture threader may also be provided.
This document is a 510(k) premarket notification for Arthrex Corkscrew and SwiveLock Suture Anchors. It outlines the summary of safety and effectiveness, but it does not describe an acceptance criteria table or a study that proves the device meets specific performance criteria in the way requested for AI/software devices.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on design features, intended use, and mechanical testing.
Therefore, I cannot directly extract the exact information requested in the prompt's numbered list regarding acceptance criteria and a study proving their fulfillment as this is not a clinical study report for an AI/software device.
However, I can provide information based on the type of evidence presented in this 510(k) summary:
-
Acceptance Criteria & Device Performance: This document does not present specific acceptance criteria in a tabular format with corresponding device performance metrics for a clinical or AI-based assessment. Instead, it relies on demonstrating that the new devices perform comparably to the predicate devices through mechanical testing. The implication is that if the new device performs similarly in these mechanical tests to an already cleared device, it "meets acceptance criteria" for substantial equivalence.
Acceptance Criteria (Implied by equivalence) Reported Device Performance (Implied by equivalence) Biocompatibility Deemed acceptable (not explicitly stated here, but typically required for medical devices) Mechanical strength (e.g., pull-out strength) Demonstrated to be substantially equivalent to predicate devices through insertion testing, static pull-out testing, fatigue testing, and suture abrasion testing data. Specific numerical results are not provided in this summary. Device functionality Deemed substantially equivalent to predicate devices. -
Sample size used for the test set and the data provenance: Not applicable in the context of clinical/AI test sets. The "test set" here refers to the physical devices undergoing mechanical testing. The provenance of these devices would be from the manufacturer (Arthrex), and the testing would be conducted in a lab environment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical sense, is not established for this type of submission. The "truth" is based on the physical properties and performance of the devices as measured in mechanical tests.
-
Adjudication method for the test set: Not applicable.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This is a submission for a physical medical device (suture anchors), not an AI/software product that assists human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
-
The type of ground truth used: For this physical device, the "ground truth" is established through mechanical testing data (insertion testing, static pull-out testing, fatigue testing, and suture abrasion testing). These tests provide objective measurements of the device's physical and mechanical properties.
-
The sample size for the training set: Not applicable. This document pertains to physical medical devices, not AI/machine learning algorithms that require training sets.
-
How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission successfully demonstrates substantial equivalence by comparing the new Arthrex Corkscrew and SwiveLock Suture Anchors to previously cleared predicate devices through direct comparison of design features, intended uses, and results from mechanical performance tests. It does not involve AI, clinical efficacy studies with human readers, or a ground truth established by expert consensus on clinical cases.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.