(125 days)
BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extraarticular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, soring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
The BioBrace® implant is a bioresorbable and bioinductive scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly- L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 micron filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm3, and median pore diameter of 19 microns. The highly porous collagen sponge comprises the majority of implant surface area (0.7 m2/gram) versus the PLA filaments alone (0.2 m2/gram), creating a large biologic matrix for cellular ingrowth, tissue regeneration, and healing. BioBrace implants are approximately 3 mm thick, provided in multiple sizes, and provide for soft tissue and tendon augment, and clinically relevant strengthening of the surgical repair. The BioBrace implant is single-use and supplied sterile with SAL of 10-6.
This document is a 510(k) Summary for the BioBrace® surgical mesh. It details the device, its intended use, and comparative studies for substantial equivalence. However, it does NOT contain the specific information required to answer your prompt about acceptance criteria and the study that proves the device meets those criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, AI-based device and then proving them. The prompt asks about an AI/algorithm-based device and its performance metrics, such as sensitivity, specificity, or reader improvement. This document describes a surgical mesh, which is a physical implant, not an AI or software device.
Therefore, I cannot provide the requested information based on this document. The document primarily discusses:
- Device Description: Bioresorbable and bioinductive scaffold made of collagen and PLLA yarn.
- Intended Use/Indications for Use: Reinforcement of soft tissue, particularly in tendon and ligament repair, including expansion to extra-articular ligaments.
- Technological Comparison: Emphasizes that the subject device is identical to the primary predicate (K203267) in design, materials, manufacturing, and sterilization, with new sizes and expanded indications for use being the primary changes.
- Non-Clinical and/or Clinical Tests Summary & Conclusions: Mentions cadaver-based studies, an in-vivo study in sheep, and literature reviews to support the expanded indications and performance characteristics like bioinductivity, strengthening, and stiffness.
There are no details related to an AI/algorithm device, its acceptance criteria (like sensitivity, specificity, AUC), test set characteristics (sample size, data provenance), ground truth establishment by experts, or MRMC studies, as would be expected for an AI device submission.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.