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The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

• Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Foot/Ankle: Valgus 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
• Ulnar Collateral Ligament Scapholunate Ligament Reconstruction, Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
• Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating.

The provided text describes a 510(k) submission for a medical device, the Porous Morphix® Suture Anchor with Force Fiber® Suture. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202) based on:

• Same Intended Uses: The new device has the same indications for use as the predicate.
• Equivalent Technological Characteristics: Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports this equivalence.
• Minor Differences: The differences are an extruded porous layer on the top surface of the device and a change in suture supplier. These differences were determined not to raise questions concerning safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These points are relevant to AI/ML device validation, which is a different regulatory pathway and type of study than what is presented in this 510(k) summary for a physical medical device (suture anchor).

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