(96 days)
The MedShape Solutions, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures:
- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
The proposed WedgeLoc™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).
Each suture anchor is preloaded with two non-absorbable USP No. 2 sutures. The polyblend surgical suture provided with the proposed WedgeLoc™ Suture Anchor is provided by CP Medical, and has previously been cleared for market under K041894. In addition, these sutures meet USP requirements as described in the USP monograph for non-absorbable surgical sutures. Opti-Fiber™ non-absorbable polyblend surgical sutures are made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover and are identical to the CP-Fiber™ USP No. 2 sutures described in K041894.
This is a 510(k) summary for a medical device called the WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures. This document aims to demonstrate substantial equivalence to predicate devices, rather than establishing primary safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance reporting as one might expect for a novel device.
The "study" referenced in this document is an in-vitro functional performance testing to show the new device performs at least as well as the predicate.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria in a quantitative table for "device performance." Instead, it relies on demonstrating that the proposed device performs "as well as or better than" the predicate device in functional performance testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional performance in-vitro as well as or better than predicate device (qualitative) | "Analysis of the results substantiates the statement that the proposed device performs as well as or better than the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "functional performance testing," but the number of samples or tests conducted is not provided.
- Data Provenance: In-vitro (laboratory testing, not human or animal data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this type of test is typically based on engineering specifications and direct measurement of mechanical properties, rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. This was an in-vitro functional test, not a study requiring adjudication of expert opinions or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a medical device (suture anchor), not an AI or imaging device that would typically involve MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI or algorithm-based device.
7. The Type of Ground Truth Used
The ground truth for the in-vitro functional performance testing would be the measured mechanical properties of the suture anchor and its fixation strength in bone analogues, compared against the known performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
§ 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.