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The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

Device Description

The BioBrace™ implant is a bioresorbable, biocomposite 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 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.

AI/ML Overview

The provided text describes the BioBrace™ Implant, a bioresorbable, biocomposite scaffold intended for reinforcement of soft tissue. The document focuses on demonstrating the substantial equivalence of the BioBrace™ Implant to a predicate device (STR GRAFT, K121216) and several reference devices rather than establishing novel acceptance criteria for a new type of device. Therefore, the information provided relates to testing parameters and comparable performance, rather than distinct acceptance criteria for the device's function as an AI or diagnostic tool.

The document does not describe a study involving an AI algorithm or human-in-the-loop performance, so many of the requested categories for AI-related studies are not applicable.

Here's the information extracted from the provided text, primarily focusing on the performance data and comparative studies as they relate to device safety and effectiveness.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with direct quantitative thresholds that the device had to meet to be proven effective in a standalone capacity. Instead, it details performance tests conducted and compares the results to predicate/reference devices or established biological norms. The implied acceptance criteria are that the BioBrace™ Implant performs equivalently to the predicate device and demonstrates acceptable biocompatibility, mechanical integrity, and biological response.

Acceptance Criterion (Implied/Tested Aspect)	Reported Device Performance (BioBrace™ Implant)
Biocompatibility	No adverse biological response per chemistry, Toxicological Risk Assessment (TRA), and ISO 10993 assessments (Cytotoxicity, Local Implantation Effects, Irritation/Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity).
In vivo ovine study showed "minimal to no reaction" per ISO10993-6 criteria, normal healing response, and no evidence of adverse reactions macroscopically, radiographically, or histologically.
Mechanical Integrity (in vitro)	Fluid Uptake: >300% (measured gravimetrically, per ASTM F-2212), "significantly higher than FiberTape."
Mechanical Properties (various): Maintained through healing per in vitro testing at 37°C in PBS at 6, 12, and 26 weeks. Tested parameters included ultimate tensile strength, tear resistance strength, suture pull-through strength, ball burst strength (per ASTM standards D882-10, D226, D3787); PLLA polymer fiber properties (per ASTM D2857 and D3418); collagen, fluid uptake, and absorbance properties (per ASTM F2212).
Mechanical Integrity (in vivo augmentation)	Pull-out strength (ovine extensor tendon): Statistically significant increase with BioBrace augmentation: 656 ± 87 N (with BioBrace) vs. 457 ± 70 N (without BioBrace).
Stiffness (ovine extensor tendon): Statistically significant increase with BioBrace augmentation: 175 ± 22 N/mm (with BioBrace) vs. 124 ± 29 N/mm (without BioBrace).
Ultimate Tensile Strength (ovine rotator cuff repair): Increased from time-0 (1163 ± 303N) to 6-weeks (1740 ± 338N) and to 12-weeks (2463 ± 484N).
No significant difference in UTS between BioBrace repaired tendons and contralateral native control tendons at 12-weeks (2463 ± 484N vs. 2707 ± 605N).
Biological Response (in vivo)	Rapid tissue and cellular infiltration (6-weeks) in ovine model.
Low to no adverse tissue/cellular inflammation per ISO 10993-6 scoring.
Normal healing response, progressive new tissue formation and integration, neovascularization, fibroblast activity, and new blood vessels at host/implant interface and within porous structure. Local tissue response included low numbers of macrophages and multinucleated giant cells with scattered lymphocytes.
Sterilization	Validated to 10⁻⁶ SAL (Sterility Assurance Level) with ethylene oxide per ISO 14937:2009. Max EO residual limits met per ISO 10993-7:2008.
Endotoxin Levels	Met acceptance criteria of

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