Search Results

TRIGEN MAX Tibial Nail System:

The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.

INTERTAN MAX Hip Fracture Nail System:

The INTERTAN MAX Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures;

ipsilateral femoral shaft/neck fractures; and intracapsular fractures

• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The provided text is an FDA 510(k) clearance letter and associated summary for the TRIGEN MAX Tibial Nail System and INTERTAN MAX Hip Fracture Nail System. This document does not describe a study involving an AI/software device that requires specific acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Instead, this clearance is for mechanical bone fixation appliances and accessories, which are physical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) performance evaluations and biocompatibility testing to demonstrate substantial equivalence to predicate devices, not AI algorithm performance.

Therefore, I cannot provide a response with the requested information template (table of acceptance criteria with reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, and ground truth establishment for training set) because those metrics and study types are relevant for AI/software medical devices, which this submission is not for.

The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject devices. The performance bench evaluations and tests were used as a basis for the determination of substantial equivalence. The results of each evaluation or test show that when compared to the predicate devices have demonstrated substantially equivalent performance."

The types of "acceptance criteria" for these devices are related to mechanical properties and material compatibility, derived from standards like ASTM and ISO. These are not presented in a quantitative performance table like for an AI device.

To summarize, based on the provided document:

• This submission is for physical metallic bone fixation appliances, not an AI/software device.
• Therefore, the requested information template for AI device performance and validation studies is not applicable.
• The "studies" performed were non-clinical benchtop tests (e.g., Finite Element Analysis, Insertion/Removal Torque, Fatigue Testing, Biocompatibility).
• The "acceptance criteria" are implied by meeting the requirements of the referenced ASTM and ISO standards for substantial equivalence to predicate devices.

Ask a specific question about this device