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The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in various surgeries such as foot. ankle, elbow, hand, and wrist. Specifically;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Foot: Hallux Valgus reconstruction
Ankle: Mid-foot reconstruction

The Arthrex Mini Bio-Anchor is manufactured using poly(L-lactide, co-D-L-lactide) or PLDLA. It is a threaded anchor with a suture evelet for inclusion of the Arthrex Fiberwire™or other appropriate suture. The Mini Bio-Anchor is available with a reusable guide for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone by using a uniquely sized single-use sterile drill.

This document is a 510(k) summary for the Arthrex Mini Bio-Anchor, a medical device. It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving acceptance criteria. Therefore, the information requested in the prompt, which pertains to studies demonstrating performance against acceptance criteria, training and test sets, expert involvement, and statistical analyses, is not present in this type of document.

The document provides:

• Device Description: The Arthrex Mini Bio-Anchor is a threaded, bioabsorbable (PLDLA) anchor for suture fixation to bone, available with a reusable guide and requiring a single-use drill for preparation.
• Intended Use/Indications for Use: Fixation of suture to bone in various surgeries (foot, ankle, elbow, hand, wrist), with specific examples like Biceps Tendon Reattachment in the elbow and Hallux Valgus reconstruction in the foot.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to predicate devices based on having the same intended use and not raising new safety or effectiveness questions due to its material, which is well-characterized in predicate devices.

Missing Information:

The document does not contain any of the following, which would typically be found in a study report designed to prove a device meets acceptance criteria:

1. A table of acceptance criteria and reported device performance: This document does not define specific performance metrics or acceptance criteria for the device (e.g., tensile strength, pull-out force, biodegradation rate targets) nor does it report any test results against such criteria.
2. Sample size used for the test set and data provenance: No test sets or data are mentioned.
3. Number of experts used to establish ground truth and their qualifications: No experts are mentioned as establishing ground truth for performance testing.
4. Adjudication method for the test set: Not applicable as no test sets or adjudicated results are involved.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical implant, not an algorithm or AI.
7. Type of ground truth used: No performance testing results are presented, so no ground truth data is discussed.
8. Sample size for the training set: Not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

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