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TheraMicro TeKBrace Knotless Anchors are intended for use in the following applications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus reconstruction, Midfoot reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 Only), Medial collateral and Lateral collateral ligament repair, Patellar tendon repair and Posterior oblique ligament repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Quadriceps Tendon Repair (4.75 Only), Meniscal Root Repair (4.75 Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 only), MPFL Repair/Reconstruction (3.9 Only)

Hand and Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament and Ulnar collateral ligament reconstruction.

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm only), and Proximal Hamstring Repair (4.75 - 5.5 only).

The TeKBrace Knotless Anchors are part of the TeKBrace System which is intended for the fixation of soft tissue to bone. The TekBrace Knotless Anchor consists of a two-piece anchor manufactured from polyetherether-ketone (PEEK) and is available in three sizes (3.9mm, 4.75mm and 5.5mm). The knotless anchor is a sterile two-component suture anchor comprised of an eyelet and hollow anchor body. The TeKBrace Knotless Anchor will be provided in a kit also containing the TeKBrace Solo Soft Tissue Reinforcement Device previously cleared in K251063. Additionally, anchors and eyelets may be provided packaged separately for convenience. All devices are single-use only and provided sterile via gamma irradiation.

There are two kit configurations including the TekBrace Knotless Anchor and TekBrace Solo Devices. In these configurations the TekBrace Solo acts as the suture when compared to predicate devices with an anchor / suture construct. The anchor may be provided preloaded with TeKBrace Solo on an inserter or the anchor may be provided not pre-loaded, but in the same packaging as the TeKBrace Solo Device. Both configurations include the instruments required for the procedure.

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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.

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