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The MedShape, Inc., Eclipse™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing procedures:

• Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
• Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
• Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

The proposed Eclipse™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The Eclipse™ Soft Tissue Fastener is designed to use the principles of interference fit to reattach soft tissue intended for insertion into a hole created in bone.

The Eclipse™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue aqainst the bone wall; fastening it into place.

The provided text describes a medical device, the Eclipse™ Soft Tissue Fastener, and its 510(k) summary for FDA clearance. However, it does not contain the information requested about acceptance criteria for a study proving device performance in the context of an AI/ML device.

Here's why and what information is missing:

• Device Type: The Eclipse™ Soft Tissue Fastener is an orthopedic implant for tissue fixation to bone. It's a physical medical device, not an AI/ML software device. The questions about "test set," "ground truth," "experts," "MRMC study," and "training set" are specific to AI/ML device validation.
• Study Details: The document mentions "functional performance testing has been conducted in Sawbone® bone analogue. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility)." This describes physical performance testing relevant to an orthopedic implant, not a study for an AI/ML algorithm.
• Acceptance Criteria: While specific performance metrics like "pull-to-failure" strength are mentioned, the document does not present them as a formal table of acceptance criteria with corresponding reported performance values, as would be expected for an AI/ML device's validation.

Therefore, I cannot provide the requested information for acceptance criteria and the study proving the device meets them because the provided text describes a physical orthopedic implant, not an AI/ML device, and lacks the specific validation study details pertinent to AI/ML systems.

If you have a document describing an AI/ML device and its validation study, I would be able to extract the requested information.

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