(29 days)
The Arthrex FiberTak Suture Anchor is 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, 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, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, and Medial Patellofemoral Ligament Repair/Reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair
The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use
This document is a 510(k) Premarket Notification for the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K203268) to expand its indications for use to include Medial Patellofemoral Ligament Repair/Reconstruction.
Therefore, the "study" described is mechanical testing rather than a typical clinical study involving human readers or AI algorithms as would be the case for medical imaging devices.
Here's the information based on the provided document:
Acceptance Criteria and Device Performance for Arthrex FiberTak Suture Anchor
Type of Device: Suture Anchor (Class II Medical Device)
Purpose of Submission: Expansion of Indications for Use to include Medial Patellofemoral Ligament Repair/Reconstruction.
This submission relies on mechanical performance testing to demonstrate substantial equivalence for the expanded indication, rather than a clinical study involving human readers or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Pull-out (Tensile) Strength for Medial Patellofemoral Ligament Repair/Reconstruction | "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex FiberTak Suture Anchor met the criteria established by published literature for Medial Patellofemoral Ligament Repair/Reconstruction." (Specific numerical values for acceptance criteria or performance are not provided in this summary, but the statement confirms that the device met the pre-defined standards derived from literature for this specific application.) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in this summary. The "test set" here refers to the samples used in the mechanical testing. The standard practice for such testing involves a sufficient number of devices/constructs to achieve statistical significance.
- Data Provenance: The study is reported as "Mechanical testing", implying it was conducted as laboratory-based testing. Country of origin and retrospective/prospective nature are not applicable in the typical sense for this type of testing (it's not patient data).
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This submission pertains to a physical medical device (suture anchor) and its mechanical properties, not a diagnostic or AI-driven imaging device that would require expert-established ground truth from clinical data. The "acceptance criteria" here are based on established engineering and biomechanical literature for sufficient tensile strength in the context of ligament repair.
4. Adjudication Method for the Test Set
- N/A: As this is mechanical testing, there is no adjudication process involving multiple human reviewers. The results are quantitative measurements of physical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study was not performed as this is not an imaging or diagnostic device. The study is focused on the mechanical performance of the suture anchor.
6. Standalone Performance (Algorithm Only)
- N/A: This is not an algorithm or AI device.
7. Type of Ground Truth Used
- Literature-established Mechanical/Biomechanical Criteria: The "ground truth" for success in this context is the fulfillment of established criteria for pull-out (tensile) strength, derived from published literature relevant to Medial Patellofemoral Ligament Repair/Reconstruction.
8. Sample Size for Training Set
- N/A: No "training set" is applicable as this is not a machine learning model.
9. How Ground Truth for Training Set was Established
- N/A: No "training set" is applicable.
§ 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.