(56 days)
The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device 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 extra-articular ligaments.
The TeKBrace Solo Soft Tissue Reinforcement Device 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, spring 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 TheraMicro TekBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used for reinforcement of soft tissue. The product is offered in a central tubular weave tape that tapers down to cords at both ends. The implant is available in two sizes. The device will have pockets which provide access to the inside of the tubular section. The product is substantially equivalent in material and manufacturing compared to the Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978 and K220091). TekBrace Solo is similar to the Xiros Infinity-Lock predicate in intended use, material and design, including a central tubular section tapering down to cords at the end.
TekBrace Solo is manufactured from non-absorbable polyethylene terephthalate (PET), commercially known as polyester. The implant is manufactured from fibers of long-chain, linear polyester having recurrent aromatic rings. The device also incorporates Cottony II green PET suture for pocket location visibility.
The provided document is a 510(k) Clearance Letter for a medical device called the "TekBrace Solo Soft Tissue Reinforcement Device." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through performance testing related to mechanical properties and biocompatibility.
Crucially, this document does NOT describe a study involving an AI/Machine Learning device or a diagnostic device that would require the type of acceptance criteria and performance study details described in your prompt (e.g., sensitivity, specificity, MRMC studies, expert ground truth establishment for medical images).
The "TekBrace Solo Soft Tissue Reinforcement Device" is a surgical mesh (a physical implantable device), not a software or AI product. Its clearance is based on:
- Materials: Polyethylene terephthalate (PET)
- Design: Tubular weave tape with cords, pockets for access.
- Manufacturing process.
- Intended Use: Reinforcement of soft tissues in tendon/ligament repair.
- Performance Testing:
- Tensile testing (ultimate tensile strength, fixation strength)
- Fatigue testing (tensile strength following fatigue)
- Endotoxin testing (biocompatibility)
Therefore, I cannot extract the information requested in your prompt (acceptance criteria for AI/ML, sample sizes for test/training sets for AI, expert consensus, MRMC studies, etc.) from this document because it pertains to a different type of medical device and a different regulatory pathway.
To answer your prompt effectively, I would need a 510(k) clearance letter or summary for an AI/ML-driven medical device, ideally one classified as a diagnostic imaging device or similar, that discusses clinical performance studies with metrics like sensitivity, specificity, or AUC.
If you provide such a document, I would be happy to populate the requested table and study details.
§ 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.