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The OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor are intended for use in soft tissue to bone fixation in the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
Foot and Ankle Achilles tendon repair
Foot and Ankle Medial/lateral repair and reconstruction
Foot and Ankle Plantar plate repair
Foot and Ankle Mid- and forefoot repair
Foot and Ankle Metatarsal ligament/tendon repair or reconstruction
Shoulder Rotator Cuff
Shoulder Shoulder Instability
Shoulder Biceps Tenodesis
Elbow Lateral epicondylitis repair
Elbow Biceps tendon reattachment

The OC JuggerKnotless® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to two non- absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, or black Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

The OC JuggerLoop® Soft Anchor is comprised of a suture sleeve structure and shuttling and cinching suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to two non-absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, or black. Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a standard or self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use, OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor, and its substantial equivalence to a predicate device. However, it does not contain information typically associated with the acceptance criteria and study design for AI/ML-based medical devices. The document is an FDA 510(k) clearance letter and summary for a physical medical device (bone fixation fastener), not a software or AI/ML device.

Therefore, the requested information regarding acceptance criteria, reported device performance in a table, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document because these concepts are not applicable to the type of device described.

The document discusses the following:

• Device Type: Soft Anchors for soft tissue to bone fixation.
• Regulatory Classification: Class II medical device (21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener).
• Performance Data: Non-clinical mechanical testing (insertion, cyclic, and pullout testing) and usability engineering validation in cadaveric models.
• Conclusion: The device is substantially equivalent to a predicate device based on intended use, principle of operation, materials, packaging, sterilization, and comparable performance in non-clinical testing.

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